Sleep Disorders Research Advisory Board (SDRAB) Meeting – April 6-7, 2023

The Sleep Disorders Research Advisory Board (SDRAB) convened in a hybrid (in-person/virtual) meeting on Thursday, April 6, 2023, and Friday April 7, 2023. SDRAB is a Federal Advisory Committee established by the NIH Revitalization Act of 1993. The meeting opened at 1PM ET and closed at 5PM ET on April 6th and opened at 9AM ET and closed at 2PM ET on April 7th. Dr. Gabriel Haddad presided over both sessions as Chair.

Meeting Summary

DAY 1

BOARD MEMBERS PRESENT
Dr. Gabriel Haddad, Chair
Dr. Josiane Broussard
Dr. Si Baker-Goodin
Dr. Jeffery Durmer
Dr. Erik Herzog
Ms. Ebony Lay
Dr. Shaun Purcell
Dr. Alberto Ramos
Dr. Tom Scammell
Dr. Esra Tasali
Ms. Alexandra Wharton

BOARD MEMBERS ABSENT
None

EX OFFICIO MEMBERS PRESENT
Dr. Marishka Brown, NHLBI, Executive Secretary
Dr. Shahla Jilani
Dr. Karen C. Lee
Dr. Miroslaw Mackiewicz
Dr. Donald Shell

FEDERAL EMPLOYEES
Nine Federal employees attended the meeting in person and 16 were in attendance via Zoom.

MEMBERS OF THE PUBLIC
One member of the public attended the meeting in person and 59 were in attendance via Zoom (including researchers, clinicians, patients, and other stakeholders).

CALL TO ORDER

Marishka Brown, Ph.D.

• The executive secretary called the meeting to order at 1:00 PM ET as announced in the Federal Notice [FR Doc. 2023-05400] published on March 16, 2023; Amended Notice [FR Doc. 2023-06085], March 27, 2023. 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. Esra Tasali was announced as the next chair of SDRAB via election of the current board members.
• The Chair welcomed everyone and SDRAB members introduced themselves.

OPENING REMARKS

Dina Paltoo, Ph.D., MPH, Assistant Director, Scientific Strategy and Innovation, NHLBI

• Dr. Paltoo shared NHLBI’s evergreen strategic vision for accelerating sleep and circadian research, promoted this year’s 75th anniversary of NHLBI, and highlighted the NIH Sleep Research Plan across the lifespan.
• She noted the opportunity to address health disparities by identifying and understanding the role of sleep as a modifiable source of inequity. Several cohorts integrate sleep research and enable leveraging science platforms to advance scientific discovery for public health impact (e.g. All of Us, and others).
• Dr. Paltoo identified several important sleep data repositories including the National Sleep Research Resource (NSRR), Trans-Omics for Precision Medicine (TOPMed), and BioData Catalyst (BDC), that support inclusive approaches to health disparities and democratize data for all.
• NHLBI supports several significant and impactful data resources to reimagine sleep and circadian research by catalyzing discovery for public health impact and new opportunities for novel interventions and therapeutics.
• SDRAB discussed with Dr. Paltoo the collection of objective sleep measures, promoting expert usage of data across programs, and encouraging the development of new tools to mine and use available data.   

DIRECTOR’S REPORT, NATIONAL CENTER ON SLEEP DISORDERS RESEARCH

Marishka Brown, Ph.D.

• The NCSDR director described the goals and purpose of SDRAB, thanked outgoing members for their exceptional service, welcomed new members, and introduced the new NCSDR scientific program analyst.
• An update on current and future activities was provided with a focus on critical and timely opportunities such as the Chrononutrition workshop.
• The allowances and rules for clinical trials submissions to various notices of funding opportunities (NOFOs) were recapped and researchers were encouraged to contact program officials to discuss which NOFO best fits their particular research design and aims.
• Dr. Brown highlighted NIH Sleep Research Plan goal #5 - Sleep and Circadian Biology Research Workforce Development. In a review of data on individual fellowship and career development awards across NIH from 2015 to 2022 she:
  • summarized the various NIH funding mechanisms by career stage
  • focused on institutional training grants, noting there are currently 10 sleep and circadian T32s all supported by NHLBI and pointing out the less utilized T35 mechanism as an option for research training earlier in the pipeline
  • noted relatively flat nature of fellowship and career development awards in sleep and circadian biology
  • stressed the goal and importance of supporting a diverse and inclusive workforce and
  • tasked SDRAB to think rigorously and creatively about ways to expand the sleep and circadian researcher pathway
• Lastly, the NCSDR director shared the directors of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Eye Institute (NEI) will be presenting at upcoming SDRAB meetings to describe sleep and circadian research at their Institutes.
• SDRAB discussed data presented on the fellowship and career development awards, noting:
  • it appears not enough people are applying, as the success rate in sleep and circadian are comparable to other fields NIH-wide
  • there may be a need to capture potential researchers earlier in their career progression (e.g. directly after undergraduate stage)
  • discussed the teaching of sleep and circadian science in medical schools, but noted the barriers.
  • discussed the potential option of adding sleep and circadian slots to existing T32s in other areas at institutions, or multi-site T32s with multiple institutions comprising a sleep and circadian T32 program
  • examples of partnerships with societies (basic and clinical) to conduct training programs for post-bac and other relevant young scientist learners were given and ideas for additional actions were offered
  • SDRAB noted a much larger and continuous discussion about this topic is needed

NEW NIH DATA MANAGEMENT AND SHARING (DMS) POLICY

Julia Slutsman, Ph.D.—Director, NIH Genomic Data Sharing Policy Implementation
Taunton Paine, MA—Director, Scientific Data Sharing Policy Division

• NIH requires data to be shared to advance rigorous and reproducible research and to promote public trust in research.
• The current NIH DMS policy became effective on January 25, 2023 and requires the submission of a DMS plan for all competing NIH research applications and compliance with the approved plan.
• The presenters described details of the policy’s applicability and requirements, including the scope, timelines, and potential limitations to the policy for justifiable ethical, legal, and technical factors.
• In addition to the policy, several additional resources have been released:
  • plan submission and review guide for extramural grant awards
  • sample DMS plans
  • guidelines to encourage use of established repositories
  • recommendations for identifying the appropriate data repository
  • information about protecting privacy when sharing human research participant data
  • suggestions for consent in relation to the policy
  • rules about allowable costs
  • a scientific data sharing website and a data management and sharing FAQs
• Lastly, the presenters shared the White House Office of Science and Technology Policy published the 2022 public access memo that directs federal agencies supporting research to develop plans across a few key areas. NIH published its Public Access Plan for comment in February 2023.

LEADERSHIP LENS

George Mensah, M.D.
Director, Center for Translation Research & Implementation Science (CTRIS/NHLBI)

• Dr. Mensah began by providing a brief history of CTRIS and its mission, sharing the center was formed 9 years ago to serve as a strategic focal point at NHLBI for translating all discoveries towards real world impact. Specific examples of health challenges that require implementation science and research were described.
• The CTRIS organization and executive team were introduced and described. CTRIS relies heavily on collaborations with both internal and external partners.
• The importance of working with communities was highlighted as extremely important for building and maintaining trust to rapidly translate the science into practice. Examples include the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Alliance and the NIH Community Engagement Alliance (CEAL) against COVID-19 disparities.
• The director expressed his eagerness to discover ways in which CTRIS and SDRAB via NCSDR could work together to explore the convergence of sleep disorders research and implementation science. Interest in a partnership between CTRIS and NCSDR began with a workshop on the integration of implementation science in cardiovascular behavioral medicine in which multiple areas of sleep disorders and sleep health were highlighted in workshop report.
• As the research has advanced, the time is right for intensive translational activities and implementation research in sleep/circadian and health disparities research:
  • a culturally-tailored interlaced delivered cognitive behavioral therapy for insomnia (CBT-I) in black women has been proven to be effective
  • solid effectiveness of digital CBT-I compared with sleep educational alone for insomnia severity
  • improved sleep quality in older adults with insomnia reducing biomarkers of cardiovascular disease risk
  • relevant research in pregnant women
• The roadmap and process to set the stage for convergence of sleep disorders research and implementation science at NHLBI, including the significant need for evidence synthesis, were highlighted.
• In the discussion that followed, the SDRAB noted:
  • the need for tactics to address sleep factors like duration, timing, and disruption of sleep properly in various populations
  • additional areas of focus include careful assessment of existing studies that can be used to inform recommendations for implementation
  • challenges with appropriate stakeholders working together effectively to address end-user adherence needs in obstructive sleep apnea (OSA) and CPAP therapy; challenges with translating and scaling up
  • the importance of using relevant physiological metrics of sleep health broadly and systematically when moving forward in the area of OSA adherence research
  • the need for multi-disciplinary and thoughtful practice of behavior change for CPAP adherence
  • increasing awareness of the impact of sleep deficiency and sleep disorders within other disciplines to address treatment challenges.

FEDERAL STAKEHOLDER UPDATE

Rachel Fisher, Ph.D.
Public Health Advisor, HHS/OASH Office of Disease Prevention and Health Promotion
Acting Executive Director of the President’s Council for Sports, Fitness, and Nutrition

• Dr. Fisher described the history, mission, and overall objectives of the President’s Council for Sports, Fitness, and Nutrition and how they have evolved since the 1960’s. The scope of the council’s work has expanded to include an active lifestyle, importance of nutrition, tobacco avoidance, and renewed focus on sports.
• The council is reauthorized every 2 years and its priorities and the specific functions of council members are outlined. In March 2023 the full council was appointed by the administration.
• Current key priorities include national strategy on hunger, nutrition, and health (and its five pillars and roadmap). In June 2023 the council will finalize its priorities for the next two years.
• SDRAB discussed how sleep fits into the council’s work:
  • sleep and cardiovascular health, physical activity recovery, the timing of meals.
  • research results and data may be used for integration of sleep into the council’s work
  • planned activity around well-known pubic sleep events (e.g. world sleep day, etc.) may be an easy entry and could include blogs by council members, sleep challenge by children and their parents, etc.
  • relationship between obesity and sub-optimal sleep, known to be even stronger in children than in adults; sleep is an urgent and valid priority for addressing obesity particularly for children
  • the issues of daylight saving time, the movement to start school later, and the role of public schools in health
  • discussing athletics and how significant performance boosts are achieved as an exemplar of sleep health for the public

PUBLIC COMMENTS

• There were no public comments.

SDRAB MEMBER DISCUSSION

Lead by Dr. Gabriel Haddad

• SDRAB had an extended discussion about the first day presentations. Specific points included:
  • role of cultural changes regarding sleep and circadian health and science
  • development and dissemination of health and research-related guides for use in educating students at all levels about the importance of sleep and circadian health
  • the need to remove barriers to admitting a person may have a sleep disorder that requires professional help in order to receive proper treatment
  • importance of tailoring interventions to specific populations

The meeting adjourned at 5:00 PM

DAY 2

BOARD MEMBERS PRESENT
Dr. Gabriel Haddad, Chair
Dr. Josiane Broussard
Dr. Si Baker-Goodin
Dr. Jeffery Durmer
Dr. Erik Herzog
Ms. Ebony Lay
Dr. Shaun Purcell
Dr. Tom Scammell
Dr. Esra Tasali
Ms. Alexandra Wharton

BOARD MEMBERS ABSENT
Dr. Alberto Ramos

EX OFFICIO MEMBERS PRESENT
Dr. Marishka Brown, NHLBI, Executive Secretary
Dr. Shahla Jilani
Dr. Karen C. Lee
Dr. Miroslaw Mackiewicz
Dr. Donald Shell

FEDERAL EMPLOYEES
Eight Federal employes attended the meeting in person and 22 were in attendance via Zoom.

MEMBERS OF THE PUBLIC
One member of the public attended the meeting in person and 69 were in attendance via Zoom (including researchers, clinicians, patients, and other stakeholders).

CALL TO ORDER

Marishka Brown, Ph.D.

• The executive secretary called the meeting to order at 9:00 AM ET as announced in the Federal Notice [FR Doc. 2023-05400] published on March 16, 2023; Amended Notice [FR Doc. 2023-06085], March 27, 2023. 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.
• The SDRAB chair asked members introduced themselves and provide their backgrounds, expertise, interests and activities.

OPENING REMARKS

Gustavo Matute-Bello, M.D., Deputy Director, Division of Lung Diseases, NHLBI

• Dr. Matute-Bello expressed his appreciation for the leadership of the NCSDR director and her staff, and the SDRAB chair and members. He described his own interests and background related to the sleep field and expressed the importance of sleep and circadian research for many areas of health.
• The relevance of sleep and circadian science for lung diseases was delineated, highlighting how that relationship will continue to inform shared research and activities going forward. He noted similar integration and opportunities exist within other branches at the NHLBI and will continue to inform NHLBI support and activities.
• The biology of sleep and circadian disorders needs to be better understood, including biomarker development, risk detection for disorders early in life, effective strategies to address the risk, better treatments and cures, and enhanced implementation of the science for all populations with equity.
• The NIH and the federal government need the SDRAB to guide and inform sleep and circadian opportunities and activities both now and in the future.

DISCUSSION/ACTION ITEMS FROM DAY 1

• SDRAB take-aways from the first day included the following:
  • need to enhance the training pipeline in sleep and circadian research
  • relevance of sleep and circadian health and disorders (e.g. sleep deprivation) to obesity and society in general (e.g. school start time, ADHD, autism) and the importance of continued  research to illustrate the relationships more concretely and heighten awareness
  • elevate awareness about sleep health and sleep disorders and their relationship to overall societal health was highlighted as important potential activity
  • need for cultural paradigm shift concerning the important and societal (vs. personal) relevance of sleep and circadian health and disorders
  • the need for sleep issues to be broadly viewed as modifiable risk factors for societal and personal health
  • more creative sleep and circadian health outreach that integrates social media and modern means of information consumption and learning need to be broadly realized to affect diverse populations
  • intervention studies and activities to extend and enable optimal sleep as a means of facilitating weight loss are needed and would likely have the impact of minimizing risk
  • the impact of sleep health and role of hormones on appetite are both significant considerations in obesity
  • it is important to determine how to best communicate with the public and provide information that will be used

NIH-WIDE PROGRAMMATIC UPDATES

Yih-Woei Fridell, Ph.D.
Health Science Administrator, Cell Biology Branch, Division of Aging Biology, National Institute on Aging (NIA)

• Dr. Fridell spoke on two topics:
  • Dietary Composition, Time-Restricted Feeding and Associated Metabolic Reprogramming Workshop Highlights
  • Planning Projects for Clinical Trials on Effects of Sustained Reductions in Caloric Intake and Related Dietary Practices in Younger and Older Persons.
• The presentation began with an overview of the biological basis of circadian synchrony and nutritional status, the relationship to obesity and metabolic syndrome, role of high-fat diet, role of meal timing, and impact of circadian timing of food intake on weight gain.
• Dr. Fridell summarized factors for aligning mealtimes to live longer and described a recent workshop that examined research on dietary composition, time-restricted feeding and associated metabolic reprogramming in health span and longevity regulation.
• A NOFO to support research in this area has been issued and 5 research grants have been awarded and research is ongoing. Details of current clinical trials about dietary approaches to longevity and health were provided, including their designs and methodologies.
• Following the presentation, SDRAB discussed:
  • the gut microbiome and its potential relationship to chrono nutrition
  • cultures that fast intermittently during certain periods (e.g. one month per year)
  • integration of sleep quality or timing with chrononutrition research
  • bidirectionality and the effect of diet on sleep
  • details of animal research and the translation to humans
  • role of internal personal circadian clock
  • whether time of feeding data should be added to and included in publicly available datasets
  • addition of relevant animal data from NIA to the NSRR
  • how the upcoming NCSDR workshop on chrononutrition will differ from the NIA workshop

NHLBI CATALYZE PROGRAM

Mike Pieck, Ph.D.
Scientific Director, NHLBI Catalyze Program

• Dr. Pieck described the mission of the CATALYZE program, the challenges of translational research, and provided the history of prior related programs at NHLBI.
• The strategy of CATALYZE is to provide funding, a coordinated approach, individualized support, and program flexibility across all required areas and phases of work, from product definition, to non-clinical refinement, to first in human, to initial development.
• The differences between CATALYZE and the SBIR/STTR mechanisms were described and it was noted that CATALYZE is generally more flexible and NOFOs cover enabling technologies, small molecules and biologics, and devices and diagnostics. Details of what a CATALYZE awardee can expect (activities and timelines of meetings and communications with the NIH) were described.
• The recently launched preclinical program was highlighted and three specific examples of funded sleep-related technologies currently in CATALYZE were presented.
• SDRAB discussed applicability of CATALYZE for drug repurposing, exclusionary criteria for support by the CATALYZE program, and assessment of the makeup of applicant teams (e.g. industry collaborating with academics).

SCIENTIFIC FOCUS PRESENTATION

Martha Gillette, Ph.D.
Alumni Professor of Cell & Developmental Biology
Professor of Molecular & Integrative Physiology
University of Illinois Urbana-Champaign

• Dr. Gillette described her trans-agency blood-brain interface program phased award to study dynamic circadian regulation of the blood-brain interface (BBI) in a human brain-mimicking microfluidic chip that began work 18 months ago. The anatomic and structural overview of the BBI were described, with the current program goal of developing an in vitro human BBI model that recapitulates circadian rhythm-controlled trans-vascular transport of bioactive molecules.
• Physiologic changes over the 24-hour circadian cycle were summarize, with emphasis on blood pressure changes and their relevance to stroke. Understanding the endogenous oscillations in blood-brain interface permeability is an unmet need for research.
• There are similarities in deposition of fibrinogen in Alzheimer’s disease and traumatic brain injury. The hypothesis of this mechanism and the multidisciplinary research team was described, and the support of the research by both NHLBI and the DOD was highlighted. Current preliminary results and data were shared.
• SDRAB expressed its enthusiasm for this innovative research and discussed circadian rhythmicity for microbleeds in strokes, potential uses of the tool under development to further study effect of sleep deprivation on the nervous system, potential for use in further research about the glymphatic channels/system in sleep vs. wake states, and further potential translational/clinical works.

UPDATES FROM STAKEHOLDER GROUPS

National Sleep Foundation (NSF)
Joe Dzierzewski, Ph.D.,Vice President, Research and Scientific Affairs
John Lopos, Chief Executive Officer

• The speakers described the NSF’s mission and goals, distinctive research tools, annual campaigns, and thought leadership. NSF research focuses on the key areas of sleep technology, sleep health and public safety, and global sleep health. Examples of published research and guidelines, position statements, consumer device standards, advocacy and education activities, and data about public outreach during Sleep Awareness Week 2023 were provided.
• External data trends show the public is increasingly looking for information about sleep health and sleep disorders, and NSF’s internal data show widespread public education needs for addressing and improving sleep health among Americans.
• The background and methodology of NSF’s most recent research focus to study the link between sleep and mental health were provided. Results show disparities in the nation’s sleep and mental health, healthy sleep is associated with lower rates of depressive symptoms, and difficulty falling asleep just two nights a week is associated with higher depressive symptoms.
• SDRAB discussed how the NSF is funded, how it decides on its work priorities, the NSF data on the nation’s sleep health and sleep satisfaction, the disparities that have been observed, and the foundation’s plans for tailored messaging for the groups most at risk.
• Overlap with other programs and enriched data (e.g. Healthy People 2030, and CDC) and joint efforts to better and more concretely collaborate for sleep health were also discussed. The role of NCSDR and the larger HHS community for development of Healthy People 2030 output was highlighted.
• Finally, SDRAB noted the successful purposeful actions of NSF for translating research and science into effective and accurate messaging for the public, and expressed this is an important area that should continue.

PUBLIC COMMENTS

• There were no public comments.

SDRAB MEMBER DISCUSSION
Lead by Dr. Gabriel Haddad

• The board discussed current relevant discoveries and research. Lunar gravitational influence and other cues beyond light for circadian rhythm issues were highlighted as potential topics for expanded research, as was studying the effects of circadian health during pregnancy on the health of the offspring.
• The board issued the following recommendations for further work by the sleep and circadian research and related communities:
  • research on physician attitudes about their own and their patients’ sleep across several career stages including beginning/end of medical school and later during practice
  • encourage partnerships between researchers and science writers to create more effective communication and education utilizing modern practices
  • raise public awareness about sleep disorders and sleep culture by working more closely with the NSF and other relevant partner organizations

UPCOMING EVENTS/CLOSING REMARKS

• The chair thanked the board and expressed that it has been his honor to serve. He thanked NCSDR and its director who is full of energy and dedication and welcomed the incoming chair of SDRAB.
• The NCSDR director thanked all board members including the outgoing chair and board members for their passion and inspiration and for enabling all board members to speak with compassion.
• The next meeting is August 3, 2023 and will be fully virtual.

The meeting adjourned at 2:00 PM