NEWS & EVENTS
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Sleep Disorders Research Advisory Board (SDRAB) Meeting – August 1, 2024

Fully Virtual.

Description

The Sleep Disorders Research Advisory Board (SDRAB) convened virtually on Thursday, August 1, 2024, from 1:00 PM ET to 4:00 PM ET. SDRAB is a Federal Advisory Committee established by the NIH Revitalization Act of 1993 and the purpose of this meeting was to update the Advisory Board and public stakeholders on the progress of sleep and circadian research activities across NIH, and the activities of Federal stakeholders and interested organizations. Dr. Esra Tasali presided over the meeting as Chair and the minutes appear below.

Meeting Summary

BOARD MEMBERS PRESENT
Dr. Esra Tasali, Chair
Dr. Josiane Broussard
Dr. Paula Desplats
Dr. Jeffery Durmer
Dr. Erik Herzog
Dr. Dayna Johnson
Dr. Shaun Purcell
Dr. Alberto Ramos
Ms. Alexandra Wharton

BOARD MEMBERS ABSENT
None

EX OFFICIO MEMBERS PRESENT
Dr. Marishka Brown, Executive Secretary
Dr. Yejun (Janet) He
Dr. Amanda Hunt

FEDERAL EMPLOYEES
Twenty-two Federal employees attended the meeting.

MEMBERS OF THE PUBLIC
Forty-nine members of the public attended the meeting (including researchers, clinicians, patients, and other stakeholders).

CALL TO ORDER
Marishka Brown, Ph.D., SDRAB Executive Secretary

  • The executive secretary called the meeting to order at 1:00 PM ET as announced in the Federal Notice [89 FR 51892] on June 20, 2024. The meeting was fully open to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act.
  • Board members were reminded they are required to absent themselves if their presence constitutes or appears to constitute conflict of interest.
  • Dr. Brown introduced the chair of SDRAB, Dr. Esra Tasali.
  • The Chair welcomed everyone and SDRAB members introduced themselves.

DIRECTOR’S REPORT - National Center On Sleep Disorders Research (NCSDR)
Marishka Brown, Ph.D., Director, NCSDR

  • Dr. Brown began her presentation by reminding the audience of the purpose of SDRAB:
    • NIH uses 4 different types of Advisory Committees; the SDRAB is a Program Advisory Committee (PAC) and its function is to provide advice to the NCSDR director and the NIH director on specific research programs, and future research needs and opportunities.
    • The SDRAB Charter states “The Board makes recommendations on research priorities conducted or supported by the Institute...”
  • She also introduced and welcomed the new ex officio Board members, some of whom were present:
    • Amanda Hunt, Ph.D., who is a scientific program manager representing the Veterans Administration (VA)
    • Shelli Avenevoli, Ph.D., Acting Director of the National Institute of Mental Health, who replaced Dr. Joshua Gordon.
    • There are also several nominations for new Board members that are pending.
    • Current information about SDRAB members as well as future/past meeting dates and minutes can be found on the SDRAB website.
      Dr. Brown then summarized sleep and circadian funding across the NIH and discussed implementation of Strategic Goal 2 of the NIH Sleep Research Plan. That goal is to improve the treatment of sleep and circadian disorders, which includes personalized approaches and moving towards treatment and health for all. Her presentation primarily focused on the INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down SyndromE) and sleep and circadian research opportunities within that program.
  • NIH-wide research initiative that began as a supplement program in 2018 but has since grown into a full blown, well supported research program. NIH has invested $345 million over 6 years in 330 new projects
  • Investigators interested in Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) are also starting to submit applications to INCLUDE because people with Down Syndrome (DS) are at higher risk for developing AD and they do so at a younger age
  • A brief Board discussion about research opportunities in the INCLUDE program followed:
    • Although current DS trials focus on pediatric populations, adults are also looking for options beyond adenotonsillectomy and CPAP which have not always been effective
    • Persons with DS are now living into adulthood, but there are significant health disparities.
    • The sleep problems in this population affect not only the person with DS but also their caregivers
    • The combination of sleep issues and dementia in the same population creates a rich opportunity to study the relationship and interplay between these two conditions
    • There is a potential for the sleep research community to significantly add to the quality of life for this population
  • Funding Opportunities in sleep and circadian research were shared:
    • The National Institute on Drug Abuse (NIDA) has two opportunities looking at mechanistic studies to investigate the interrelationship between sleep and a circadian rhythms and substance use disorders RFA-DA-25-044 and RFA-DA-25-045
    • The National Institute of Mental Health (NIMH) has a request for applications on optimizing behavioral sleep interventions for adolescents and young adults RFA-MH-25-130
    • The National Heart, Lung, and Blood Institute (NHLBI) has a notice of special interest that is focused on diagnostics in underserved populations and includes circadian based strategies NOT-HL-22-024
    • The National Institute on Minority Health and Health Disparities (NIMHD) has an initiative on interventions to reduce sleep health disparities that is being co-sponsored by multiple NIH institutes and centers, including NHLBI, PAR-24-110
    • She reminded the audience that all investigator-initiated mechanisms are open to sleep and circadian biology research.
  • NCSDR staff will be attending the following upcoming professional conferences

LEADERSHIP LENS: All of Us Updates
Joshua Denny, M.D., M.S., CEO, All of Us (AoU)

  • Dr. Denny gave an overview of All of Us (AoU), which was established by the 21st Century Cures Act in 2016 and launched nationally in 2018.
  • The program is designed to accelerate health research and medical breakthroughs enabling individualized prevention, treatment, and care for all of us
  • Goal is threefold:
    • Nurture longitudinal partnerships for decades with at least one million participants who reflect the diversity of the U.S.
    • Deliver one of the largest, richest biomedical datasets that is broadly available and secure
    • Catalyze an ecosystem of communities, researchers, and funders, who make AoU an indispensable part of health research
  • To date, 825K+ participants have been enrolled
    • 582K+ have donated DNA; at least 80% of those also have other biospecimens
    • 452K+ electronic health records (EHRs)
    • Representation from all 50 states and most U.S. territories
    • Extremely diverse in terms of race/ethnicity, age, income, sex/gender identity, sexual orientation, disability, healthcare access, urbanicity/rurality
    • Over 87% of AoU participants are underrepresented in biomedical research
  • The AoU Research Hub is a public data browser that provides access to summary statistics of:
    • EHR data (conditions, drug exposures, labs, measurements, procedures)
    • Genomic variants
    • Survey questions (including COVID-19 surveys)
    • Physical measurements
  • The Researcher Workbench provides registered researchers tiered access to row-level data for analysis
    • Cloud-based platform providing access the following types of data:
      • Participant surveys - 413.3K+ (survey questions focused on information not represented in EHRs such as social determinants of health)
      • EHRs - 287K+
      • Physical measurements - 337.5K+ (blood pressure, BMI, heart rate, weight, height, hip circumference, waist circumference)
      • Biospecimens - 245.3K+ whole genome sequences; 1K+ long-read sequences (blood, saliva, urine, DNA, RNA, cell free DNA)
      • Mobile/wearable tech - 15.6K+ Fitbit records (heart rate, daily activity, activity intraday, sleep data)
      • Assays - 1.5M+ structural variants (COVID serology)
      • Omics - 312.9K+ genotyping arrays
    • Open to national and international researchers at academic, not-for-profit, and health care institutions
    • No separate IRB approval needed
    • Researchers can typically set up an account, gain access to the data, and begin working in 4-29 hours if their institution already has a master Data Use and Registration Agreement (DURA). Check here to see if your institution is registered
  • Nearly 600 papers have been published using AoU data
  • A broad range of sleep disorders captured in the EHRs using a combination of diagnostic codes, procedures, medications, and labs. In addition, there is data derived from Fitbit devices, which span a wide range of possibilities, including:
    • Investigate trends of device generated data (e.g. activity, sleep, heart rate over time)
    • Examine sociodemographic diversity
    • Correlate with EHR and genomics data
    • Correlate with other datatypes (e.g. surveys)
    • Conduct cross-sectional and longitudinal studies
    • Build predictive models
  • The AoU website contains a Research Project Directory that can be searched for active projects in sleep and circadian research. Sample study topics include:
    • Mental health and sleep
    • Sleep disorders and prenatal outcomes
    • Correlations between OSA and AD
    • Genetics of sleep disorders and relationships with comorbid disease
    • Substance abuse and sleep
  • Sleep publications using AoU data can be found here and to date include:
  • Dr. Denny concluded his remarks by mentioning these ancillary studies which will have a positive impact on increasing access to a research-ready, diverse national cohort.
  • Board Discussion:
    • AoU received Fitbit API data which is not “raw” sleep data in the strictest sense because it comes in a structured format. But the sleep data do include timestamped details of sleep stages and episodes.
    • Many of the most commonly used drugs act on targets that follow circadian rhythms. If the individualized data that is returned to participants could include information on the best time of day to take the medications, that could have a profound impact on the efficacy of their medications and potentially their health. This could increase public awareness about chronomedicine and ultimately physician awareness about how to prescribe medications and therapies.
    • It could be beneficial to the community to potentially integrate the AoU Fitbit data with the National Sleep Research Resource (NSRR). The possibilities will be explored by NIH staff.
    • It was recommended that an AoU sleep working group be formed to advise on the consistent and appropriate analysis of the sleep measures, to assist with data harmonizations and publish papers on best practices.

SCIENTIFIC FOCUS PRESENTATION – Using 24-Hour Behaviors & Triad as Combined Interventions for Weight Loss
Marquis Hawkins, Ph.D., Assistant Professor of Epidemiology, University of Pittsburg

  • Dr. Hawkins research is to understand the joint impact of sleeping and waking behaviors on maternal health using epidemiological and clinical research methods.
  • Presented current research that focuses on developing an intervention tailored to postpartum individuals that integrates sleeping and waking behaviors together.
  • Maternal adiposity during and after pregnancy occurs at a critical time for interventions to shape inter-generational cycles of disease morbidity because it is associated with:
    • Pregnancy complications such as hypertensive disorders of pregnancy, miscarriage, and still birth
    • Birth outcomes such as congenital abnormalities and large for gestational age infants
    • Longer term outcomes such as childhood adiposity, postpartum weight retention and the development of cardiovascular disease
  • The impact of sleep has been underrepresented in research, particularly in studies of the postpartum period where it is just assumed and accepted that sleep will be poor. However, sleep is a modifiable behavior that can be targeted and that may provide a good opportunity to amplify the effects of some traditional weight management interventions, particularly among those disproportionately burdened by sleep disruptions.
  • Dr. Hawkins expressed ways circadian-based strategies (e.g., sleep, timing of medication, timing of meals) might improve the efficacy of treatments for heart, lung, blood, and sleep disorders.
  • He described the conceptual framework for his study “Sleep GOALS” (Goal-focused Online Access to Lifestyle Support), in which the 3 behaviors – diet, physical activity, and sleep – are linked together through the circadian timing system
  • Semi-structured interviews with postpartum individuals were conducted to understand their perspectives on sleep, diet, and physical activity and to get participants’ perspectives on what modules from each intervention should be integrated into a single 16-week intervention.
  • A comprehensive plan for implementing the program was developed and recruitment is currently underway.
  • Dr. Hawkins ended his presentation with the following summary:
    • Sleep, diet, and physical activity are interrelated behaviors
    • Many postpartum individuals expressed a need for an intervention addressing each
    • Sleep GOALS was iteratively designed, with participant feedback, to address this need
  • A brief Q&A session with the Board followed his presentation

STAKEHOLDER GROUP UPDATE – National Academies of Science, Engineering, and Medicine (NASEM)
Clare Stroud, Ph.D., Senior Board Director, Board on Health Sciences Policy, NASEM

  • Dr. Stroud gave an overview of the National Academies.
  • NASEM serves as an independent, evidence-based body that can provide advice to Congress, federal agencies, and other entities.
  • There is also a large programmatic arm of NASEM which:
    • Develops Consensus Studies - by synthesizing what is known from the science and other evidence, and making recommendations
    • Serves as a neutral convener for people from across different sectors around particular topics
  • In 2006, NASEM developed a consensus study entitled Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem
  • Dr. Stroud shared NASEM is now proposing to develop a new consensus study on sleep. One of NASEM’s convening activities is called the Forum on Neuroscience and Nervous System Disorders and in November 2022, that forum hosted a workshop entitled Exploring Sleep Disturbance in Central Nervous System Disorders.
  • That workshop underscored how much the science in the field had advanced since 2006 yet, there continues to be a major gap between compelling evidence on the importance of sleep and action to address this critical public health need. This realization led NASEM to propose a new consensus study, Sleep Across a Lifespan: Implications for Health and Research. The goal would be to serve as an agenda-setting report that:
    • Takes stock of major recent advances in sleep and circadian science
    • Synthesizes current evidence on the relationships between disordered/disturbed sleep and increased risk of disease, and pulls together threads from across disease areas
    • Integrates knowledge regarding environmental influences and health equity considerations
    • Builds on and complements the NIH Sleep Research Plan
    • Examines opportunities to improve sleep monitoring in clinical and occupational settings and to integrate consideration of sleep into clinical trials across therapeutic areas
    • Highlights key opportunities for action by government, academia, industry, and the non-profit sector to bridge the gap between sleep research and implementation of measures to address this public health need
    • Leverages NASEM’s influence with biomedical researchers and the public health and health care workforce to expand awareness and inspire action
    • NASEM is currently working on refining the scope of the project, making sure they are capturing all the key issues, and identifying a coalition of sponsors to fund the effort. Feedback from SDRAB was requested on the draft and for input on the biggest opportunities for where the research is strong but not being translated into action.
  • Board discussion followed the presentation.
    • The Board noted that looking at the positive impact of sleep on performance and longevity is an area of intense interest within the public and even in some clinical settings. The suggested framing could be around sleep health.
    • NASEM is working on ways to involve patients with sleep disorders at different points in the process to make sure their perspective is represented as well.
    • Dr. Stroud confirmed the evidence-based synthesis of the consensus study would serve to inform recommendations for action by different actors such as government, industry, and professional societies.
    • The Board recommended it would be important that each mention of “sleep” in the report also include a mention of “circadian” and that NASEM work with the Society for Research of Biological Rhythms on this effort.
    • The SDRAB provide Dr. Stroud recommendations of researchers that could provide meaningful guidance to this effort.

PUBLIC QUESTIONS/COMMENTS

  • There were no additional questions or comments from the public that had not already been addressed in earlier discussions.

SDRAB MEMBER DISCUSSION
Lead by Dr. Esra Tasali

  • The SDRAB had an extended discussion and points included:
    • The Board noted that reallocation modeling or compositional modeling where you consider the 24 hour period and how it is being spent within specific activities is being utilized more in research.
    • The Board commented that while timing of activities is important, it is also important to keep personalization of interventions at the forefront when considering implementing sleep health recommendations.
    • In terms of tracking the impact of NASEM consensus studies, in addition to counting the number of downloads of a report or the engagement with the different materials that are developed based on the report, policies that cite a NASEM report are also tracked.
    • SDRAB recommended that a sleep/circadian working group be formed for AoU to bring domain specific expertise and tools into that resources and to inform and leverage their data curation and harmonization.

The meeting adjourned at 4:00 PM.