Restless Legs Syndrome Foundation Blog

RLS Community: Provide Your Comments to CDC by April 10

Background

The Centers for Disease Control and Prevention’s (CDC) National Center for Injury Prevention and Control is in the process of updating the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. The draft updated Clinical Practice Guideline for Prescribing Opioids is available for public comment in the Federal Register until April 10, 2022. The RLS Foundation urges all RLS community members to add their voice to request that the CDC include chronic diseases like RLS in the treatment guidelines. Below are the 5 steps you can take to let the CDC know that low-total-daily dose opioids must be included as a viable treatment option for RLS patients.

Instructions

1. Start on webpage: https://www.regulations.gov/document/CDC-2022-0024-0001/comment and click on "Comment"

2. Enter your comment using the sample comment below as a template.

3. Identify yourself as an individual, 4. Check the box for reCAPTCHA, and 5. Submit Comment.

Thank you for joining our RLS advocacy efforts by raising your voice for RLS, sleep and sleep disorders!

-----*SAMPLE COMMENT*-----

I thank you for revising the CDC Clinical Practice Opioid Prescribing Guideline, but the draft does not address chronic conditions like RLS that are different from chronic pain. Restless legs syndrome (RLS) is a chronic neurological disease that causes an urgent need to move the legs and, in some cases, other parts of the body as well. The symptoms make it impossible to sleep or even to sit quietly, which seriously affects every aspect of daily life.

In the U.S., nearly 12 million adults and children suffer from RLS. There is no cure. A few prescription medications may relieve the symptoms for a while, but over time those same medications can make the symptoms worse. When all other medical therapies fail, ample scientific research supports the use of low-total-daily-dose opioids to treat severe RLS.

[Tell your own experience with RLS in a short paragraph.]

The first physician to diagnose RLS more than 300 years ago treated it successfully with opioid therapy. Ironically, the 2016 CDC Opioid Prescribing Guidelines often made physicians afraid to prescribe opioids for any reason, even for patients with severe, unrelenting RLS who had been on the same low-total-daily-dose opioid therapy for decades. I urge the CDC to include a section in the 2022 Opioid Prescribing guidelines to address chronic medical conditions like RLS that require opioid therapy as a last resort, in low-total-daily doses, carefully monitored.

Thank you for your consideration of these vital issues, and please consider the RLS Foundation at www.rls.org as a resource for scientifically-based information about RLS, as it is for members like me.

Act NOW!

Add your comments by April 10 to be sure that the committee receives as many comments as possible from the RLS community. Please contact the RLS Foundation for assistance at info@rls.org.

RLS Foundation Certifies UPMC as Quality Care Center

The Restless Legs Syndrome (RLS) Foundation announces it has certified the University of Pittsburgh Medical Center (UPMC) in Pittsburgh as an RLS Quality Care Center.

As an RLS Quality Care Center, the University of Pittsburgh Medical Center is certified to provide expert care to patients who have restless legs syndrome, a chronic neurological sleep disorder.

An estimated 2% to 3% of adults need daily clinical treatment for RLS, a chronic neurological disease that disrupts sleep and can have a devastating impact on quality of life. As an RLS Quality Care Center, UPMC will serve as a destination for RLS patients who need expert medical care.

“We are honored to receive this designation,” says Avinash Aggarwal, MD, director of the Quality Care Center at UPMC. “Our goal is to provide the best and most comprehensive care for patients who have RLS. Designation as an RLS Quality Care Center certifies that we adhere to the highest standards of care and will identify us as having expertise to treat RLS at all levels of severity. We are particularly proud to be the first in our region to receive this designation.”

UPMC joins a network of 11 institutions in the US and Europe that are certified by the RLS Foundation as Quality Care Centers. Through this program, the Foundation aims to improve diagnosis and treatment of the disease worldwide.

RLS Quality Care Centers:

• Provide expert care to RLS patients
• Serve as information and referral resources for regional support groups and for healthcare providers who treat patients with RLS
• Support patients and families through educational offerings and literature
• Share information with other centers to improve clinical best practices
• Partner with the RLS Foundation on quality improvement projects to raise the standard of care for RLS patients everywhere

“We are pleased to welcome UPMC into the Quality Care Center network,” says RLS Foundation Executive Director Karla Dzienkowski. “People with moderate to severe RLS face many challenges in managing their symptoms. Having access to healthcare providers who are highly skilled and experienced in treating RLS is essential for patients to get adequate treatment and improve their quality of life.” Dzienkowski adds, “Our goal is to help RLS patients find healthcare providers with expertise in disease management at a Quality Care Center. We look forward to our work in partnership with UPMC to advance the quality of care for RLS patients.”

Other certified RLS Quality Care Centers are:

• Johns Hopkins Center for Restless Legs Syndrome
• Mayo Clinic Center for Sleep Medicine
• Houston Methodist Neurological Institute
• Stanford Sleep Medicine Center
• Emory Sleep Center
• Yale Center for Restless Legs Syndrome
• Vanderbilt University Medical Center
• Scripps Clinic Viterbi Family Sleep Center
• Neurocenter of Southern Switzerland
• Innsbruck Medical University

To learn more about the RLS Quality Care Center Program, visit www.rls.org/quality-care-program.

RLS Foundation Funded Opioid Registry Finds COVID-19 Effect

The RLS Foundation is pleased to announce the publication of the article “Restless Legs Syndrome Severity in the National RLS Opioid Registry During the COVID-19 Pandemic” in the online January 2022 edition of Sleep Medicine.

The National Opioid Registry, funded by the RLS Foundation, is a longitudinal study to evaluate the use of an opioid medication in the treatment of refractory RLS.

The first of its kind, the study evaluates the impact of COVID-19 on RLS severity in this population. An increase in RLS symptom severity was found in this group during the early stages of the pandemic. The study highlights the need for clinicians to monitor and manage changes in patients' RLS symptoms during times of uncertainty with global impacts.

Free access to the article with no signup or registration required is available until March 26, 2022 here:

https://authors.elsevier.com/a/1eXMt4y2Nr15Bu

NIH releases the 2021 Sleep Research Plan

The Sleep Research and Sleep Disorders Research Advisory Board is congressionally mandated to develop the US Sleep Research Plan every five years. Established in 1993 by the US Congress, the National Center on Sleep Disorders Research (NCSDR) is part of the National Heart, Lung and Blood Institute (NHLBI), whose focus is to study the toll that sleep disorders and sleep loss have on productivity, longevity, illness, and mortality. The Sleep Disorders Research Advisory Board (SDRAB), which is an advisory board to the National Institutes of Health and National Sleep Center is responsible for writing the Sleep Research Plan.

RLS Foundation Board Member and SDRAB Member, Linda Secretan, was directly involved with writing the 2021 Sleep Research Plan. She helped to determine the plan’s key strategic goals and priorities.

The plan comprises five specific goals:

1. Sleep and Circadian Mechanisms Underlying Health and Disease
2. Risk Reduction and Treatment of Sleep and Circadian Disorders
3. Clinical Implementation of Sleep and Circadian Research
4. Sleep and Circadian Disruptions and Health Disparities
5. Foster the Development of a Strong and Diverse Workforce for Sleep and Circadian Research

These five goals provide opportunities for research in sleep and circadian rhythms but also encourage research into other areas of interest in the field of sleep. Secretan’s input helped shape the final plan, which includes nine critical opportunities that seek to expand research in the science of circadian and sleep research.

Sufficient sleep is an essential requirement for overall health and wellbeing, yet half of all US adults and three-quarters of teens report sleep deficiency – factors that impair sleep quality, sleep quality, and total sleep time. The 2021 Sleep Research Plan is a comprehensive document that highlights the importance of sleep and personal strategies to ensure restorative sleep. The plan also underscores the importance of sleep in overall health maintenance and disease prevention.

Sleep is an essential pillar to health maintenance just as diet and exercise. However, sleep is often the pillar given the least attention in health promotion activities. Yet, all three pillars need equal attention for optimum health and disease prevention.

The 2021 Sleep Research Plan will advance the science of sleep and circadian research leading to better patient outcomes for those living with sleep disorders.

A special note of thanks to the over 200 RLS community members who attended the Virtual Congressional Briefing on Tuesday, January 25, 2022, to announce the 2021 Sleep Research Plan.

Call for RLS 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. Additionally, grant applications may be supported for a total of 2 years, including a 1-time competitive renewal, for a total of up to $100,000 (including 8% for F&A costs). However, funding for the 2nd year will be contingent on progress reports that must be submitted 6 months and 12 months from the grant starting date, together with a funding request and an application for the 2nd year.

Spring 2022 Priorities

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

• Neurobiological interaction: Elucidate the points of interaction between RLS-relevant neuro-transmitters and neuropathways and iron deficiency
• Therapeutic responsiveness: Elucidate genetic, epigenetic, biologic, phenotypic and other predictors of responders to pharmacologic and IV iron therapeutics; including predictors of augmentation;
• 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.

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 March 4, 2022 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 to be submitted online here no later than March 4, 2022.

Applicants will be informed within 6 weeks of the deadline 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.

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 48 grants totalling nearly $2 million. Funding is provided by generous individual donors. We thank all of the donors this month giving in memory of Robert H. (Bob) Waterman, Jr. who was responsible for spearheading the RLS Research Grant Program in 1997. Help us to continue to fund promising new RLS research.

Nighttime Agitation — Is It RLS?

By Kathy Richards, PhD, RN, FAAN; member of the RLS Foundation’s Scientific and Medical Advisory Board

For people in the dementia stage of Alzheimer’s disease (AD-D), the problem of nighttime agitation, defined as the presence or worsening of behaviors such as aggression or wandering in the afternoon or evening, is a management challenge for their caregivers. This problem often leads to more and more restrictive living environments for persons with AD-D, including placement in nursing homes. In addition to AD-D, nighttime agitation might be a manifestation of a common neurologic condition: restless legs syndrome (RLS). Symptoms of RLS match those of nighttime agitation – that is, not being able to remain still, and experiencing symptoms in the evening.

In a recent study published in the Journal of Post-Acute and Long-Term Care Medicine, the characteristics and behaviors of 76 older adults with AD-D, nighttime agitation, and newly diagnosed RLS were measured. RLS was diagnosed using the Behavioral Indicators Test – Restless Legs, a validated tool for diagnosis of RLS in persons with AD-D. The individuals in the study were unable to cognitively and verbally report their RLS symptoms. The older adults with AD-D were also observed for nighttime agitation behaviors. Assessment of iron status and sleep quality (using motion sensors) was conducted for these patients as well. The researchers found that fewer minutes of documented sleep and lower transferrin (iron) saturation were associated with more frequent behaviors of nighttime agitation. Over three-quarters of the patients with RLS and nighttime agitation had been prescribed medications that worsen RLS, such as antihistamines and serotonin reuptake inhibitors.

These findings support clinical consideration of nighttime agitation as a sign of RLS and highlight the need for further research to identify new management strategies. The findings also suggest that medical providers should take steps to identify and diagnose RLS; treat iron deficiency anemia if indicated by low transferrin saturation; and deprescribe medications that worsen RLS. The combination of these strategies will lead to a reduction in any RLS component of nighttime agitation in patients with AD-D. In addition, it is recommended that nursing homes change common practices that are likely to worsen RLS discomfort and nighttime agitation, such as restricting residents from evening walking and putting them to bed early.

Kathy Richards, PhD, RN, FAAN, is a research professor at The University of Texas at Austin, School of Nursing. As a UT Austin PhD graduate, Kathy has conducted sleep research in Alzheimer's disease for 20 years, and received over $25 million in NIH funding to support her research endeavors. Her recent project is the NightRest project and the Behavioral Indicators Test for Restless Legs Syndrome in older adults. In partnership with Christine Kovach, PhD, RN, FAAN, Richards received a $3.9 million five year grant from the National Institute on Aging to improve the treatment of nighttime agitation in those with Alzheimer's disease. They hypothesize that RLS may be a cause for nighttime agitation and sleep disturbance in these individuals. This study marks the very first time that a new diagnostic tool will be used in research on nighttime agitation.

The RLS community has lost a giant with the recent passing of Robert H. Waterman, Jr. His career as a management consultant and Senior Partner with McKinsey & Co. culminated with the publication of the first “blockbuster” book on sound management practices. In Search of Excellence, co-authored by Bob and his McKinsey partner, Tom Peters, rose to the top of the New York Times Best Seller List, and changed the way business leaders around the globe thought about their roles as heads of successful companies.

Like many individuals who have served on the Board of Directors of the RLS Foundation, Bob was afflicted by the disease - so much so that it disrupted his career as a Senior Partner at McKinsey and led him to a path as an independent management consultant with The Waterman Group. It also led him to more than two decades of leadership at the RLS Foundation.

Bob served as Chair of the Board of Directors for six years (1999-2005) and later as Chair Emeritus (2010-2019).

Bob brought his insights, along with his passion for excellence, to the RLS community. He was a strong proponent of strategic planning and led the strategic planning initiatives for the RLSF Board for many years. He believed in setting BHAGs — Big Hairy Audacious Goals — and in that vein articulated basic strategic goals that remain at the core of the Foundation’s work today: Improve Awareness; Develop Better Treatments; Find a Cure.

As a member of the Board during the organization's early years, he took it upon himself to establish the Research Grant Program. The program's purpose was to attract leading researchers from around the globe to apply for seed money grants to further develop a hypothesis for external funding at the National Institutes of Health or other organizations in the hopes of identifying durable treatments and a cure for RLS.

As the RLS Foundation approaches its 30th anniversary in 2022, the RLS community is thankful for Bob spearheading the Research Grant Program effort at this pivotal point in the organization's early years. Member support of this initiative has led to 48 grants totaling nearly $2 million in funding. In 2022, the Research Grant Program will celebrate its 25th anniversary. Bob's leadership and vision for the program has led to breakthrough discoveries in genetics, iron regulation, neurophysiology, and treatment.

Bob received the prestigious Ekbom Award in 2008 in recognition of his meritorious service to the RLS Foundation.

Memorial donations in his honor can be made to the Waterman Memorial Research Fund to support RLS research.