Considerations for Professionals

Guide for Researchers Involving Participants Who Have Hypersomnias

Vetted by Our Medical Advisory Board

This guide’s* purpose is to help researchers effectively recruit and retain participants for their studies, improve study design and validity of results, etc. A concomitant goal is to help reduce the burdens experienced by person(s) with hypersomnias (PWH) when they choose to participate in research studies, by ensuring staff and researchers appreciate the full range of PWH hardships, including financial stressors, that may be encountered during these studies and by providing suggestions to address them.

Develop an Understanding of the Experiences of PWH

It is important for researchers working with PWH to be informed about the various hypersomnias and the evolving research in this arena (see IH Summary, About IH, About Related Sleep Disorders, and Classification of Hypersomnias). For example, differentiation among physical fatigue, mental fatigue, and sleepiness can improve diagnostic accuracy, understanding of the symptomatic burden, etc.

Many PWH have lost a good part of their lives to sleep and brain fog/cognitive impairment. Volunteering for a research study, which many of them have done, is a way of serving a humanitarian need. They sacrifice their family time, their income and more to provide this service.

  • PWH often have very limited mental energy and wakeful time. The Spoon Theory1 may help in understanding this limitation.
  • When participating in a study, PWH are not allocating their limited energy/time to their usual priorities, e.g., household tasks (cooking, cleaning, projects), taking care of their children/grandchildren, working part or even full-time, or going to appointments; instead, they must allocate their limited time/energy to the study.
  • Motivation is key. Participating in a research study needs to be worth giving up their limited time/energy.

Recognize That Research Studies Can Become an Ordeal for PWH and Participation Can Worsen Their Daily Hardship, Especially When:

  1. They are expected to stop taking the medications that have provided some sense of stability and functioning in their lives; 
  2. Treatments used during the research study, which may have been helpful, are stopped; 
  3. There are significant financial costs for participating, especially if travel to the research location is required or loss of work hours results in reduced income.
  4. Enrollment in the study requires medical expenses/efforts, such as records requests and/or medical forms (with associated fees); specific birth control when the drug being tested may not yet have been evaluated for reproductive toxicity; time-consuming appointments, etc.; 
  5. Maintenance of Wakefulness Tests (MWT) and Multiple Sleep Latency Tests (MSLT) are required, as these can be extremely unpleasant for PWH;
  6. Staff unfamiliar with the unique needs of PWH may have expectations that come across as unreasonable given the often misunderstood, invisible, or unknown symptoms of the PWH.

Be Aware of Ways to Help Offset Distress:

  • Continuously affirm the value of the participants during (and after) their participation. PWH often live incredibly challenging lives. When they participate in studies, their sacrifices include not only time, energy, and possibly their income if they are fortunate enough to have jobs or careers; they often have to stop taking their medications to participate, which can leave them very vulnerable in their responsibilities, their own safety, their emotional well-being, etc. It is very important that PWH feel that they are treated with dignity and respect while participating in studies. When researchers demonstrate that they are informed about the participants’ symptoms and aware of the impact of those symptoms on the participants’ lives, their respect for the participants is genuinely appreciated. When researchers demonstrate appreciative regard for participant involvement, they uphold and affirm the value of the participants’ contributions.
  • Be sensitive to diversity, equity & inclusion (DEI), including the history of abuse of racial and other forms of power in past research studies/clinical trials. Aim to improve research participation in underrepresented communities by making diversity an internal mandate. Diverse patient voices are needed early in the development phase of trials, keeping in mind that there may be more hypersomnia underdiagnosis in underrepresented populations. Gain a better understanding of patient barriers to participating in research. Acknowledge the history of atrocities. Build trust. Widen eligibility criteria for studies. Use community health centers, not just large academic research centers. Actively promote health equity. (See the National Organization for Rare Disorders’ webinar: “Advancing Health Equity”.)
  • Determine/develop/measure patient-centered outcomes. Engage in advance with PWH and patient advocacy groups to become informed about PWH, how they live with their hypersomnias, and the outcomes that matter most to them. This can contribute importantly to successful clinical trial design and recruitment. For example, when designing research studies, take into account whether improved cognitive function/reduced brain fog may be more important for improving participants’ quality of life than only increased “wakefulness,” which can be considered “fake-awake” if not accompanied by reduced brain fog.
  • When possible, design studies that allow PWH to continue taking beneficial medications. Often in sleep research trials, PWH are required to stop current medicines that are improving their quality of life; this is in contrast to clinical trials for disorders such as hypertension, in which patients do not experience a subjective benefit from the treatments that are started and stopped.
  • Offer study treatments for compassionate use outside of the study, whenever possible (e.g., plan for open label studies after randomized studies). It can be extremely difficult for a person who participates in a clinical trial to experience an effective treatment only briefly and then have to wait a very long time (potentially years) before being able to access it again. Partnering with a company like WEP Clinical may be helpful. Once new treatments are approved, consider offering robust patient assistance programs, with a goal toward equitable access for all patients regardless of their insurance coverage and financial situation.
  • Reimburse for any required medical expenses and provide an appropriate per diem allowance. This can be very helpful to offset the losses incurred by PWH while participating in a research study. Many PWH live on a limited income, and providing the medical product (or giving the option of reimbursement) and a per diem allowance can help in a number of ways, e.g., covering the costs of childcare, services for household chores, and offsetting lost wages because PWH are not available to perform their usual duties/tasks.
  • Reduce participant burdens in any way possible, which can also help improve equity. For example, if blood draws are needed, consider whether providing them in participant homes may reduce the number of clinic visits required of a participant for a study. Regularly collect feedback on participant burdens, and consider amending clinical trial protocols during the trial based on that feedback.
  • Support the supporters who make the difference. When PWH need to travel for a research study, it can be very beneficial for them to have a supporter with them. Both PWH with long sleep durations and those with normal sleep durations may struggle with travel because of brain fog, difficulty staying awake, difficulty waking and sleep inertia. PWH and, in turn, the study can greatly benefit from a supporter’s involvement. Importantly, providing a travel allowance for the supporter as well as the patient could make the difference between a PWH participating and not participating in a research study.
  • Inform sleep study centers and research study sites of the unique needs of PWH. See our Companion Guide.
  • Utilize telehealth when clinically feasible and preferred by PWH. Note that PWH may have additional struggles with technology due to their cognitive and sleep symptoms.
  • Utilize home sleep studies, home EEG monitoring systems, and/or sleep actigraphy with sleep diaries instead of on-site sleep studies, when clinically feasible and scientifically justified. Not all PWH can be easily accommodated at sleep study centers given the nature of the symptoms and related complications. Since MSLTs/MWTs can be extremely unpleasant for PWH, consider whether they might be replaced by alternate tests.
  • Utilize AASM-accredited sleep study centers (or their international equivalent) or established academic sleep research labs, whenever possible.
  • Communicate FDA and other relevant timelines to the patient community, whenever possible. This can help patients plan for possible future access to the medication.
  • Communicate Study Results whenever possible. It can be very validating to PWH and patient advocacy groups to be informed of the results of studies in which PWH participated and provided layperson research summaries. In doing so, PWH-friendly communication formats are preferred: succinct wording, banners, bullets, checklists, more line spacing, and bold font or highlights/shading for the most salient information. Visually and verbally simplifying communications can improve understanding for PWH, despite brain fog and other cognitive difficulties. It also is validating to be informed that these results are being communicated to the scientific community. When presenting research posters, consider specific, easy-to-read formatting, with a goal to efficiently and effectively communicate the results.2

* This guide was developed by the Hypersomnia Foundation and approved by its Medical Advisory Board, Board of Directors, and Patient Advisory and Advocacy Council (PAAC). It is based on suggestions from a focus group of patient-experts who have IH and NT2; the focus group was conducted in accordance with standard qualitative methods of research practice. For the purposes of this guide, PWH refers exclusively to those diagnosed with IH or NT2. It is important to note that the considerations presented do not necessarily apply equally to all people who have IH and NT2, and that they may also apply to people who have other hypersomnias, e.g., narcolepsy type 1 (NT1) and Kleine-Levin syndrome (KLS), as well as those yet-to-be-diagnosed with a hypersomnia

  1. The Spoon Theory, by Christine Miserandino
  2. NEJM Journal Watch: The Problem with Research Posters—and a Bold Approach to Fixing Them

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