Restless Legs Syndrome Foundation Blog

Clinical Insights Into Observational Studies

By Dr. William Ondo, Director of the RLS Quality Care Center at Houston Methodist Neurological Institute

Medical epidemiological studies, also called observational studies, assess information from existing data sources. These studies often make news headlines, reporting “associations” between some factor (e.g., medicine, food, activity) and some outcome (typically a feared medical condition). No epidemiology/observational study can ever deduce that one factor “caused” the other, a distinction that is often blurred by media sources. A classic example: there is an extremely high association between ice cream consumption and deaths by drowning. However, it is unlikely that ice cream consumption causes death by drowning and unlikely that death by drowning causes more ice cream consumption. It is much more likely that both occur more in summer, which explains the association. Although a useful, fast, and inexpensive mode of study has heralded many medical advances, in isolation, retrospective epidemiology studies are among the least scientific and potentially misleading forms of analysis.

One recent observational study correlated the use of gabapentin with developing dementia.¹ This study incorporated many of the statistical strategies used to improve the accuracy of observational studies. However, even the most strenuous and well-meaning analysis can’t overcome the potential for bias in any retrospective (analyzing previously collected data) study. This specific study compared 26,416 patients who used gabapentin for low back pain against 1,103,678 patients who did not take gabapentin for low back pain. All diagnoses were based on recorded standardized electrical diagnosis codes. The researchers from this study then used a complex process to make the larger non-gabapentin group more similar to the gabapentin group by specifically selecting a subset of 26,000 individuals from the non-gabapentin group to use in the direct comparison. By doing this, the researchers can “correct” for some intrinsic differences to make the comparison relatively more fair. Patients with other established risk factors for dementia that might bias the group (independent of gabapentin use) were excluded. At the end of this correction, the two groups were similar for age, sex, race, hypertension, diabetes, heart disease and some other disorders that have been associated with developing dementia, based on electronic medical record data.¹

However, researchers can’t correct for every factor. Fortunately, the authors of this study included the baseline characteristics of the 26,000 gabapentin group vs. the 1.1 million non-gabapentin group. Overall, the gabapentin group was much “sicker,” older, and had many additional factors that would otherwise increase their risk for dementia. Although the researchers corrected for some of these, they could not correct for many other potential dementia risk factors, such as hearing loss, social isolation, obesity, physical activity/exercise, and general attitudes toward health/healthy lifestyles. The published results do not allow us to determine whether the gabapentin group had more of the unmeasured dementia risk factors. However, because they had higher risks across almost every other reported baseline characteristic, it is reasonable to infer that they likely had more of these unmeasured risk factors as well. It was also indicated that the gabapentin baseline group were prescribed a greater number of opioids and other pain treatments. Based on this information, the gabapentin baseline group likely had more severe pain issues, which would at least suggest less exercise and more social isolation.

Potentially the biggest uncorrected risk factor for these types of observational studies is the frequency of health care visits. The more a person seeks medical assistance, the more likely they are to receive treatment and obtain a diagnosis for medical conditions. No individual who has not seen a physician is diagnosed with dementia and patients who visit a physician less often are also less likely to receive a subsequent diagnosis of dementia. This is a major, although underrecognized, intrinsic bias with all observational studies.

Other issues that may account for bias include the accuracy of the medical records, since no patient was interviewed or completed any type of questionnaire for this study. Further, generalizations to one disease (back pain) cannot always be attributed to another (RLS). For example, alpha-2-delta ligand medications (gabapentin, gabapentin enacarbil and pregabalin) improve sleep in RLS, which is known to lessen dementia risk in general. Specifically, they increase deep (delta) sleep, which is also hypothesized to reduce dementia.

Unfortunately, proper scientific studies to prove causality require prospective (collecting data moving forward in time) trials, which are lengthy, expensive and very challenging. With respect to this study, proving an association between gabapentin and dementia would require randomizing thousands of similar people to take either gabapentin or a placebo, with no chance of taking similar medicines. Participants are followed regularly for 10-15 years, examining how many in each group develop dementia. That idealized version of the study is essentially impossible on practical, financial and ethical grounds. There are high quality, but short (12-48 week) randomized prospective trials demonstrating the benefit of gabapentin enacarbil and pregabalin for RLS, however these can’t definitively eliminate the possibility of side effects that occur only after many years. Interestingly, there have been only a few small studies of gabapentin for RLS, but because of its low cost, long-established safety profile, and similarity to gabapentin enacarbil and pregabalin, it is commonly used.

At this point, I do not feel this association study of gabapentin with dementia should deter people from using gabapentin for RLS. We consider this medicine to be among the safest overall options for RLS.

1. Eghrari NB, Yazji IH, Yavari B, Van Acker GM, Kim CH. Risk of dementia following gabapentin prescription in chronic low back pain patients. Reg Anesth Pain Med. Published online July 10, 2025. doi:10.1136/rapm-2025-106577

RLS Foundation and American Academy of Sleep Medicine Foundation Announce 2025 Research Grant Awardees

August 4, 2025

Join the RLS Foundation Board of Directors

Shape the future of RLS advocacy and research

The RLS Foundation is seeking passionate, committed individuals to join our Board of Directors. Board members have the unique opportunity to guide the strategic direction of the Foundation, support its mission and directly contribute to improving the lives of individuals living with RLS.

Board members play an essential role in governance, advocacy, fundraising and outreach. The Foundation relies on its board to provide thoughtful leadership, expand our outreach and ensure we remain a trusted voice for the patient and medical community. We welcome applicants who bring clinical expertise, lived experience with RLS, nonprofit leadership, or who have a background in business, law, finance or communications. Many of our Board members have been diagnosed with RLS or are RLS physicians, however this is not a requirement.

Board service is both a responsibility and a privilege. In addition to participating in board meetings (virtual and in-person), members are expected to serve on at least one committee and actively support the Foundation’s programs and goals. This includes contributing time and resources and acting as an ambassador for the Foundation within your professional and personal networks.

Serving on the RLS Foundation board is a meaningful way to give back and to join a dedicated team working to advance understanding, improve care, and ultimately find a cure for RLS. If you are interested in learning more about board membership, please contact info@rls.org for more information.

2025 Hill Day FAQ

The RLS Foundation is hosting its annual Hill Day event on Monday, October 6. Hill Day is an opportunity to unite with fellow RLS community members to meet with legislative staffers and advocate for key issues. This is an all day in-person event, coordinated with the Health and Medicine Counsel of DC (HMC), an organization that guides the Foundation's advocacy efforts. We'd love to have you join us on Capitol Hill! Read through the FAQ below, or please email adrianna@rls.org with additional questions or concerns.

Agenda: Monday, October 6, 2025*

8:00 AM: Welcome Session at Health and Medicine Counsel: 50 F St NW, Suite 730, Washington, DC

8:45 AM: Walk to US Capitol Hill for group photo

9:15 AM: Walk 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.

Preparation

What are we advocating for?

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. See the legislative agenda for details.

What should I bring with me?

A valid ID is required to enter all government buildings. Bring any notes you have prepared to share with legislators. You can take a small bag with your wallet, ID, camera, portable phone charger, or other personal effects. Water and unopened snacks are permitted inside the building. Prohibited items include perfumes, pepper spray, aerosol containers, weapons, backpacks, and suitcases as you will have to go through security.

What is the dress code?

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

The Restless Legs Syndrome Foundation is a nonpartisan organization. We are fortunate to have strong working relationships with both sides of the aisle that has resulted in continued advocacy success for our community. To maintain a nonpartisan and professional environment during our hill day, please refrain from wearing clothing or accessories with political slogans or affiliations.

What is the Health and Medicine Counsel (HMC)?

The 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.

Will I receive training prior to meeting with representatives?

There are advocacy materials available on our website under the “Advocacy” Tab. On Monday morning there will be a welcome session with HMC representatives who will prepare you for the day.

How can I prepare for Hill Day?

Step 1: Register at: www.rls.org/hillday. Registering in advance allows our HMC representatives to target legislators in your state and district.

Step 2: Create your story. Meetings with representatives will be brief, so preparation is key. Representatives want to hear why the policies they pass impact their constituents.

Step 3: View our advocacy resources under the “Advocacy” Tab at www.rls.org.

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

What To Expect

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

Advocacy can seem daunting, but it will not take you long to gain confidence! 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, but you will receive your schedule the day of. You will likely meet with 5-7 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.

Who do we meet with?

You will meet with legislative staffers who are responsible for listening, asking questions and taking notes during the meeting. Legislative staffers are essential in helping legislators make informed decisions and effectively serving constituents.

How is each meeting structured?

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!

After introductions, an RLSF representative will explain what RLS is and what the RLS Foundation does. You will then share your story in 2-4 minutes. The HMC representative 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.

What is my role in this meeting?

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. Prepare your story in advance, as you will have 2-4 minutes to share.

How much walking is required?

Please note that congressional buildings are quite large and navigating them will involve a significant amount of walking. Based on past events, on average you will be walking six miles in total. We recommend wearing comfortable shoes and being prepared for an active day. If you have any walking impairments or mobility concerns, we recommend planning ahead to ensure a comfortable experience.

Travel

Where do we meet?

We will meet at the HMC Headquarters located at 50 F St NW, Suite 730 Washington, DC 20001.

I am commuting by car. Where can I park?

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

Can I commute by train?

Yes, the HMC office is just a short walk from Union Station.

What hotels are in the area?

There are many hotels in the area, both within walking distance and driving distance of HMC Headquarters.

Options within walking distance:

- Phoenix Park Hotel: 520 N Capitol St. (2 min walk)

- Hilton Washington DC Capitol Hill: 525 New Jersey Ave NW (3 min walk)

- Kimpton George Hotel: 15 E St. NW (3 min walk)

Options within driving distance:

- Hilton Garden Inn: 2020 Richmond Highway Arlington (12 min drive)

- Lyle Hotel: 1731 New Hampshire Ave NW (15 min drive)

- Cambria Hotel Capitol Riverfront: 69 Q St SW (10 min drive)

- State Plaza Hotel: 2117 E St NW (15 min drive)

- Hilton Washington DC National Mall The Wharf: 480 L'Enfant Plaza SW (10 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!

Welcoming the RLS Foundation's New Board Chair

The RLS Foundation is pleased to announce that Jeffrey Durmer, MD, PhD, has been elected chair of the Foundation’s Board of Directors. Dr. Durmer joined the Board in 2019 after serving nearly 10 years on the RLS Foundation Scientific and Medical Advisory Board. He is a systems neuroscientist, neurologist and sleep medicine physician with expertise in technology-enabled sleep-health delivery systems. He is the chief medical officer of Absolute Rest, where he oversees the development of innovative technology-enabled precision medical and behavioral programs designed to enhance human health, longevity and performance. He is also the telemedicine principal investigator for the Sleep SMART clinical trial, the largest sleep apnea and stroke study funded by the National Institutes of Health (NIH). His past research spans from uncovering the neuroanatomical and neurophysiological substrates of subcortical visual systems involved in blind sight, to developing the first standardized clinical interview tool for pediatric restless legs syndrome.

Q: Thank you for giving us the opportunity to introduce you as the Board Chair of the RLS Foundation! How did you become involved with the Foundation?

I first became involved with the RLS Foundation as a researcher at Emory University. At the time, I was directing the Emory Pediatric Center and the adult sleep laboratory, working to identify various RLS phenotypes with Emory’s Clinical Research in Neurology (CRIN) Program and collaborating with the Decode Project in Iceland.

I was working with Dr. David Rye and Dr. Don Bliwise, who introduced me to the RLS Foundation’s Research Grant Program, which has funded over $2 million in research to date. I thought it could be a great opportunity to fund research characterizing the phenotypes of children with RLS and further understand the relationship between RLS and ADHD. I submitted an application and became an RLS Foundation Research Grant recipient in 2005. During that period, I had a research poster featured at the annual American Academy of Sleep Medicine meeting, where I met Karla Dzienkowski, who is now the RLS Foundation executive director. Karla’s interest in pediatric RLS research led to multiple discussions, and she persuaded me to join the Foundation’s Scientific Medical Advisory Board (SMAB). I worked on the SMAB for eight years, helping support the Foundation’s work in pediatrics.

Q: In October 2024, you became the new Board chair. What are some of your responsibilities in this role?

The RLS Foundation is a dynamic and fluid organization, responsive to the needs of people with RLS. We are an advocacy organization, first and foremost, which includes funding pilot projects to advance research into multiple aspects of RLS, providing education and support programs for patients and families, representing the interests of patients, researchers and clinicians, and helping governmental agencies from the NIH to Congress understand the importance of addressing this very common condition and its associated medical comorbidities. As chair, my role is to create clarity and ensure our actions are reflective of our values and mission. My goals for the Foundation are to help it embrace technological and organizational innovation to grow our audiences, refine our financial efficiencies, and improve connectivity between RLS researchers, clinicians, patients and their families.

As someone with extensive experience managing businesses, clinical laboratories and healthcare operations, I look forward to guiding the Board toward a sustainable structure that supports continued growth throughout and after my term.

Q: Do you believe that your previous work on the SMAB complemented your role on the Board?

Absolutely. In addition to understanding the work of the Board of Directors, I understand the pressures the researchers and clinicians on our SMAB face – both in their practice and on behalf of the organization. I believe there needs to be a transparent and dynamic relationship between the SMAB and Board of Directors to foster collaboration and sustained proactive organizational growth in the future.

I also want to identify how the Board can assist Karla and the Foundation in their work with the SMAB. The more proactive we become, the less reactive we will need to be within the Foundation when issues arise.

Q: What led to a specific interest in RLS?

I was recruited from the University of Pennsylvania to the Department of Neurology at Emory University. My previous work focused on the consequences of sleep deprivation, the individual variability of the impact of sleep disorders on health and function, and the neuroanatomical structures involved in normal and pathological sleep.

When I got to Emory, I found that the team was more focused on movement disorders, so I made a decision to learn more about the basic science and the animal modeling associated with RLS. I found a clinical “missing link” within pediatric RLS. While there were publications and some research being conducted, there was no standardized way to diagnose and treat RLS in pediatric populations. I decided to switch my focus from cognition and the neurocognitive consequences of sleep deprivation and performance to RLS in children.

Q. What is your advice for those struggling with RLS?

Know that you are not alone. Your symptoms are shared by millions of other people. By joining the RLS Foundation, you will find a community of people going through similar experiences who can provide hope.

Membership to the Foundation not only connects you with a support network, but also keeps you informed on the latest RLS research and news. As we know, being part of a community promotes mental and physical health, and when that community is focused not only on connectivity but also creating solutions to a major health issue, it serves you, your family and the rest of humankind.

The full interview with Dr. Durmer is available in the Winter 2025 edition of NightWalkers, our quarterly magazine. You can access the complete article by logging into the member portal of the RLS Foundation website. If you are not yet a member, we invite you to become one today by visiting www.rls.org/joinnow.

Welcoming The RLS Foundation's Newest Team Member!

Elyse Hopfe is a recent graduate of the University of Texas at Austin, where she earned her degree from the Stan Richards School of Advertising & Public Relations. During her academic years, Elyse developed a strong foundation in strategic communication, public engagement and community outreach. She has extensive experience facilitating both group and individual peer support meetings, with a strong emphasis on mental health and wellness. Elyse joined the RLS Foundation as Program Manager in May, where she will oversee several key initiatives, including the Foundation’s volunteer support network, social media, webinar series and other outreach programs aimed at supporting individuals affected by RLS. Her passion for advocacy and communication will be instrumental in expanding the Foundation’s reach and strengthening its connection to the RLS community.

How were you introduced to the RLS Foundation and what sparked your interest in pursuing a position here?

I was introduced to the RLS Foundation through a job listing that one of my UT professors sent me. I applied as quickly as I could when I found out that I could make a difference for RLS patients using health communication. I know by experience the difficulty of living with a chronic condition, and I know that feeling less alone is a tether of support that I want to always provide people with. Once I met and shared stories with the kind and passionate RLSF staff, I knew that the position was meant for me.

Based on what you’ve learned about RLS at this point, why do you feel it is important to increase awareness of the disease?

I am still discovering more and more about RLS every day, but I know that increasing awareness is essential because of how much life-changing progress is yet to be made. By hearing the stories of RLS sufferers and watching doctors recount their extensive research and experience in treating RLS patients, I learned the absolute necessity of making things better for those with RLS, which starts with making the rest of the world listen. The RLS Foundation has such an impactful history surrounding its growing community, and increasing awareness about the disease will lead to more discoveries and discussions for everyone who becomes involved.

What influenced your passion for mental health and wellness advocacy? What practices or philosophies do you want to integrate into the support meetings hosted by the Foundation?

My passion for mental health and wellness advocacy derives originally from my own battle with mental health, but it has since evolved after my collective volunteer experience leading both group and individual support. Having a therapist can be amazing, but there is a differently beautiful and powerful connection to be gained from supporting and receiving support from fellow community members who have shared your experiences in a non-clinical environment. Talking circles are an ancient practice from Indigenous cultures, including those in Canada and in the US, and I want the restorative effects of support groups to be recognized as a gift from that learned practice. As the manager of the volunteer support program at the Foundation, I want all of our support spaces to be nonhierarchical, to feel safe for leaders and attendees, and to be inclusive for anyone seeking support for their lived experiences with RLS.

What aspects of the RLS Foundation’s mission resonate most with you?

I really resonate with the action-oriented idea behind our mission. The Foundation is not passively existing to host the connections within the RLS community, but it is alive and working to make change for people who have the disease through advocacy, research, and overall education and awareness. I want to be the change, not just someone witnessing it.

What are you most excited about in your new role as program manager?

I am most excited to get to know you: whoever is reading this. I am very willing to learn more personal stories about what living with RLS can be like and I want to be extra informed when I get to contribute to exciting things like our monthly webinars, social media, and chats with support group leaders, too.

What would you like volunteers and community members to know about you as you get started?

I want everyone to know that while I do not experience RLS myself, I am devoted to amplifying the voices of the people that do. I will surely make mistakes as I acclimate to my role at the Foundation but rest assured, I am open to reframing how I navigate the complexities involved with providing the best experience for all volunteers and community members at RLSF. Please reach out to me at elyse@rls.org if you want specific resources or if you feel inclined to get to know me a bit better. I am very grateful to be part of this very personal mission.

Outside of work, how do you like to spend your time?

I absolutely love the Texas heat, and I very often swim or walk outdoors. I am an avid reader, thrifter, and video editor when I’m not spending time with my friends. My nightly routine often includes cooking something nostalgic with my television playing in the living room. Recently, I’ve been teaching myself how to play bass guitar, but I’ve never played for an audience!

Do you have a favorite quote or motto that inspires your work?

A motto that I have internalized from yoga class is “kind mind, kind body, kind spirit.” Whenever I feel lost, or purposeless, or not good enough, I remind myself that acting through kindness will result in work that is honest and true.

Advocacy Action Alert: Sign-On Letter for the Sleep Community

Advocacy is an important part of the RLS Foundation's work to increase awareness and promote RLS research. We ask RLS community members to participate in Advocacy Action Alerts to expand our reach within Congress. If you have any questions, please email adrianna@rls.org.

Background: Congresswoman Zoe Lofgren (D-CA) is leading the annual appropriations sign-on letter for Fiscal Year (FY) 2026, calling for enhanced support for sleep health and medical research activities. The letter encourages further coordination and new initiatives across the Department of Health and Human Services so that ongoing breakthroughs in medical research are connected with earlier diagnosis, better patient care, and enhanced professional education and public awareness.

Why It’s Important: This letter is open for congressional House members. Increased support from House representatives improves the likelihood that sleep-related recommendations will be incorporated into the final appropriations legislation. Your member of Congress will only sign on to the letter if they are asked to do so by you, their constituent.

Request: Please contact the office of your House Representative and ask that they continue to support the sleep, circadian, and sleep disorders medical research and public health priorities by joining the community’s annual appropriations letter.

Steps to Take Action:

*Complete Step 1 as soon as possible, as you will need the contact information before completing the rest

1. Contact our Washington representative, Matt Duquette at duquette@hmcw.org. Matt will provide the contact information of the Health Legislative Assistant in your Representative’s DC office. Provide your home address and zip code so Matt can identify your House Representative’s Health LA.

Email Subject Line: Congressional Sign-On Letter - RLSF

*Please cc: Adrianna Colucci, RLS Foundation Communications Coordinator (adrianna@rls.org)

3. Email the Health Legislative Assistant, when you receive their contact information, using the sample message below. Please copy and paste the message below into an email, as the representatives will need the link to sign-on. Attach the sign-on letter that you downloaded to the email.

**Sample Message**

Dear [Staffer Name],

I am reaching out today as an advocate for the sleep disorders community and as a constituent from [your hometown]. On behalf of local advocates impacted by restless legs syndrome, I hope your office will join the annual appropriations letter in support of timely report language focused on sleep research and public health activities. The FY 2026 letter is attached and you can complete this form via Quill or contact Arlet Abrahamian at Arlet.Abrahamian@mail.house.gov. Thank you for your time and for your consideration of this request. Please sign on by Friday, May 16th.

[Briefly share your personal RLS story in 2-3 sentences.]

Thank you for your time and your consideration of this request. I look forward to hearing from you in this regard.

Sincerely,

[Name]

[Address]

****

*Please Note: The “quill” link in the sample message will only work for congressional offices (individuals and organizations cannot use it to sign the letter). If you copy and paste the message into an email, the link should be included. The link is also embedded in the sign-on letter.

It is important to reach out as soon as possible, to ensure that your congressional offices have time to review and approve the letter. Thank you for your support as an advocate! If you have questions, please email adrianna@rls.org.