Restless Legs Syndrome Foundation Blog

Call for RLS Research Grant Proposals

The RLS Foundation, a 501(c)(3) nonprofit corporation, aspires to achieve universal awareness of the disease, to support identification of effective treatments, and to find the cure for the millions of men, women, and children who suffer from RLS.

The RLS Foundation calls for grant proposals of a 1 year-duration, with funding levels of up to $50,000 (including 8% for F&A costs), based on the number of funded applications. A renewal or extension of a proposed project may be considered, but this extension would be subject to the regular competitive approval process for year 2.

Spring 2024 Priorities

For this round of funding, the primary research priorities are:

• Neurobiological interaction:Elucidate the points of interaction between RLS-relevant neurotransmitters, neuronal pathways, and iron deficiency.
• Pharmacologic treatments:Elucidate effects of novel pharmacological approaches on RLS.
• Clinical Practice:research based on innovations in patient care delivery including but not limited to population health programs, technology-enabled healthcare delivery (i.e.; telemedicine) and public health initiatives.
• Other topics: Other research areas accepted for funding consideration.

Requirements

• Eligibility: All institutions within the United States, Canada, and other countries where supervision of grant administration is possible are eligible.
• Human Subject Protection: Approval by the institution’s human investigation committee is necessary for all projects that involve human subjects.
• Recombinant DNA Research and Animal Welfare: The RLS Foundation has adopted the regulations pertaining to these areas, as established by the US Public Health Service.
• Multiple Awards: Individual investigators may receive a maximum of one RLSF grant award of any kind in a given year.

Application process

• Submission is a two-step process requiring both preapplication (letter of intent) due no later than January 26, 2024 and full application as indicated below.
• The application title and all information for the Principal Investigator (PI), Business Official(s), Performing Organization, and Contracting Organization must be consistent throughout the entire preapplication and full application submission process.
• If a joint submission by multiple PIs (Partnering PI Option): The Initiating PI must complete the preapplication submission process and submit the contact information for the partnering PI. The Partnering PI(s) will then be notified of the preapplication submission separately by email.
• Fund disbursement for successful applications will be contingent upon documentation of approved institutional review or animal user protocols, as appropriate.

Preapplication (Letter of Intent) Submission Components

The Letter of Intent (LOI) should consist of preproposal narrative with:

• Rationale: State the hypothesis and reasoning on which the proposed research project is based. Briefly describe how preliminary data, scientific rationale, and referenced literature support the research hypothesis. Clearly demonstrate that there is sufficient rationale for the project (Limit: 500 words).
• Focus Area: State the Research Priority that the proposed study seeks to address. Select one or more from the current research priority list.
• Specific Aims and Study Design: Clearly describe the type of research study being proposed. Concisely state the project’s objectives, specific aims, and ultimate endpoints. As applicable, briefly describe the proposed recruitment strategies and methods, how they will accomplish the project’s aims, as well as the outcome measures that will be used. (Limit: 500 words)
• Research Team: Provide a description of the research team that clearly demonstrates the appropriate background and experience to accomplish the proposed work. (Limit: 250 words)
• Impact and Relevance to RLS: Describe how the proposed work will impact healthcare and quality-of-life needs for patients and/or family members or beneficiaries living with RLS. (Limit: 250 words)

In addition, applicants should provide a reference list (one-page limit), list of abbreviations, acronyms, and symbols, and key personnel biographical sketches (NIH format).

Letter of intent (see attached sample application) to be submitted starting December 8, 2023 online here by no later than January 26, 2024.

Applicants will be informed the second week of February if their proposal will be invited for a full application.

Full Application Submission Components

If selected, the full online application consists of a cover page that must be signed by the university or organizational representative(s) and the principal investigator, an abstract with a clearly stated hypothesis, and the proposal that includes:

Project Narrative (no more than 5 pages), with background, hypothesis / objective, specific aim(s) and research strategy. Within the research strategy section, describe the study design, methods, models, and analyses in sufficient detail for assessment of the application. Explain how the research strategy will meet the project’s goals and milestones within the proposed period of performance. Address potential pitfalls and problem areas and present alternative methods and approaches. For studies performing prospective human subject recruitment or observation: Describe the population(s) of interest. Describe how data will be reported.

Budget and budget justification

Biographic sketches of each investigator (NIH format)

Disclosure of previous RLS Foundation support and other sources of funding.

Full Applications to be submitted online, link to be provided in LOI acceptance notification, and the deadline for the full proposal submission is April 5, 2024.

Award Process

Schedule: The RLS Foundation Scientific and Medical Advisory Board (SMAB) and external reviewers strives to review all applications in a timely manner. The goal is to provide the results to the LOI applicants within 2 months of the respective grant deadline and 4 months after submission of the full proposals.

Review: The SMAB will evaluate and rank the full proposals based on scientific merit. Overall impact, significance, approach, innovation (conceptual, technical) and individual criteria will be taken into account for funding consideration.

Award: The RLS Foundation Board of Directors will make final award decisions in accordance with available funds, based on the evaluation provided by the SMAB and other prioritization factors as determined by the Board of Directors.

Recipient Requirements: In order to receive an RLS Foundation research grant, the recipient must:

1. Within one month of the grant award, provide a photo of the grantee and a one-page article for publication in NightWalkers (the Foundation’s quarterly news magazine), describing in layman’s language the importance of the research to the RLS community and the recipient’s intention for future research.
2. Use the terminology restless legs syndrome in all grant-related publications and correspondence.
3. For 1-year awards, agree to submit a progress report after 6 months and 12 months from the starting date of the grant.
4. Acknowledge the RLS Foundation’s support in any published work or audiovisual productions resulting from research that the Foundation has supported. (Provide pdf copies of any reprints to the Executive Director of the RLS Foundation.)
5. Agree, if RLS Foundation funded research is commercialized or generates revenues, to devote a portion of the revenues to repaying the entire amount of the grant received, plus interest at the-prevailing prime rate, to the Foundation. Interest will be calculated semi-annually on the unpaid portion of the amount to be repaid.

Lastly, the intent of the RLS Foundation Research Grant Program is to provide seed monies to support researchers in their research endeavors and help them obtain the data to successfully request large scale funding elsewhere.

Thus, while an application may be also submitted to other organizations or agencies for funding, the applicant may not receive funding from the RLS Foundation, if any of those other projects are awarded or funded prior to the award being granted by the RLS Foundation.

The applicant will notify the RLS Foundation in writing of award funding for the same proposal from another organization and withdraw the application from consideration.

Costs Not Permitted

The following costs are not allowable under the RLS Foundation’s grant programs:

• New construction, alterations, or renovations of existing facilities
• Consultant fees, unless specified in the original grant application
• Travel costs

RLS Research Grant Program

The RLS Grant Program started in 1997 and has funded 50 grants totaling nearly $2 million. Membership giving is the primary funding support of the RLS Foundation Research Grant Program. Help us to continue to fund promising new RLS research and end RLS for future generations.

Your Generosity Can Change Lives: The Power of Giving Tuesday

Among the busyness of the holiday season, don’t forget to pause and reflect on the friends, family and organizations that have positively impacted your 2023 year. Giving Tuesday, which is celebrated on the Tuesday following Thanksgiving, is a global movement that encourages people to contribute to the charitable organizations that largely influence their lives. As you harness compassion and generosity during this season of giving, consider extending it to the Restless Legs Syndrome (RLS) Foundation. Participating in Giving Tuesday at the RLS Foundation is an opportunity to make a difference and support those suffering from this often devastating disease.

The Impact of Giving Tuesday

Your participation in Giving Tuesday is essential for providing the means to fund critical research that aims to improve diagnosis methods, better our understanding of RLS, and develop more effective treatments. You become part of the solution to this complex medical challenge. Further, Giving Tuesday offers a unique opportunity to connect with the RLS community. People from all walks of life come together with a shared purpose – to support those living with RLS. You can become part of a supportive network that provides comfort and encouragement to individuals and families affected by RLS.

Education and Awareness

Another crucial aspect of the RLS Foundation’s mission is enhanced education and awareness. Through Giving Tuesday donations, the Foundation can create and distribute valuable resources, organize awareness campaigns, and promote a better understanding of RLS among healthcare professionals and the public. Our resources include over 30 patient handouts, a monthly webinar series, a quarterly magazine NightWalkers, and a free physician education webinar series. By participating in this annual event, you help dispel the misconceptions and stigmas often associated with the condition.

The Joy of Giving

Your participation in Giving Tuesday at the RLS Foundation extends far beyond just supporting a good cause; it’s also about experiencing the joy of giving. The act of contributing to something greater than oneself can be immensely fulfilling. Knowing that your donation, no matter how small, can make a difference in someone’s life is a powerful motivator and a source of personal satisfaction.

The importance of Giving Tuesday lies in its ability to inspire philanthropy and unity and serves as a powerful reminder of the impact we can collectively achieve as a community. Your participation will further our outreach related to RLS research, advocacy and education. So, mark your calendar for Tuesday, November 28, open your heart, and make a meaningful contribution this Giving Tuesday to help the RLS Foundation in its mission to improve the lives of countless individuals living with RLS.

The Knowledge and Comfort of Knowing You Are Not Alone = Priceless

For 31 years, the RLS Foundation has been dedicated to improving the lives of the men, women and children who live with RLS by increasing awareness, improving treatments, and funding research to find a cure for this often-devastating disease. The RLS Foundation is proud to have the only dedicated RLS Research Grant Program, which funds promising research. We are a patient services organization, committed to ensuring those in the RLS community have access to top-notch resources, support, information and much more. Membership dues from our cherished members are the lifeblood of this organization, and our work can’t be done without you, our members.

FIVE REASONS WHY YOUR MEMBERSHIP IS BENEFICIAL

1. ACCESS TO EXPERT RESOURCES

Members can tap into a wealth of knowledge about RLS, including the latest research, treatment options and management techniques. The Foundation offers comprehensive educational materials, such as educational brochures, open-access articles and webinars, which can empower you with a deeper understanding of your disease. All of our publications are available for immediate download through our Member Portal, as well as an archive of webinars on a variety of topics. Our materials are rigorously reviewed and edited by members of our Scientific and Medical Advisory Board. These RLS experts volunteer their time and expertise to ensure all our materials are up-to-date and scientifically accurate.

2. A CARING AND SUPPORTIVE COMMUNITY

Being an RLS Foundation member means you have access to a support system made up of thousands of individuals living with RLS across the globe who can empathize with what you are going through. You are no longer alone in your RLS journey. An RLS Foundation membership gives you discounted pricing on events such as our upcoming National RLS Patient Symposium, where you will meet individuals from all over the country and foster lifelong connections with those in your same shoes. Sharing personal stories, triumphs and challenges with others who can relate provides a sense of camaraderie and emotional support that can be invaluable for individuals coping with RLS.

3. CREATING YOUR LEGACY THROUGH ADVOCACY

Members of the RLS Foundation have the chance to actively participate in advocacy efforts that aim to raise awareness about RLS and improve the lives of those living with the disease. Through the Foundation’s initiatives, you can contribute to public policy discussions, promote research funding, and collaborate with healthcare professionals to advance the understanding and treatment of RLS. By joining forces with like-minded individuals and making your voice heard, you have the power to affect meaningful change and make a lasting impact on the RLS community for future generations to come.

4. THE ONLY DEDICATED RLS RESEARCH GRANT PROGRAM

As an RLS Foundation member, you contribute to the Foundation’s efforts to fund research and drive advancements in the field of RLS. The financial support from membership fees and donations directly fuels research projects such as small clinical trials to investigate new treatment options, with the end goal of finding a cure. By actively supporting these initiatives, you play an instrumental role in accelerating progress, ultimately benefiting not only yourself but also future generations affected by RLS.

5. EXCLUSIVE MEMBER-ONLY BENEFITS

In addition to the broader benefits of knowledge, community, advocacy and research advancements, RLS Foundation members enjoy exclusive perks. These include discounts on RLS Foundation merchandise in our online store, priority registration for events and conferences, and access to special member-only content in the Member Portal on our website. Four times a year, each member receives our quarterly news magazine, NightWalkers, which is meticulously planned, written and edited to deliver news about the latest happenings at the RLS Foundation and in the RLS realm. Our members also receive our Special Accommodations Card for use when traveling, along with our Medical Alert Card, which outlines medications that often trigger RLS and provides safe alternatives.

From gaining access to expert resources and support from a community of peers, to actively participating in advocacy efforts and contributing to research advancements, an RLS Foundation membership offers a comprehensive range of benefits. By joining or renewing, individuals not only empower themselves with knowledge and support but also contribute to the overall mission of improving the understanding and treatment of RLS to improve the quality of life for those living with the disease. The nominal fee to join or renew your membership is $40, but the benefits that come with it bring peace of mind in knowing that you are a member of an active and supportive community that alone is priceless.

Hope for a Better Future

My RLS started very gradually – I really didn’t think much about it at the time. About 15 minutes into my meditation, I had this creepy-crawly, gnawing feeling in my legs. I found I could tighten my leg muscles, the feeling would subside, and I could then start my day. This feeling would appear intermittently from time to time, with increasing frequency until about 18 years ago. It became such a persistent and growing problem that I had to stop meditating. Then this issue began to interfere with my sleep. Just when I started to dream, I was suddenly awakened by an uncontrollable leg jerk. That’s when I decided it was time to ask my physician about this problem.

My doctor had the vague idea that I might be suffering from restless legs syndrome (RLS). She performed a blood test to check for iron deficiency, then wrote a prescription for quinine. For those who are unfamiliar with quinine*, it really did help with my RLS, though not consistently. However, I soon discovered that quinine has an insidious and horrifying consequence. Quinine kills bacteria. My intestinal flora was now a decimated wasteland (no pun intended). To say I was a difficult person to be around was a noxious understatement. I may not contract malaria, but I was destined to live my life as a hermit, alone and without human contact.

After about six months, my wife decided to schedule another appointment with my doctor. She said she was concerned for my health; I was not convinced that was her motive. My doctor prescribed ropinirole**, a drug many with RLS have been on. Fortunately for me (and my wife) the drug worked like a dream, literally. I could finally fall asleep provided I took the medication several hours before bedtime. My downfall was that in the evening, I would fall asleep on the couch if I sat still for 10 minutes or so. This was embarrassing when went to someone’s house for dinner and would sit for conversation after the meal, and within a short while I was snoring. Eventually, I let go of my embarrassment, as my wife would explain to our hosts the challenges of my medication. I also discovered that this was a great way to escape conversations that didn’t interest me. I would just close my eyes and willfully drift off.

My next pharmaceutical experience came when I changed physicians. My new doctor suggested I try pramipexole (Mirapex). He felt it could have less of a tranquilizing effect yet still provide the RLS relief I needed. He was right. For seven or eight years, this medication was consistent so long as I took it two hours before bedtime.

But it seems all good things must come to an end. For me, augmentation started subtly. I found I needed a little bit more medication to manage my RLS. I also had to adjust my schedule by taking it a half-hour earlier. Soon the augmentation dramatically changed. On bad nights, not only did my arms and legs violently jerk, but also I could feel it in the core of my body. Some nights while trying to fall asleep on the couch, I would be in tears at 2 or 3 o’clock in the morning. “Horrible” doesn’t begin to describe the problem.

Out of desperation, and following an article in NightWalkers about augmentation, I started to search for an RLS specialist. I called the Norman Fixel Institute for Neurological Diseases at Shands in Gainesville, Florida – a three-hour drive from my home. After a thorough review of my medical history, my newest doctor started me on a regimen of 600 mg of gabapentin, increasing it to 900 mg after six months. At the next appointment, we would discuss the reduction of Mirapex. Within three weeks, I decided I needed to be more aggressive with my therapy by reducing the Mirapex sooner. Through constant communication with my neurologist and my own assertive impatience, we were able to move me out of dopaminergic dependency, replacing Mirapex with 600 mg of gabapentin within eight months of my first exam. Needless to say, I am elated. I no longer need medication before boarding a plane or taking a long road trip. I can stay up late again if I want to. Chocolate, caffeine and alcohol no longer make me twitchy. I feel so much freer than I have in decades.

I understand that each of us is unique, and results will vary, but I stand before you as a positive example of what can be accomplished. You have a whole world of RLS sufferers who are behind you, cheerleading you on to success. Don’t give up! There is always hope for a better future.

Dan and his wife, Lara, keep pretty busy with their successful optical office in Port Saint Lucie, Florida. In his spare time, his hobbies include traveling, bookbinding, jewelry making, and numerous other activities (Attention Deficit Disorder is both a blessing and a curse)! They have a five-year- old granddaughter who lives too far away in Connecticut.

*Quinine has no proven effect on RLS except for a placebo effect. Quinine may kill bacteria but there is no real documentation of negative effects on the intestinal flora. The real concern with quinine (which is why it requires prescription and only approved for treating Malaria and not leg cramps) is its rare side effects of cardiac arrhythmia and blood dyscrasias.

**Ropinirole is no longer considered first-line treatment for RLS.

Frequently Asked Questions About RLS Foundation Membership

At the RLS Foundation, we appreciate your support through membership. All RLS Foundation members can be proud of the part they play in making our mission a reality and reaching our goals to improve treatments and, through research, find a cure. If you have additional questions about membership, email info@rls.org or call (512) 366-9109.

New Membership

Q: What do I receive when I become an RLS Foundation member?

A: When you sign up for an RLS Foundation membership, you will receive a new member packet in the mail (or via email for international members) that includes the most recent edition of NightWalkers; up-to-date publications on the diagnosis, treatment and management of RLS; helpful handouts to carry with you, like the Medical Alert Card and Special Accommodations card for travel; and more! In addition to these benefits, you will gain unlimited access to resources through the online Member Portal, which contains all RLS Foundation publications, webinar recordings and an archive of all NightWalkers issues.

Q: Is there an annual membership fee?

A: The RLS Foundation receives the majority of its funding from membership and individual donations, plus a small portion from grants. RLS Foundation memberships have an annual fee of $40. Over 77% of funds raised go directly toward RLS Foundation programs, including member/patient services, awareness outreach and educational resources developed by medical experts, and funding for the only research grant program dedicated to RLS.

Q: Is my membership fee tax deductible?

A: Yes. Because the RLS Foundation is a 501(c)(3) not-for-profit organization, all contributions – including membership fees and donations – are tax deductible up to the full extent permissible by law. Emails and letters from the Foundation acknowledging your donation serve as gift acknowledgments for tax purposes.

Q: How do I become a member?

A: Choose one of three easy ways: 1) Go to www.rls.org/become-a-member to provide your contact information and pay with a credit card; 2) Call us at (512) 366-9109 to provide all information by phone; or 3) Download a new member form at www.rls.org/joinform and mail the completed form along with a check payable in US funds to the RLS Foundation. Memberships take up to 24 business hours to process.

Q: Is financial assistance available?

A: Absolutely. In addition to offering discounted membership specials twice a year, scholarship memberships are available at no cost to those in need. If Foundation membership is outside of your budget, please email us at info@rls.org or call (512) 366-9109 to request a free or discounted scholarship membership.

Membership Renewal

Q: When does my membership renew?

A: All annual memberships renew on September 30, according to our fiscal year. However, regardless of your join date, you will receive four issues of NightWalkers (equivalent to one year’s worth of membership) for the calendar year in which you join.

Q: How can I tell if my membership has expired?

A: There are several ways to check the status of your RLS Foundation membership: 1) View the back of your most recent copy of NightWalkers to locate the expiration date of your membership, printed above your name and address. 2) Go online to our website (www.rls.org), click “Member Login,” enter your username and password and click “Renew Your Membership Here.” You will be routed to a page that lists your membership details, including status. IMPORTANT NOTE: Membership status will only be listed if you are first logged into the website with your user name and password. 3) Give us a call at (512) 366-9109 or email us at info@rls.org. We’re happy to check your record in our system!

Q: How do I renew my membership?

A: Go online to our website at www.rls.org/renew, or click “Member Login,” enter your username and password, then click “Renew Your Membership Here.” You can also renew over the phone by calling (512) 366-9109 or by sending a US check payable to the RLS Foundation. Please be sure to specify “Membership” in the memo section of your check.

Q: I accidentally renewed my membership twice. Can you help?

A: A second transaction through the renewal page will be applied as an additional year of membership. If you prefer to apply this as a donation or to request a refund, please contact us right away at (512) 366-9109.

Member Portal

Q: I purchased a membership. Why can’t I open the online resources?

A: After purchasing an RLS Foundation membership, you must also create an online account to gain access to the Member Portal. Go to www.rls.org/login and click “New User Registration.” You will be asked to create a username and a password.

IMPORTANT NOTE: The password must be at least 12 characters, including at least one uppercase letter, one lowercase letter, one number and one special character, and should not include "RLS". Registration requests take up to 24 business hours to be linked to your membership record. We recommend completing this step immediately after purchasing your membership to expedite the process.

RLS Advocacy: One Family Shares Their Story

Advocating for the RLS community and against the barriers posed by existing legislation has always been at the heart of the RLS Foundation (RLSF). Last month, RLSF Executive Director, Karla Dzienkowski, and Administrative Assistant, Adrianna Colucci, flew from Austin, TX to Washington, DC. They were joined by Dr. Shalini Paruthi, dedicated RLSF Board of Directors Chair, and her two sons, Yash and Sanjay, to meet with and educate congressional staff on RLS. Civic engagement such as legislative meetings like this one, is an integral part of the democratic process and helps politicians understand how they can better represent their constituents in policy decisions.

During this July advocacy day, RLS representatives met with Senate and House offices from Texas, where the RLSF office is located, and Missouri, the home of the Paruthi family. This opportunity brought recognition to the Foundation’s legislative priorities to help maintain a presence within federal, state and local offices. The critical issues highlighted within these meetings included increasing research funding, enhancing education and awareness, and protecting access to critical RLS therapies. Most importantly, Dr. Paruthi, Yash and Sanjay, who all have RLS, shared their personal accounts of living with the disease and how it impacts their daily lives.

The morning began in the offices of Senators Josh Hawley (MO) and John Cornyn (TX). Dr. Paruthi is Co-Director of Saint Luke's Sleep Medicine & Research Center as well as an Adjunct Associate Professor at Saint Louis University School of Medicine. Her unique perspective as both an RLS provider and an educator allowed her to speak on the importance of sleep medicine education in the medical and academic setting. Within a medical student’s own schooling, they may receive no more than one hour of education on sleep medicine. She sees the impact of this deficit as a pediatric sleep physician, since it has been shown that RLS is often underdiagnosed or misdiagnosed in children due to an adolescent’s inability to express symptoms, or symptoms being attributed to other conditions such as “growing pains” or the inability to sit still often seen with ADHD.

Yash and Sanjay, Dr. Paruthi’s children who also have RLS, shared their passion for sleep advocacy within congressional offices. For Yash, sleep and RLS awareness is particularly valuable for children and teenagers. As a high school student, he witnesses how sleep deficits impact “grades, academic performance, athleticism, and the ability to focus” in his peers. Good sleep is a necessity for everyone, especially during the developmental years of childhood and young adulthood. Proper diagnosis and effective treatments at a younger age help prevent delays in diagnosis which can lead to exacerbated health issues and increased mental health issues in adulthood. As Yash prepares for his junior year in high school, he will continue to value the importance of sleep, particularly in his planned future career as a doctor.

Rising 8th grader, Sanjay, described how his own RLS symptoms impact his sleep and daytime routines, sometimes causing difficulties in concentration in the afternoon. Sanjay is hyper-aware of the importance of sleep (thanks to his sleep specialist parents!) and notices the all-too-common discussions he has with his own friends over lack of sleep. For legislators, the most compelling narratives come from personal anecdotes, like Yash’s and Sanjay’s. Representatives from the Senate offices were engaged and asked questions to learn directly from their constituents, whose personal testaments provided insight into a disease that representatives had most likely never heard of. By providing a name, a story, and human sentiment to a cause, it allows policymakers to recognize the implications of policy on real people and their communities.

The afternoon focused on meetings with representatives from House Members Michael Burgess (TX), Marc Veasey (TX) and Anne Wagner (MO). RLSF staff continued to emphasize the necessity of funding federal programs such as the National Institutes of Health to help researchers access grants when conducting RLS clinical trials and allocating resources to programs such as the Chronic Diseases of Education and Awareness. Karla Dzienkowski, who speaks with RLS physicians, patients, and even family members daily, emphasized the need for continued research with representatives.

“Here at the RLS Foundation, we are dedicated to improving the lives of those who live with RLS, through advocacy, support, and funding research for improved treatments, ultimately a cure. Sleep disorders such as RLS continue to be misunderstood and underdiagnosed, so our goal here today is to encourage lawmakers to consider a large portion of the population that is overlooked. About 1 in 33 Americans – 3 percent of the US population – has RLS that is severe enough to need daily medical treatment. Sleep plays a critical role in the quality of life, mental health and long-term physical health and well-being. Heightened research and awareness will considerably benefit the constituents [they] represent within [their] own communities.”

Further, legislators were asked to consider RLS when forming policies surrounding prescription guidelines—policies that will address the opioid pandemic while allowing refractory RLS patients to maintain access to critical therapies, including low-dose total opioids. Each day, the RLSF staff hear from those seeking educational resources for themselves, physicians, and family members, often eager to find a way to regain control of their life and their sleep. Even after quality care is secured, unfortunately, many RLS members must plan for the unexpected—their physician’s retirement, stricter medication regulations, pharmacists unwilling to fill RLS prescriptions or stigma surrounding their management plan. These obstacles create an undue burden on a patient community that truly relies on the accessibility of their medications for stability.

For Yash and Sanjay, this was their first experience meeting and speaking with their legislative offices. Sanjay remarked on the sense of accomplishment he felt by gaining “insight into the democratic process of meeting with representatives and the importance of [his] role in advocacy” while using his voice for issues that were important to him. Advocacy can start in small ways, simply by bringing awareness to RLS in your physician’s office or by speaking with family and neighbors. However, a collective voice that echoes within the walls of your representative’s office contributes to a more robust advocacy effort.

Just like Yash and Sanjay, you can use your story to engage with legislators by joining the RLS Foundation for Hill Day in Washington, DC on October 23rd. Hill Day is an opportunity to become part of a unified movement of educators, dedicated to spreading awareness about RLS and helping legislators understand the significance of the policy that they pass. The RLS Foundation staff is excited to meet you and unite our voices on Capitol Hill! If you have questions about Hill Day, visit our FAQ page or email adrianna@rls.org. Register online now.*

Thank you to Phil Goglas and Matt Duquette of the Health and Medicine Counsel, who guided and coordinated meetings with congressional offices. Thank you to all of the representatives who dedicated their time to learning about RLS and engaging with our cause.

*Registration by October 1 for Hill Day is encouraged. This allows ample time to coordinate meetings with congressional representatives in your state and your district.

We are so excited to share details about our annual RLS Hill Day! Members of the RLS community, RLS Foundation staff, Board members and RLS physicians join together to speak with congressional representatives as their constituents. Advocacy is an integral part of our democratic process, and the RLS community’s voice deserves to be heard. Below is a brief overview of what the day may look like and commonly asked questions. If you have any further questions, reach out to adrianna@rls.org.

Tentative Agenda, Monday, October 23, 2023*

8:00 – 9:00 AM: Welcome Session at Health and Medicine Counsel, 50 F St NW, Suite 730, Washington, DC
9:00 AM: Travel to Russell Senate Office Building, 2 Constitution Ave NE, Washington, DC
9:30 – 12:00 PM: Senate Meetings
12:00 - 1:00 PM: Lunch in Senate Building Basement Cafeteria
1:00 PM: Walk to Rayburn House Office Building, 45 Independence Ave SW, Washington, DC
1:30 - 4:00 PM: House Meetings
4:00 PM: Debrief**

*This schedule is tentative and may change based on office availability.
**If you cannot stay for the entire day due to travel times, please let us know before Oct. 1 your approximate departure time.

Preparation

Q. What should I bring with me?

A. A valid ID will be required to enter all government buildings. Bring any notes you have prepared to share with legislators. You can take a small purse with your wallet, ID, camera, portable phone charger, or other personal effects. Water is permitted inside the building. Please leave behind prohibited items including perfumes, aerosol containers, weapons, backpacks, and suitcases as you will go through security.

Q. Is there a dress code?

A. Business casual attire is appropriate. You should wear comfortable shoes as you will be walking/standing for most of the day.

Q. What are the legislative priorities we are advocating for?

A. Put simply, we are advocating for increased funding for RLS research, enhanced awareness and education, and protected access to crucial therapies for refractory RLS which may include opioids. Click here to view the complete legislative agenda.

Q. What is the Health and Medicine Counsel (HMC)?

A. Health and Medicine Counsel of Washington is a government relations organization that works with nonprofit organizations and companies in the healthcare industry. HMC guides our advocacy efforts, including coordinating congressional meetings.

Q. Will we receive training prior to visits with our representatives?

A. There are advocacy materials available on our website under the “Advocacy” Tab or can be accessed by clicking here.

A “Prep Packet” will be distributed a few weeks prior to the event and will include an itinerary, a map of the area, advocacy talking points, the Foundation’s legislative priorities, and a sample meeting outline.

On Monday morning we will have a welcome session with our HMC representatives who will prepare you for the day and answer any remaining questions.

Q. How can I prepare for Hill Day?

A. Step 1: Register at: https://www.rls.org/get-involved/advocacy. Registering in advance allows our HMC representatives to target and schedule meetings with the legislators in your state and district.

Step 2: Create your story. Meetings with representatives will be brief, so preparation is key. Remember, representatives want to hear why policies impact their constituents, which is why your story is so important.

Step 3: Check out our advocacy resources under the “Advocacy” Tab or by clicking here.

Step 4: Plan your travel including hotel reservations, car rentals, public transportation, or other necessary details.

Creating an Effective Story

Q. How do I craft a concise story?

A. Meetings last about 15-20 minutes, so it is important to be concise to allow as many people to share as possible. Prioritize the aspects of your story that represent your struggles most effectively. For more tips, watch our advocacy training video on "How to Craft a Concise Story."

Q. How long should my story be?

A. Please limit it to 3-5 minutes.

Q. What are the most important talking points?

A. Sharing your unique story helps congressional staff members understand how to better serve the constituents they represent. Highlight the struggles you faced in receiving a diagnosis, having access to treatment, and the impact RLS has on your daily life. You are the expert of your own story!

Q. How can I ensure my story is the most impactful?

A. Be respectful and courteous, regardless of political affiliation. Working with both political parties ensures we are heard regardless of who is in office.

Integrate passion into your story. The HMC and RSLF will highlight statistics and facts that support our legislative agenda, but what is most impactful is hearing from you and the very real difficulties faced by your community.

What To Expect

Q. This is my first time participating in any type of advocacy work- what should I expect?

A. Face-to-face advocacy sounds daunting, but it will not take you long to feel confident when meeting with representatives! You will feel a sense of unity among the members of your group knowing you have a collective mission and a sense of empowerment by being a voice for those who cannot be there.

The HMC will coordinate meetings in advance and you will receive the final schedule about a week prior. You will likely meet with 7-10 offices. An HMC representative will guide your group through the meetings.

Your group may include an RLSF employee, a Board member, an RLS expert, other RLS members and an HMC representative.

Q. How is each meeting structured?

A. You will meet with a representative from each office who is there to listen and take notes. These meetings last about 15-20 minutes. Do not be surprised if your meetings take place in a conference room, the office lobby, or even the hallway!

An HMC representative will introduce the group, each participant will introduce themself. An RLSF representative will explain what RLS is and what the RLS Foundation does. You will share your story and explain your challenges in 3-5 minutes. The HMC rep will end with our legislative priorities and request their support. The flow of your meeting will happen naturally, as your group learns how to bounce off each other’s statements.

Q. What is my role in this meeting?

A. Statistics and numbers only go so far- the most impactful statements come from those who live with RLS and can provide context for the adversities faced by the community. Provide your realistic experience and highlight that while everyone’s story is different, there are common struggles that RLS patients endure.

Q. How is it decided which representatives we meet with?

A. HMC will organize groups, which may be based on your state residency. When coordinating meetings, they target legislators based on constituency.

Q. What do I do if I am asked a question that I do not know the answer to?

A. If you are asked a question that you do not know the answer to, no worries! You are there to share your story, not to act as a medical expert. All medical questions will be answered by staff or an appropriate medical professional in your group.

Q. Should I follow-up with the representatives I meet?

A. The RLS Foundation will track representatives spoken to and follow up accordingly. However, you can also reach out on your own by collecting the staffer’s contact information and thanking them for their time.

Q. What are some of the past successes of the Foundation’s public policy initiatives?

A. The RLS Foundation has hosted successful Hill Day campaigns and Virtual Advocacy events in the past. It has allowed us to increase engagement with legislators and meet our legislative priorities, including securing funding for research, and pushing for access to appropriate treatment.

Travel

Q. I am commuting by car. Where can I park?

A. The closest parking structure is Market Square Parking Garage located at 701/801 Pennsylvania Avenue NW. You can reserve a parking ticket in advance for reasonable prices. It is about a 20-minute walk to the meeting area.

Q. Can I commute by train?

A. The HMC office is just a short walk from Union Station.

Q. Q. I am attending the RLS National Patient Symposium. What transportation options are available to get from Baltimore to DC?

A.If you are not renting a car, you may take a taxi or use a riding-sharing service (such as Lyft or Uber) to travel to your destination. The Maritime Conference Center offers free shuttle service to and from the conference center and the MARC/Amtrak Station which has service directly to Union Station in DC.

Q. What airport should I fly in/out of?

A. If you are attending the Patient Symposium, the closest airport to fly into is Baltimore-Washington Airport (BWI). However, if you plan on attending Hill Day, the closest airport to fly out of is Ronald Reagan Washington National Airport (DCA). Make sure to schedule your flights accordingly.

Q. What hotels are in the area?

A. There are plenty of hotels in the area, both within walking distance and driving distance.

Options within walking distance:
- Phoenix Park Hotel: 520 N Capitol St. (10 min walk)
- Hilton Washington DC Capitol Hill: 525 New Jersey Ave NW (10 min walk)
- Kimpton George Hotel: 15 E St. NW (10 min walk)

Options within driving distance:
- Hilton Garden Inn: 2020 Richmond Highway Arlington (20 min drive)
- Lyle Hotel: 1731 New Hampshire Ave NW (20 min drive)
- Cambria Hotel Capitol Riverfront: 69 Q St SW (12 min drive)
- State Plaza Hotel: 2117 E St NW (13 min drive)
- Hilton Washington DC National Mall The Wharf: 480 L'Enfant Plaza SW (8 min drive)

You may need to consider car rentals or ride sharing services as a form of transportation. Be sure to reserve all accommodations in advance!

RLS Foundation Welcomes New Board Chair, Dr. Shalini Paruthi

By Clara Schlemeyer, RLS Foundation Program Coordinator

I recently had the pleasure of interviewing Dr. Shalini Paruthi, who joined the Foundation’s Board of Directors in 2018 and became Chair this year! Dr. Paruthi also dedicates her time to the AASM (American Academy of Sleep). She is certified in both internal medicine and sleep medicine and has extensive expertise in treating both pediatric and adult patients, but her particular interest is in sleep disorders of childhood – obstructive sleep apnea, insomnia, narcolepsy, and – of course – restless legs syndrome. While treating her patients, she is also educating future doctors at Saint Louis University School of Medicine. Her willingness to teach, treat, and share her knowledge is inspiring.

Q. What was your motivation to get involved with the RLS Foundation, and why did you choose to stay involved?

A. My patients are my biggest motivators! I specialize in sleep disorders and have a specific interest in RLS, because I am also an RLS patient. It’s something that I see every day that is easily misunderstood, and there is not enough good, reliable, truthful information available for people. I think one of the most important things that physicians can do is to advocate for our patients. When Karla Dzienkowski reached out to me knowing that I had an interest in RLS, and that my primary focus is on pediatric sleep disorders, it was an excellent opportunity for me to bring my advocacy to the Foundation.

Q. As a physician who specializes in sleep disorders, what knowledge and skills do you hope to bring to the Board as you step into your role as chair?

A. One of the best parts of my day is that I am a teaching physician. I previously taught full-time at Saint Louis University and now am at Saint Luke’s Hospital in Saint Louis. In my role at St. Luke’s, I continue to teach rotators about sleep disorders. I want to make sure that they have a very strong knowledge of all the different sleep disorders, including RLS, which can be very difficult to recognize and diagnose. Sometimes patients cannot articulate their exact symptoms or the symptoms overlap with other medical disorders. As a teaching physician, in every patient visit, I am not only educating the patient but also educating the learners rotating with me.

Additionally, I chaired the program committee at the American Academy of Sleep Medicine for two years. The program committee plans the annual national SLEEP meeting, during which nearly 5,000 physicians, nurses, sleep technicians and sleep researchers gather to share knowledge and learn from one another. That experience enabled me to help with the Foundation’s educational events, such as our virtual Summits and our in-person Patient Symposium, where I served as moderator and educator.

Q. What is your favorite part about serving on this Board?

A. My fellow Board Members! I have met so many people with such different and diverse talents, backgrounds and perspectives, and every one of them is so dedicated to our mission. They want nothing more than to make sure that we are increasing RLS awareness, improving treatments and looking for the best research opportunities. Each Board member is focused on improving RLS diagnosis opportunties and ensuring wider availability of proper treatment. I just see so much passion, dedication and really great teamwork.

Q. How has living with RLS fueled your passion for helping the RLS community?

A. Having RLS, and at times suffering terribly from it, has really opened my eyes to the lack of knowledge surrounding RLS. I am very passionate about educating people about RLS and that it is a serious disorder. It can be so disruptive to a person’s quality of life or their ability to sleep well at night, which then affects their daytime function. For me, it has increased my compassion and empathy for others who suffer from RLS, and I want to do as much as I can within the RLS Foundation to increase awareness and help others know there is hope in finding a treatment that works for them. In addition, we must remind everyone that RLS is also a pediatric disorder with many young children or teenagers having RLS as their cause of insomnia.

Q. What are your future goals and aspirations for the Board?

A. The future goals for the Board are very clearly and appropriately tied to our mission. I hope to increase awareness about pediatric RLS. When a child comes to see me in the office, their parents have already tried all sorts of good sleep hygiene and techniques they have found on the internet, or followed suggestions from family and friends. Yet, they can’t understand what is being so disruptive to their child’s sleep. Often, no one has asked them questions about uncomfortable sensations in the legs or those urges to move in the evenings and the restlessness that comes along with it. Once we diagnose their RLS and begin treatment, they see a huge improvement in their child and the whole family’s interactions. As a Board we are making progress in education, and we must recognize that RLS affects the lifespan, from young children all the way up to older adults.

It is incredibly important for us to request proposals for research projects that can be funded. We have an amazing group of donors who understand just how much RLS affects others, and our best bet is to continue to fund high-quality research that will get us closer to finding better treatments and a cure for RLS. I want to express my deep gratitude for the work of the staff at the RLS Foundation; Karla, Zibby, Clara and Adrianna are an absolutely amazing, hard-working group of dedicated women who really care about people suffering from RLS.

Q. What is your biggest piece of advice for those struggling with their RLS?

A. People are their own best experts; we can recognize when something is not right within our bodies. When you don’t get a satisfactory answer about a problem you are having, it doesn’t mean that your doctor does not care or that they are dismissing you. It may just be that they don’t know enough about RLS and may not realize what an impact it is having on your quality of life. If at first you see a clinician who does not quite understand what you are saying, it does not mean that all doctors do not know about it, it just means you need to keep looking until you find the right physician who does know about RLS. Sometimes that means doing a little bit of detective work. Most neurologists should know about RLS, and even if they are not experts, they may be able to refer you either to a movement disorder specialist within neurology or directly to a board-certified sleep physician at an accredited sleep center. Being your own advocate and not settling for the first answer that you get – just being true to your body – is my best piece of advice on RLS.

To view a list of healthcare providers organized by state who have come forward expressing an interest and knowledge in treating RLS or learn more about RLS Quality Care Centers, visit www.rls.org.

Board Spotlight: Dr. Christopher Earley

By Adrianna Colucci, RLS Foundation Administrative Assistant

Christopher J. Earley, MB, BCh, PhD, FRCPI, is both a professor of neurology at the renowned Johns Hopkins School of Medicine and the director of the Johns Hopkins Center for Restless Legs Syndrome, a certified RLS Quality Care Center in Baltimore. Among various other achievements, he is also chair of the RLS Foundation’s Scientific and Medical Advisory Board (SMAB). Dr. Earley’s devotion to neurology and sleep medicine for over 30 years has made him widely acclaimed, particularly for his research and expertise in managing RLS. His commitment was recognized in 2017 when he received the RLS Foundation’s prestigious Ekbom Award.

Q. When did you initially discover the RLS Foundation, and how did you become involved?

A. I believe the year was 1992. Dr. Art Walters, my colleague Dr. Richard Allen and I met with Pickett Guthrie in Washington, DC. This was right around the time Mrs. Guthrie formed the idea of establishing an RLS Foundation. By the time it was fully formed, I was an active member of the Scientific and Medical Advisory Board. I eventually became chair of the Scientific and Medical Advisory Board, and am currently in my fourth year and second term as chair.

Q. As chair of the Scientific and Medical Advisory Board, can you describe some of your responsibilities?

A. As chair, I primarily maintain an advisory role, assisting those who maintain the daily functions of the Foundation. I am responsible for the final review of any newly revised medical publications, alongside other members of the SMAB, as well as for suggesting new topics of clinical importance. More generally, I have oversight of ongoing initiatives within the SMAB, including communication with the RLS Foundation Brain Bank, reviewing grants and advising the Board on public health issues. I am actively involved in contributing to the educational components of the Foundation such as the monthly webinar series, the Virtual Summit, the National Patient Symposium and the Public Policy Initiative.

Q. Throughout your educational and professional achievements, what inspired your special interest in RLS research?

A. “Serendipitous” comes to mind. When I began working at Johns Hopkins, I was initially set to design and run the acute stroke program, which I did for numerous years. Part of my responsibilities included working in the sleep clinic where sleep research was in its earlier stages. About three years prior, carbidopa/levodopa had begun to be prescribed for RLS, so we were seeing many RLS patients with signs of augmentation. Some of the very first RLS patients I treated were augmented, so I became heavily involved with research relating to dopamine agonists and this side effect. We started to develop a reputation for treating RLS, and after about 10 years I became involved full-time with the sleep clinic. I am now the director of the certified RLS Quality Care Center at Johns Hopkins.

Q. What accomplishments or successes are you most proud of from your involvement with the SMAB?

A. One of the important accomplishments I’ve witnessed throughout my involvement is helping to establish an identity and a direction for the RLS Foundation. When Karla Dzienkowski became the executive director, she asked me to become chair of the SMAB. This was an opportunity to work with someone who was passionate about developing clear objectives and upholding the values of the Foundation. I am proud to have played a small role in successfully building and strengthening the organization, which is truly the only hope for some RLS patients.

Q. What are some of the established goals the SMAB has in the foreseeable future?

A. We would like to increase the availability of grants for those who are doing research in areas pertinent to what we believe contributes to the pathophysiology of RLS. I consider this one of my primary roles moving forward. The second goal we have set is to advance our educational outreach to a larger audience. It is imperative to reach not just the neurologists and sleep specialists, but also the primary care physicians to educate them on the clinical and scientific aspects of RLS. While we have made great strides, there is still more work to be done.

Q. Beyond RLS, you are also published in endocrinology and internal medicine. Do you find that your research intersects and if so, in what way?

A. My PhD was involved with the endocrine system, looking at behaviors and brain chemistry. My first eight to 10 years at Johns Hopkins included stroke research; however, my broadest interest was focused on sleep medicine – trying to get a more in-depth understanding of sleep-wake biology and clinical indications. There is great depth to sleep research and understanding the true biological nature of sleep, such as why we sleep and the value of sleep. The framework of RLS research exists within the framework of sleep biology. I am extremely proud of the progress made by many of our researchers on the RLS Foundation SMAB to unlock the mysteries of RLS and find better treatments.

Good Sleep Hygiene: More Than Just a Bedtime Routine

Sleep hygiene is always a sensitive subject when you have an underlying sleep condition that stops your sleep in its tracks. Sleep hygiene is not simply about crafting and sticking to a bedtime routine; sleep hygiene encompasses your daytime habits, in addition to your evening and nighttime habits. In this article, you will learn the science of how sleep works, the effects of poor sleep on overall health, how your internal circadian clock works and some helpful tips on how to achieve better sleep. This will give you some insight into the importance of maintaining and implementing a healthy sleep-wake schedule.

Studies have shown the tremendous complexity that is “sleep” and how it affects virtually all body systems. Lack of sleep in adults has been correlated to a broad range of negative health consequences that include cardiovascular problems, compromised immune function, insulin resistance, higher risk of obesity, cognitive dysfunction and mental health problems. Sleep is an essential biological function, and it is a time for your brain to restore and heal after a long day.

SLEEP ARCHITECTURE

When you first drift off to sleep, there are almost immediate changes in both the brain and the body. Your body temperature drops, brain activity goes down, your heart starts beating slower and your respiration slows.

There are four different sleep stages that you experience each night. The first three are categorized as non-rapid eye movement (non-REM) sleep, and the final stage is REM sleep. Stage one occurs just as we fall asleep. It is very light sleep and when woken up during this stage, most people will not be sure that they were actually asleep. Stage one sleep is what allows people with sleep apnea to take a breath again. When someone stays in stage one sleep, which is non-restorative sleep, they are often very sleepy in the daytime. This does not happen to people who have lots of stage two sleep.

When you transition into stage three, you experience some of your deepest sleep as your muscles relax and your brain activity slows. Researchers believe the recuperation of the body and brain happens at this time. Stage three sleep varies dramatically with age. Children may spend 30% of their sleep in stage three, while seniors may have little or no stage three sleep.

REM sleep is the fourth stage of sleep, lasting about 10–60 minutes in short episodes that increase in duration towards wake time. In REM sleep, activity in the brain and most of the body pick up significantly. The skeletal muscles experience temporary paralysis. The REM sleep stage is often believed to be critical for the brain, enabling important functions like learning and memory.

Sleep architecture is the structure of a person’s stages of sleep and cycles throughout a night. Each stage is essential to a person’s overall sleep architecture, which affects sleep quality.

THE MASTER CLOCK IN THE BRAIN: BREAKING DOWN CIRCADIAN RHYTHMS

Circadian rhythms are 24-hour cycles that coincide with the body’s internal clock, which executes essential functions and processes throughout the body. The most commonly known and important circadian rhythm is the sleep-wake cycle. The body’s master clock is directly impacted by the surrounding environment. This is why circadian rhythms are tied to the cycle of day and night.

The hypothalamus, a part of the brain, is home to the suprachiasmatic nucleus (SCN), which is highly sensitive to light and acts as a cue for brain signals to coordinate the internal clocks in the body. There are other cues that can affect the master clock, but light is the most powerful stimulus. During the daytime, exposure to light causes the master clock to send signals that generate alertness. As the day winds down, the master clock initiates the natural production in the brain of the hormone melatonin, which promotes sleep.

START SMALL AND WORK YOUR WAY UP

There are many ways to improve your sleep hygiene and cultivate healthier sleep. There is no one-size-fits-all approach. It is important to determine what works for you and implement tactics that fit your lifestyle. The Sleep Foundation has broken down sleep hygiene tips into four categories to make them more approachable.

1. Transform your bedroom environment:
• Choose a mattress and pillow that ensure your comfort and promote relaxation. Find a favorite pillow and comfortable mattress that will ensure a good night’s sleep.
• Get good quality bedding that is comfortable to the touch and will help you maintain a temperature comfortable to you throughout the night. Bedding such as a new mattress or pillow is key to promoting sleep. There are sheets and mattresses that have a cooling or warming effect.
• Reduce light disruption. A cool, dark, quiet environment is conducive to sleep. Blackout curtains can help achieve a darker environment. Earplugs and a sleep mask are other items that can help to limit light and sound in the bedroom.
• Keep noise to a minimum to elevate your sleeping. Try noise-canceling headphones, ear plugs, or machines or phone apps that create ambient noise (white, purple, rain, etc.).
• Decide an ideal room temperature, since being too hot or cold can distract you from a good night’s rest although it is known that people tend to sleep better in cooler environments.
2. Improve your sleep schedule:
• Try to go to sleep and wake up at the same time every day, even on weekends. It is nearly impossible to get accustomed to a sleep routine when you are waking up at different times. Consistency is vital to maintain healthy sleep and the wake time consistency is much more important than bedtime.
• Be wary of naps. If you nap for too long or too late in the day, there is a risk of disruption to your sleep schedule. If you enjoy a nap during the day, no worries! Try to nap after lunch in the early afternoon; it’s proven that a 20-minute nap is ideal. However, for patients with significant bedtime insomnia, napping should be discouraged.
3. Cultivate a bedtime routine:
• Don’t just jump into bed. Winding down for approximately 30 minutes can help you drift off to sleep with ease. Reading, stretching, listening to soothing music or doing relaxation exercises can help put your mind and body in the mood for a great night’s rest.
• Follow a set bedtime routine. Habitual actions are correlated to specific cues that tell your brain that you are almost ready for sleep.
• Turn down the lights. Bright lights can affect the production of melatonin in the body.
• Adjust devices, tablets, cell phones and laptops. These light- emitting devices can keep your brain awake. The more interactive the device, the bigger the impact on falling asleep. Keep the blue light down and change to orange/red light for 3 or more hours before bedtime. Most LCD screens (cell phones, computers) have a setting option to turn the light red and lower in the evening. It is recommended to disconnect at least 30 minutes prior to climbing in bed.
4. Create healthy habits during the day:
• Get daylight exposure. Natural light in the morning and early afternoon supports consistent and high-quality sleep by driving your circadian rhythm and aligning your sleep-wake pattern. For those unable to get outdoors, there is a bright light therapy box to simulate natural light.
• Try to incorporate movement into your daily routine. Activity promotes health across the board and can help make it easier to sleep at night. A short 20-minute walk can transform your day and help you get to sleep at night but don’t exercise too close to bedtime as that can hype your brain up.
• Reduce the amount of caffeine you consume after lunchtime. Caffeine can take up to seven hours to be fully out of your system.
• Plan mealtimes. It is best to avoid heavy meals two to three hours before bedtime to avoid still digesting when getting ready for bed.
• Reduce alcohol consumption in the evening. Alcohol can make it easier to fall asleep but has been shown to disrupt sleep later in the night when you are in the important stages of REM sleep. Also, avoid caffeinated beverages too close to bedtime.
• To cultivate a healthy relationship with sleep, try to limit the activities in bed to sleeping and sex only.

TIPS FOR WHEN YOU CAN’T FALL ASLEEP

Whether you have just crawled into bed or woken up in the middle of the night, here are some tips to help you fall asleep: 1. Don’t toss and turn in bed in the hopes of getting to sleep. This can create a connection in your brain between frustration and your bed. Try walking around for a couple of minutes, reading in low light, or doing something relaxing or very boring before returning to bed when you feel sleepy. 2. Avoid checking the time. Constantly checking the time can increase anxiety about sleeping and in turn make it harder to fall back asleep. 3. Record your sleep. A sleep log or journal can help identify patterns that may be hindering your sleep. If you are implementing new sleep hygiene tactics, track the changes and see how well they are working for you. A sleep diary may help your doctor get a better idea of your day-to-day habits and a clearer picture of your sleep.

To benefit from these sleep tips, it is essential to incorporate them into your daily life. It can be overwhelming to completely restructure your relationship with sleep. Start small and work your way up. Stick with your changes. You may not see the benefits right away, and that’s okay. Maintaining your plan may very well pay off over time.

Life happens, so you may not be able to follow your curated routine every single day. Give yourself some grace and set realistic expectations that are attainable for you!

Sweet dreams.

Should Cannabis be Considered an RLS Treatment?

Research examining the potential role that medical cannabis can play in treating medical conditions and sleep disorders is increasing within the United States. Cannabis is a plant containing active ingredients that is classified as a psychoactive drug when ingested, inhaled, or applied.1 Under federal legislation, cannabis is illegal and defined as a Schedule I drug: however, states have individual laws regarding its recreational and medical use. While medical marijuana is not among the approved treatments for RLS, there are individuals who have anecdotally had success in managing symptoms using the drug with or without the supervision of their healthcare providers.

WHAT IS CANNABIS?

Over 450 chemical compounds have been identified in cannabis. The two most commonly referred to compounds, or cannabinoids, are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The human body produces endocannabinoids naturally as an important part of regulating the circadian sleep cycle and maintaining homeostasis, a state of balance among biological systems in the body.2 These endocannabinoids bind to cannabinoid receptors in the body, primarily CB1 and CB2 receptors. These are found predominantly in the central and peripheral nervous systems and in immune tissues.1 When THC or CBD are introduced to the body, these cannabinoids interact with the endocannabinoid receptors differently, producing distinct reactions.

DIFFERENCES IN CLASSIFICATIONS OF CANNABIS

THC is the main psychoactive component in marijuana and interacts primarily with the brain’s CB1 receptors, eliciting a euphoric or “high” sensation. THC can be used medicinally to prevent nausea that occurs in chemotherapy patients, promote appetite and can help treat certain medical conditions. Some of the adverse effects include short-term memory loss, increased heart rate, loss of coordination, and hallucinations. Longer term, there is a risk of addiction, along with impaired cognition and brain development.

CBD does not produce the same euphoric feeling as THC. How CBD interacts with cannabinoid receptors is not well understood, but studies suggest it can provide relief from anxiety or pain. There are no significant neurological effects associated with CBD, and it can help increase sedation to help insomnia. Some of the adverse effects include decreased appetite, fatigue, drowsiness and an increased risk of infection.2

CANNABIS AND SLEEP

A study conducted in 2017 looked at the effectiveness of medical cannabis as a substitution for pharmaceutical options for pain, anxiety and sleep.3 Of the 1,513 participants who took part in the survey, 76.7% indicated the ability to reduce their regularly prescribed opioids after incorporating medical cannabis into their management plan. Furthermore, 65.2% reduced their sleep medications. Other studies show that administration of THC is beneficial on a short-term basis, but developing tolerance and withdrawal can eventually cause sleep disturbances.

Although drowsiness is a side effect of CBD, findings vary on its effectiveness for treating sleep disorders. CBD was used in a large case study that observed its efficacy in a group of 72 adults presenting with anxiety, of which 25 suffered from inadequate sleep.4 Most patients were prescribed 25 milligrams, although those with severe cases were prescribed 50-75 milligrams. For those with anxiety, the capsule was administered early in the day, and for those with sleep concerns, it was given in the evening. Sleep quality was documented according to the Pittsburgh Sleep Quality Index. In the first month, the quality of sleep improved in 66.7% of participants, while 25% experienced worsening sleep issues. These numbers fluctuated in the following month when only 56.1% reported an improvement in sleep and 26.8% reported worsening problems. Though sleep scores demonstrated a mild improvement, CBD showed a more consistent benefit for anxiety than with sleep issues.

CANNABIS AND RLS

There are very few academic studies that investigate the correlation between RLS and the effects of medical cannabis directly. Observational data published in 2020 by Dr. Imad Ghorayeb examined twelve predominantly male RLS patients, ages 31 to 69.5 Eleven of the twelve participants reported an improvement in RLS symptoms after smoking cannabis or using CBD oil in addition to their current treatment medications. These improvements ranged from 60% to 100%, with the last participant noting no improvement. Due to concern about psychoactive effects and the potential risk for abuse, three of the individuals switched to CBD oil, noting the increased effectiveness of smoking cannabis versus a topical treatment. This data shows the need for further clinical trials and research on the efficacy of cannabis and CBD.

The observations of one of the RLS experts based in California, where marijuana has been legal and widely used for many years, is that inhaled marijuana most often relieves RLS symptoms after only 1-3 inhalations. This effect typically onsets within less than 5 minutes but only lasts 1-2 hours. Edible marijuana, even in high doses is rarely effective in relieving RLS symptoms. CBD may sometimes promote sleep but does not improve RLS symptoms.

CONCLUSION

Cannabis has been cultivated by numerous cultures, spanning centuries for its medicinal properties. Based on a lack of clinical data, further research is required before cannabis can be recommended for routine use for RLS. If you are thinking of integrating cannabis into your treatment, be sure to consult your doctor, as it can interact with other drugs. There are various forms of cannabis available including vapor, smoke, edibles, plant resin and oil extracts. Consult with your physician to determine which method and dosage may be right for you.

SOURCES:

1 Kaul M, Zee PC, Sahni AS. “Effects of Cannabinoids on Sleep and their Therapeutic Potential for Sleep Disorders.” Neurotherapeutics. 2021 Jan;18(1):217-227. Doi: 10.1007/s13311-021-01013-w. Epub 2021 Feb 12.

2 Bainbridge, Jacqueline Pharm D. FCCP, MSCS, FAES. “Medical Marijuana/ Cannabis: The Proof is in the Pudding” Webinar. 2022.

3 Piper BJ, DeKeuster RM, Beals ML, Cobb CM, Burchman CA, Perkinson L, Lynn ST, Nichols SD, Abess AT. “Substitution of medical cannabis for pharmaceutical agents for pain, anxiety, and sleep.” J Psychopharmacol. 2017 May;31(5):569-575. doi: 10.1177/0269881117699616. Epub 2017 Apr 1 PMID: 28372506.

4 Shannon S, Lewis N, Lee H, Hughes S. “Cannabidiol in Anxiety and Sleep: A Large Case Series.” Perm J. 2019;23:18-041. doi: 10.7812/TPP/18-041. PMID: 30624194; PMCID: PMC6326553.

5 Ghorayeb I. “More evidence of cannabis efficacy in restless legs syndrome.” Sleep Breath. 2020 Mar;24(1):277-279. doi: 10.1007/s11325-019-01978-1. Epub 2019 Dec 9. PMID: 31820197.

The ‘Opioid Issue’ Still Needs Your Attention

Five years ago, we wrote in NightWalkers about the challenges that people with RLS and their doctors face in getting opioid prescriptions filled. In recognition of the seriousness of the problem experienced by many of our members, we retained the services of a public affairs firm in Washington that specializes in healthcare issues to help us alert policymakers about the problem and to craft sensible federal policies that recognize the unique role these medications play in providing relief for many among us.

In response to concerns about opioid addiction, the Foundation has funded groundbreaking research that documents the long-term safety and efficacy of opioids as a treatment for severe RLS.

Over the intervening years, we have deployed Foundation staff, members of our Scientific and Medical Advisory Board, and individual Foundation members to visit members of Congress, federal agencies, and others making or influencing policy, legislation or regulation on this topic.

Nevertheless, those who write the guidelines and rules about dispensing opioids continue to get it wrong: They craft guidelines appropriate for treatment of chronic pain that lack recognition of the unique neuropathology of RLS and the specialized consideration required in treating RLS, but rather include RLS in the category of generalized pain issues.

Documentation can be found in medical literature as far back as four centuries ago about the safety and efficacy of low total daily doses of opioids to treat people with severe RLS that has failed to respond to other treatments. This so-called “off-label” use is relatively common when physicians discover that drugs can alleviate conditions beyond those specifically approved by the government. (For example, a medication approved for high blood pressure is frequently prescribed to musicians to prevent performance anxiety.) To obtain approval “on label,” the government requires extensive, costly years of testing.

Pharmaceutical companies are unwilling to invest in such lengthy trials, particularly in the case of drugs like common opioids that cannot be patented. With no hope of recapturing the costs of testing a drug, no company will undertake the licensing process.

To be sure, there are approved drugs that are useful in treating RLS symptoms. These include alpha-2-delta ligands (gabapentin-type drugs, originally developed to treat seizure disorders and nerve pain), iron infusion, and dopaminergic drugs such as pramipexole, ropinirole, rotigotine and levodopa/carbidopa.

Unfortunately, experience has shown that while dopamine agents improve symptoms over the short term, over time, they can make RLS worse. This is an untoward effect of dopamine therapy known as augmentation, in which the medication prescribed to treat RLS symptoms actually makes the disease worse over months or years. Thus, dopamine drugs are no longer favored for long-term use.

When all other options have failed, as they do for many people with RLS, there is only one remaining treatment available: opioids.

The Centers for Disease Control and Prevention (CDC) has recently published a revised guideline for the use of opioids to treat chronic pain. The new rules are similar in many respects to prior versions, except that they reduce the maximum recommended daily dose of opioids to an even lower level than before.

Available information indicates that three-fourths of RLS patients using opioids are prescribed doses below these new CDC guidance levels. Alarmingly, this means that about one-fourth of patients receiving opioids are at risk of losing access to the only effective treatment for their disease.

It appears that the new guidelines ignore well-established scientific evidence that RLS is different from chronic pain and needs to be treated differently. Consider the following facts:

• In contrast to chronic pain, where opioids lose their effectiveness over time, when used to treat RLS, the drugs continue to provide relief from RLS symptoms for years, even decades.
• When prescribed for chronic pain, patients must increase doses over time to achieve relief. In contrast, The RLS Opioid Registry, a longitudinal study conducted at Massachusetts General Hospital, has found RLS patients remain at low total daily doses for decades; no increases are required to sustain relief.
• RLS patients typically do not develop opioid use disorder or develop issues of tolerance or dependence. Research and expert opinion have found that the low total daily doses used to manage severe RLS do not lead to tolerance or dependency issues, which are hallmarks of opioid use disorder.

To be fair, the revised CDC guideline recognizes that it is only advisory, not mandatory. “This clinical practice guideline provides recommendations but does not replace clinical judgment and individualized, patient-centered decision-making.”

Unfortunately, experience demonstrates that such language is widely ignored. Suggestions are transmuted into hard and fast rules. The Foundation receives reports from members and physicians that state regulators have converted this guideline into rigid regulations, insurance companies have refused to provide coverage for opioids even when within the recommended limits, pharmacies have refused to fill legal and proper prescriptions for opioids for RLS, hospital emergency rooms have treated patients using opioids for RLS control as if they were addicts and criminal drug dealers, and some doctors, clinical practices and medical centers have stopped prescribing opioids at all treat RLS. Even worse is the letter patients receive that their physician no longer treats RLS and they will need to find a new provider. These reactions are driven by fear, not science.

It is notable that the new guideline acknowledges that the general advice the CDC provides on opioids specifically does not apply to three situations: patients with sickle cell anemia, cancer patients with pain, and palliative care (end-of-life) treatments. We believe that the CDC needs to add RLS to the list of medical conditions that lie outside of its recommendations for the treatment of chronic pain.

How is the Foundation responding to this challenge facing its members? We have already held conversations with the leadership at the CDC. We note that:

• RLS is a distinct neurological condition that responds differently to opioids than chronic pain.
• RLS is a very significant disorder with a greater disruption in health-related quality of life than many other recognized medical conditions.
• There is a four times greater risk of suicide among those with severe RLS than in the general population, and twice the risk than that of people with severe chronic pain.
• There is strong evidence that using opioids to treat RLS does not lead to tolerance or dependence on opioids.
• Most of the drugs approved by the Food and Drug Administration to treat RLS (Requip, Mirapex and Neupro) actually make the condition worse over time, and the remaining approved drug (Horizant) is either not tolerated or is not fully effective in a large percentage of people with severe RLS.
• The CDC should specifically exempt RLS from the guideline for opioid prescribing in the same way that it has exempted sickle cell disease. Like sickle cell disease, RLS is a disease with a genetic predisposition.

The RLS Foundation hopes that the CDC will respond to these arguments. If it does not, we expect that we will need to carry the same discussion to other venues that are involved in the process, up to and including the United States Congress.

We will keep members of the RLS Foundation advised of our progress. It is possible that we will ask members to add their voices to the more than 500 members of the Foundation who have already submitted comments to the CDC during the public comment period preceding the issuance of the new opioid guideline (more than 10% of all comments listed). Although we did not achieve the hoped-for goal in that process, it is clear that there is more work to be done. Please be alert to calls for action.

Our efforts to fight for the rights of those with RLS to obtain the medical treatment they need and deserve, without undue restrictions, are ongoing. The RLS Foundation is a volunteer-driven organization, and we appreciate your continued financial support to increase our advocacy efforts. For more information on how you can get involved, go to www.rls.org/advocacy.

Help! I Think I Have Augmentation and Don’t Know What to Do!

Each day at the RLS Foundation we receive calls from individuals seeking support, information and help with augmentation, a distressing challenge to their RLS treatment.

The good news is that, thanks to ongoing research, augmentation is manageable and treatment options are available. This article provides an overview of augmentation that will help you to understand this unfortunate side effect of treatment and the available strategies to manage it.

What is Augmentation?

Augmentation is a worsening of RLS symptoms that occurs after starting a medication that increases dopamine levels in the brain. These dopaminergic medications include levodopa/carbidopa, ropinirole, pramipexole and the rotigotine patch. At first, medications in this category are very effective, but over time, in a period from six months to several years, RLS symptoms worsen from what they were prior to initiating therapy. The rate of augmentation in people taking dopamine drugs for RLS is 5%- 10% per year; in eight years nearly half of individuals taking dopaminergic medication will experience augmentation.

If an individual with RLS notices symptoms progressively worsening after starting treatment with a dopaminergic drug, then augmentation may be occurring. Simply put, the treatment initially prescribed to alleviate symptoms is worsening the disease.

What are the Symptoms of Augmentation?

Augmentation is an insidious process, and symptoms often go unnoticed. The first indication of an underlying problem is when a patient feels the need to request an increase in medication dose.

All individuals with RLS should recognize the symptoms of augmentation, which include:

• Earlier onset of symptoms, beginning in the afternoon and evening, rather than at bedtime
• Increase in the intensity of symptoms compared to their level prior to starting treatment
• Spread of symptoms to other body parts (trunk, arms or face), rather than being limited solely to the legs
• Shorter period of rest or inactivity before symptoms begin, and treatment medication is not working as long as it did previously
• Loss of effectiveness of the medication at the dose that previously managed symptoms
• Paradoxical response to the medication; in other words, the prescribed medication triggers symptoms rather than alleviating them

Three factors predispose an individual with RLS to developing augmentation:

• Daily administration of carbidopa/levodopa to treat RLS
• Exceeding the maximum dosages approved by the Food and Drug Administration (FDA) for dopaminergic drugs used to treat RLS
• Low body iron stores as measured by a laboratory test of serum ferritin

When someone is experiencing augmentation, aggressive iron supplementation is extremely important. Intravenous formulations effective in raising blood iron storage levels in RLS patients include: Ferumoxytol (Feraheme); low molecular iron dextran (INFeD); ferric derisomaltose (Monoferric) and ferric carboxymaltose (Injectafer). Ferrous sulfate 365 mg pills taken once daily can be used for ferritin levels higher than 75–100 mcg/L or transferrin saturation less than 20%. However, RLS patients with deteriorating symptoms need rapid iron repletion, and oral iron takes months to improve iron status.

If you, as a patient, suspect augmentation, the first course of action is to make an appointment with your healthcare provider; do not stop taking the medications, as prescribed, to manage your RLS.

How is Augmentation Diagnosed?

Before a diagnosis of augmentation can be made, the first step is to schedule an appointment with your RLS healthcare provider for a thorough medical examination to rule out any underlying medical conditions that can exacerbate RLS symptoms. Two additional aspects of RLS that are often confused with augmentation are night-to-night variability of symptoms and exacerbation of symptoms for several days; neither is indicative of augmentation.

Factors that can worsen RLS include the use of sedating antihistamines; all antidepressants except for bupropion or trazadone; low body iron stores or unexpected blood loss due to surgery or undiagnosed gastrointestinal bleeding (ulcers, polyps); commonly reported triggers of symptoms such as caffeine, alcohol, sugar, salt or nicotine; a secondary undiagnosed sleep disorder such as sleep apnea; or rebound (the prescribed medication is not lasting as long as it did previously and disrupts sleep at the end of the sleep cycle in the early morning hours). Two additional factors that can cause an increase in RLS symptoms are stress and changes in activity level, such as immobility due to surgery or changes in exercise, activity or routines.

Augmentation Diagnosis: What’s Next?

RLS is a chronic progressive disease, and it is often difficult to distinguish between disease progression (natural worsening of the disease) and augmentation. Healthcare providers need to be aware of the key indicators of augmentation, which include:

• The patient requests a dose increase of a dopaminergic medication.
• The prescribed dose currently exceeds FDA maximums for the dopaminergic medication.
• The patient reports breakthrough RLS symptoms with an accompanying increase in symptom intensity.
• The RLS involves other body parts (trunk, arms, face).
• Symptoms occur 24/7.
• Symptoms previously appearing only in the evening or nighttime now present earlier in the day, and the patient requests additional medication doses earlier in the day.

There is no test for the diagnosis of RLS augmentation. A thorough medical examination by your healthcare provider who reviews current medications (over-the-counter medications, supplements, prescriptions) to look for drugs that can worsen RLS symptoms, along with a comprehensive history of symptom progression, will help to determine if augmentation is present.

How is Augmentation Managed?

There are four treatment strategies to manage RLS augmentation. Working with your doctor you can determine the approach that best works for you.

The first approach involves changing the dosing schedule to “split-dose” the dopaminergic medication. Half the dose of the medication is given earlier in the day, and the second half is given at the regularly scheduled time; the total dose is not to exceed FDA maximums. If this approach does not resolve symptoms, a second medication from another medication class is added to the treatment regimen. Alpha-2-delta ligand drugs such as gabapentin, gabapentin enacarbil, and pregabalin are added to the treatment plan while reducing the dose of the dopaminergic agent. This approach may be effective, but the alpha-2-delta ligands may not be sufficient to control RLS symptoms in the absence of the dopaminergic agents.

A second treatment option to manage augmentation is to switch from a short-acting dopamine agonist to a long-acting one, but this approach is not recommended by RLS experts. The FDA approved the Neupro (rotigotine) patch for the treatment of RLS, and the oral medications pramipexole ER and ropinirole XL are also available. There are no studies to determine if the change to a long-acting dopamine agonist will reduce or mask RLS symptoms. RLS experts have found that tapering off long- acting dopamine agonists with preexisting augmentation is considerably more difficult. Although symptoms improve in the short term, the underlying augmentation remains, and in time symptoms will return.

The third approach involves adding an opioid medication such as buprenorphine, suboxone, methadone or oxycodone to the dopamine agonist, then tapering down the dopamine agonist. Once the transition from dopamine agonist to opioids has occurred, the dose of the opioid is reduced. If symptoms persist, an alpha-2-delta ligand can be added to the treatment protocol, or it can be used to decrease the dose of opioid used.

The final approach to address augmentation is to slowly decrease the dose of the dopamine medication, without any other RLS treatment, followed by 12 drug-free nights before reassessing the need for further treatment. The RLS Foundation handout Drug Holidays and RLS provides a thorough outline of this approach to the treatment of augmentation.

For patients with severe augmentation who have taken high dopamine medication doses, it may be difficult to completely eliminate these drugs, due to the worsening of RLS upon withdrawal. A small dose of a dopamine drug in combination with an alpha-2-delta ligand and/or opioid may be necessary to manage symptoms. However, it is important to note that, once a dopamine drug is successfully discontinued, reintroducing any drug in the dopamine class will lead to a rapid reappearance of augmentation. In other words, all drugs in the dopamine class are no longer a treatment option.

How Do I Find a Provider to Manage RLS Augmentation?

A provider who is knowledgeable and experienced in treating RLS can be found at an RLS Foundation Quality Care Center. The doctors who practice at these centers are certified RLS providers who treat patients with augmentation and are familiar with the available treatment options. There are 10 RLS Foundation Quality Care Centers in the United States and two in Europe; travel to receive expert care is an option available to individuals with RLS, though not all patients can afford to do so. For a list of RLS Foundation Quality Care Centers, visit www.rls.org/QCC or contact the Foundation.

A second option is to work with the healthcare provider managing your RLS treatment. You will want to determine that they have experience in managing augmentation and are willing to work with you through the entire process. Finding a treatment plan to manage your RLS augmentation is not a one- size-fits-all approach, so finding a provider who is willing to work with you is essential.

The RLS Foundation maintains a list of providers who have expressed an interest in treating RLS, and this may be an option for you. To view this list, visit www.rls.org/Find-a-doc or contact the Foundation. However, these healthcare providers are not certified RLS experts like those practicing at an RLS Quality Care Center.

I Think I Have Augmentation. What Can I Do to Help Myself?

You can do several things before an appointment with your healthcare provider that will give them insight into the state of your RLS. Below is a helpful checklist of items to prepare you for your appointment:

1. Resist the urge to make any changes to your current treatment plan. Your healthcare provider needs to get a clear picture of your RLS symptoms under your current treatment plan; any changes could make this more difficult.
2. Schedule an appointment with your healthcare provider as soon as possible. Because scheduling delays are common, ask whether your name can be added to a cancellation list when you book your appointment. That way, if there is a cancellation, you may be called to fill the slot in the schedule.
3. Make a list of all medications that you currently take (prescriptions, over-the-counter medications, supplements).
4. Make a chronological list of all medications that you have taken in the past for RLS and note why you stopped taking them.
5. Gather copies of all laboratory test results for iron, and any other recent laboratory test results for your provider to review.
6. Complete an RLS Sleep Diary, included in this issue of NightWalkers. The Sleep Diary will provide your healthcare provider with an overview of your sleep patterns and RLS symptoms.
7. Make and bring copies of the following open-access articles from Mayo Clinic Proceedings: “The Management of Restless Legs Syndrome: An Updated Algorithm” (2021) and “The Appropriate Use of Opioids in the Treatment of Refractory Restless Legs Syndrome” (2018). For copies of these articles, visit www.mayoclinicproceedings.org or contact the Foundation.

For more information about augmentation and RLS, visit the RLS Foundation’s Member Portal on www.rls.org to find educational resource materials. We invite you to attend the Foundation’s monthly webinar series presented by RLS experts and to watch past webinars online to become more knowledgeable about RLS. The Foundation also sponsors four monthly online Virtual Support Group Meetings, so you can connect with others in the RLS community for support, tips and helpful information.