The purpose of this 2-day hybrid meeting was to seek guidance and gather input from the Sleep Disorders Research Advisory Board on research priorities conducted or supported by the Institute; and to discuss topics for the NIH Sleep Research Plan refresh. The meeting agenda appears below and the meeting minutes appear below.

Meeting Summary

DAY 1

BOARD MEMBERS PRESENT
Dr. Esra Tasali, Chair
Mr. David Bishop
Dr. Josiane Broussard
Dr. Paula Desplats
Dr. Jeffery Durmer
Dr. Dayna Johnson
Dr. Pat McBride
Dr. Alberto Ramos

BOARD MEMBERS ABSENT
Dr. Shaun Purcell

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

AD HOC PARTICIPANTS
Dr. Sara Aton
Dr. Erik Herzog
Ms. Alexandra Wharton

FEDERAL EMPLOYEES
Eight Federal employes attended the meeting in person and 38 were in attendance via Zoom.

MEMBERS OF THE PUBLIC
Seven members of the public attended the meeting in person and 78 were in attendance via Zoom (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 [FR. Doc. 2025 - 10538 ] on June 11, 2025. 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.
• Dr. Brown introduced the Chair of SDRAB, Dr. Esra Tasali.
• The Chair welcomed everyone and asked members to introduce themselves.

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

• Dr. Brown acknowledged the contributions of Erik Herzog and Alexandra Wharton whose terms as SDRAB members had recently expired but who were participating in the meeting as ad hoc members. She also welcomed two new members of the Board, Mr. David Bishop and Dr. Pat McBride.
• Dr. Brown shared the published vision and the priorities of the new NIH director Dr. Jayanta (Jay) Bhattacharya and indicated the alignment of sleep and circadian research to these new priorities.
• Dr. Brown outlined the purpose of the SDRAB, the establishment of the NCSDR and highlighted a few historical accomplishments of the NCSDR and SDRAB, including the landmark Sleep Heart Health Study, the addition of the Sleep Health topic in HHS Healthy People, and the publication of NIH-wide Sleep Research Plans, the most recent being from 2021.
• Dr. Brown noted that sleep, diet, and physical activity comprise a triad of modifiable behaviors that serve as key pillars of optimal health and well-being, and sleep is as much of a biological necessity as air and water.
• The NCSDR vision is to facilitate the integration of sleep, with physical activity and nutrition, as a constant and enduring pillar of all health promotion and disease prevention programs.
• Dr. Brown outlined changes that occurred within NCSDR and NIH recently, specifically the loss our administrative support and a program officer in 2025 leading to many operational challenges within the Center.
• The centralization of the Center for Scientific Review (CSR) and what this potentially means for applicants was noted.
• Dr. Brown discussed some of the new policies and notices of importance to the community, including:
  • Continued Eligibility for Mentored Career Development Award When an Award Ended Early
  • Temporary Extension of Eligibility for K99/R00
  • Updated NIH Policy on Foreign Subawards
  • Supporting Fairness and Originality in NIH Research Applications
  • Request for Information on Maximizing Research Funds by Limiting Allowable Publishing Costs
• Following a brief Q&A regarding the director’s report, Dr. Brown transitioned to discuss the NIH-Wide Sleep Research Plan refresh.
• The necessity of optimal sleep is evidenced by its incorporation into health metrics for prevention of cardiovascular disease (Life’s Essential 8) and clinical practice guidelines for obesity in children and adolescents, and management of diabetes care.
• The American Heart Association (AHA), American Diabetes Association (ADA), and American Academy of Pediatrics (AAP) all adopted sleep health into their clinical guidelines for preventing and treating chronic disease.
• There are scientific opportunities in the life course approach, beginning with the developmental trajectory, from birth to older adults, while focusing on prevention and optimizing sleep health.
• Funding for sleep and circadian research NIH-wide has been growing steadily over the past decade and is supported broadly.
• SDRAB input was sought on four proposed research topics for the Sleep Plan Refresh :
  • Innovating Diagnostics and Treatments for Sleep and Circadian Disorders
  • Sleep and Circadian-Based Strategies for Prevention and Mitigation of Chronic Disease
  • Sleep and Circadian Rhythms in Development, Child, and Adolescent Health
  • New Approach Methodologies in Sleep and Circadian Research

TOPIC 1 OVERVIEW
Innovating Diagnostics and Treatments for Sleep and Circadian Disorders

Marishka Brown, Ph.D., Director, NCSDR

• Sleep and circadian biology research are experiencing a period of rapid innovation, driven in part by advances in diagnostics and digital health tools.
• Improvements in existing diagnostics and development of new tools to collect a large amount of information related to the state of the individual, offer new opportunities for earlier and more accurate diagnoses.
• Advances in genomic and molecular research have enabled a deeper understanding of bio-signatures unique to individual sleep disorders, which aim to inform treatment strategies based on underlying biology, supporting a shift toward personalized treatment.

SDRAB MEMBER DISCUSSION – TOPIC 1
Moderated by Dr. Esra Tasali
Summary of Discussion and Future Directions

• A state-of-the-science symposium with the research community, stakeholders, and patients to examine the current landscape of sleep endotypes/phenotypes and establish a roadmap for advancing precision sleep medicine, including predicting patient response to treatments.
• Develop next-generation adaptive devices (upper airway neurostimulators, auto-titrating CPAPs) that respond in real-time to individual patient endotypes and physiology to improve therapeutic efficacy and move toward personalized, combinatorial treatment approaches.
• Invest in workforce with emphasis on training sleep researcher programmers equipped with big data, AI/ML, and algorithm development skills to match the amplified data collection from wearable technologies.
• Integrate sleep data with broader health metrics (cardiometabolic, continuous glucose monitoring, etc.) to implement sleep and circadian research into public health practice and help patients understand the connections between sleep and their other health outcomes.
• Establish AI validation and regulatory frameworks that balance rapid technological advancement with patient safety, data integrity, and privacy protection, while addressing concerns through adequate recruitment of diverse populations to prevent algorithmic bias.
• Create clinical implementation pathways to rapidly translate research findings (into clinician hands.
• Expand chronodiagnostic research to increase awareness of time as a biological variable across the biomedical research community, recognizing that diagnostic accuracy varies with time of day and applying cross-disciplinary methods (such as the four core genotypes model from cancer research) to sleep and circadian biology.

STAKEHOLDER GROUP UPDATE – American Thoracic Society – Sleep and Respiratory Neurology (ATS-SRN) Assembly
Klar Yaggi, M.D., M.P.H., Director, Yale Center for Sleep Medicine, Representing the ATS-SRN Assembly

• Dr. Yaggi gave an overview of the mission, history, and membership of the ATS
  • The American Thoracic Society (ATS) is dedicated to accelerating global innovation in the advancement of respiratory health through multidisciplinary collaboration, education, and advocacy.
• The ATS is organized into a dozen or so subdivisions called Assemblies composed of members and affiliates with like interests within the broad fields of respiratory disease, and critical care medicine.
  • Sleep is largely discussed and conducted in the Sleep and Respiratory Neurobiology (SRN) Assembly.
• The SRN has a basic research framework for investigating sleep disordered breathing (SDB)
• Dr. Yaggi then shared the research priorities of the SRN:
  • Address SDB and sleep deficiency as treatable factors in the progression of common chronic disease by focusing on:
    • Cardiovascular/Cardiometabolic Disease
    • Investigate Sleep–Pulmonary Disease Overlaps
    • Opioid Use Disorder
  • Harness advanced methods to enable personalized approaches in clinical care
    • Validate physiological endotypes across diverse populations
    • Determine the stability of endotypes and molecular profiles across repeated assessments and therapeutic exposures
    • Link endotypes to symptoms, function, treatment response, and outcomes
    • Examine how symptom phenotypes modify risk and outcomes
    • Examine sex differences
    • Apply ML to multimodal data
    • Incorporate wearable sensor data to determine digital phenotypes that can be linked to omics and outcomes
  • Pharmacotherapy for SDB
    • Leverage established mechanistic framework
    • Evaluate the therapeutic efficacy and safety of pharmacotherapies in vulnerable populations with limited treatment options or poor PAP tolerance
    • Public-private partnerships for therapeutic discovery and translation
  • Foster methodologic advancements to drive innovation in clinical research
    • Advance measurement and research of patient-reported outcomes (PROs) in SDB
    • Establish a Sleep Research Network to accelerate discoveries through multi-center longitudinal clinical studies in larger populations
• Research priorities in other populations at risk for sleep-related dysfunction or that may benefit from sleep interventions:
  • Determine the role of disrupted sleep and circadian misalignment on short- and long-term outcomes among critically ill patients
  • Investigate the use of therapeutic intermittent hypoxia to enhance neural plasticity and functional recovery in patients with conditions such as motor recovery post-stroke, respiratory muscle function in spinal cord injury, and ALS.
• Dr. Yaggi ended his presentation by recommending the recent paper The Mitochondrial Origins of Sleep Pressure which goes back to basic biology to show that the energy factories in our cells are sensitive to sleep patterns and circadian rhythms; thus sleep is not just a behavioral phenomenon.

STAKEHOLDER GROUP UPDATE – National Sleep Foundation (NSF)
John Lopos, CEO

• John Lopos began his talk by explaining that the National Sleep Foundation (NSF) is not a membership organization or a clinical organization but a public health organization that serves the public through its sleep health mission and goals. The NSF is dedicated to improving health and well-being through sleep education and advocacy.
• The NSF’s work is driven by 4 goals:
  • Sleep health is accepted as a crucial measure of overall health
  • The natural sleep/wake process is understood as the basis for healthy sleep
  • Community, infrastructure, and environments respect sleep health
  • Sleep science and insight are rapidly incorporated into accessible health products and services
• The NSF is the public’s most established sleep health resource and the first organization solely dedicated to public sleep health and well-being.
• Their public focus puts NSF at the center of sleep collaborators, connecting and supporting like minds and missions and lending credibility and trust from their independence.
• Mr. Lopos described NSF’s Best Slept Self consumer-friendly framework that includes evidence-based tips for both daytime and nighttime best practices to support good sleep hygiene.
• NSF supports the translation of science, data, and insights into recommendations for healthy sleep behaviors in the form of educational materials that the public can internalize. This is done through published research, guidelines, and standards, in their peer-reviewed journal Sleep Health and other channels.
• The Foundation has also worked with the consumer Technology Association to develop standards in the sleep tech space for consumer wearables.
• Mr. Lopos ended his presentation by sharing a brief sample of NSF findings from their most recent Sleep in America poll.

TOPIC 2 OVERVIEW
Sleep and Circadian-Based Strategies for Prevention and Mitigation of Chronic Disease
Shilpy Dixit, Ph.D., Program Director, NIH NHBLI

• Sleep deficiency and circadian misalignment are significant public health and economic concerns and are closely tied to chronic diseases and social determinants of health.
• Sleep and circadian-based strategies play a vital role in both the primary and secondary prevention of chronic disease by supporting physical health and psychosocial well-being, especially when combined with other modifiable behaviors, such as physical activity and diet.
• Recent findings underscore the preventative potential of interventions such as consistent sleep timing to reduce cardiovascular risk, early time restricted eating to improve cardiometabolic markers, and morning physical activity to increase insulin sensitivity and reduce blood pressure.
• Even the timing of certain medications and behavioral interventions may significantly influence the efficacy and preventive outcomes of those interventions.
• Despite strong evidence, challenges and knowledge gaps hinder large-scale implementation, limiting the transformation of these findings into widespread public health solutions.

SDRAB MEMBER DISCUSSION – TOPIC 2
Moderated by Dr. Esra Tasali
Summary of Discussion and Future Directions

• Develop and implement culturally tailored sleep interventions that account for within-culture variance and leverage observational research to provide solution-oriented approaches to address sleep disparities in communities disproportionately affected by circadian disruption and poor sleep health.
• Support standardized research in chronotherapy into drug development and clinical trials by analyzing failed Phase III trials through the lens of circadian timing, leveraging existing gene expression datasets to identify optimal administration times for therapeutic compounds.
• Bridge the translation gap between laboratory findings and real-world implementation through qualitative research that identifies barriers to adoption and informs practical strategies for sustained behavioral change beyond intervention studies.
• Prioritize early-life sleep health by anchoring good sleep habits during pregnancy, childhood, and adolescence as a foundation for chronic disease prevention across the lifespan.
• Focus research on achieving sustained behavioral change by collaborating with behavioral scientists to develop motivational strategies and leverage wearable technology feedback that translates data into long-term adoption of healthy sleep and circadian behaviors.

STAKEHOLDER GROUP UPDATE #3 – Sleep Research Society (SRS)
Dan Buysse, M.D., Chair, University of Pittsburgh Center for Sleep and Circadian Science, Representing the SRS

• Dr. Buysse informed the audience that the Sleep Research Society (SRS) is a membership organization comprising scientists and trainees who investigate sleep and circadian science.
• The SRS mission is to advance sleep and circadian science to cultivate knowledge and to optimize health and well-being (and reduce chronic disease burden).
• The central focus is to grow and foster a collaborative, collegial sleep and circadian research community.
• Dr. Buysse outlined SRS initiatives and priorities in 2025 and beyond.
• Dr. Buysse emphasized that in all SRS initiatives, the NCSDR has been an essential partner by:
  • Coordinating across NIH Institutes and other sleep research funding entities
  • Embodying the relevance of sleep and circadian rhythms across health, disease, and systems
  • Supporting the full translational spectrum
  • NCSDR strategic plan is a road map that guides the work of the SRS
  • NCSDR and SDRAB integrate input from multiple scientific and public stakeholders

PUBLIC QUESTIONS/COMMENTS

• Peter Mansbach, president and founder of the Circadian Sleep Disorders Network (CSDN) commented while some providers are sharing information about the need for adequate and timely sleep, there is limited understanding that some individuals have circadian disorders that alter what their sleep “norms” are/should be.
• Monica Mallampalli, Ph.D. president and CEO of the Alliance of Sleep Apnea Partners (ASAP) shared the following:
  • Sex differences are very important and there is a need to pay more attention to the health of women with OSA.
    • For example, what is the role of hormones and hormone replacement therapy (HRT)?
    • Why are we underdiagnosing women with OSA? We know the clinical presentation is different; what about the pathophysiology?
  • Regarding the discussion about personalized treatment, we need to make the distinction between personalized and precision. Precision medicine focuses on using an individual’s molecular and genetic information to tailor treatment whereas personalized medicine considers factors beyond genetics, such as lifestyle and environment. She encouraged SDRAB to consider the need for new biomarkers.
  • There appears to be a strong connection between OSA and chronic diseases including other sleep disorders and more mechanistic studies are needed in this areas.
  • There was mention of an inflection point. There is a dearth of research of the prevention of OSA. Yes, it is complex, but can it be prevented in certain populations?
  • There needs to be more research on insomnia and chronic pain.

CLOSING REMARKS

• Dr. Tasali noted that sleep being included in the Make America Healthy Again (MAHA) report is not surprising as sleep and circadian systems are integral to health. If we want a healthier next generation and to decrease chronic disease, there must be more research in this area, particularly focusing on strategies to optimize sleep.
• There is an exciting opportunity to refresh the Sleep Research Plan to find ways to leverage technology, implement multidisciplinary approaches, and move forward with personalized, optimized, culturally tailored interventions to improve sleep health.
• The important role of NCSDR and SDRAB in serving multiple key purposes:
  • The refresh of the Sleep Plan serves as a roadmap for new, high priority research ideas.
  • Sleep and circadian research are multidisciplinary and NCSDR serves as a coordinating body that brings together diverse disciplines, agencies, healthcare sectors, and public stakeholders.
  • NCSDR is also crucial in the support of training programs.

The meeting adjourned at 5:00 PM ET

DAY 2

BOARD MEMBERS PRESENT
Dr. Esra Tasali, Chair
Mr. David Bishop
Dr. Josiane Broussard
Dr. Paula Desplats
Dr. Jeffery Durmer
Dr. Dayna Johnson
Dr. Pat McBride
Dr. Alberto Ramos

BOARD MEMBERS ABSENT
Dr. Shaun Purcell

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

AD HOC PARTICIPANTS
Dr. Sara Aton
Dr. Erik Herzog
Ms. Alexandra Wharton

FEDERAL EMPLOYEES
Five Federal employees attended the meeting in person and 44 were in attendance via Zoom.

MEMBERS OF THE PUBLIC
Three member of the public attended the meeting in person and 56 were in attendance via Zoom (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 9:00 AM ET as announced in the Federal Notice [FR. Doc. 2025 - 10538] on June 11, 2025. 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 Chair welcomed everyone and SDRAB members introduced themselves.

RECAP OF DAY 1 / INTRO TO DAY 2

• Dr. Tasali summarized the presentations and discussions from the first day.

TOPIC 3 OVERVIEW
Sleep and Circadian Rhythms in Development, Child, and Adolescent Health
Lameese Akacem, Ph.D., Program Director, NIH NIGMS

• Sleep health is a critical pillar of health across the lifespan. However, the window from preconception to early childhood and even into the adolescent years represents an especially sensitive window where sleep health can impact overall health trajectory as well as the possible development of chronic health conditions later in life.
• Sleep in infancy and early childhood:
  • Developmental phase marked by significant changes in sleep patterns.
  • Young children undergo many transitions in sleep patterns, from napping multiple times per day to not napping at all.
  • Environmental factors influencing sleep include parent-selected sleep times, daycare/preschool schedules, and electronic media use.
  • Adequate sleep at this stage is critical for healthy development as sleep impacts physical growth, cognitive function, and emotional well-being. When these sleep needs are not met, there can be severe consequences.
  • Sleep deficiency and circadian misalignment may trigger the early onset of pathophysiological mechanisms involved in the etiology of chronic disease, including obesity, diabetes, and depression.
• Sleep in school-age children and adolescents:
  • Many environmental factors influence sleep during this phase, including academic demands, social pressures, participation in extracurricular activities, and technology use. These are all things that can constrict the sleep window.
  • Prominent changes in circadian timing: adolescent phase delay. This phase delay coupled with the environmental factors creates a perfect storm for insufficient sleep in this age group.
  • Chronic insufficient sleep during this phase of development is associated with concurrent and future chronic health issues including mental health problems, obesity, and diabetes.
  • Sleep deficiency and circadian misalignment may be a contributing factor in the public health trend of chronic diseases appearing earlier in life.
• Opportunity highlight: Sleep at the intersection with maternal/fetal health
  • Development of the circadian system begins in utero
  • Emerging epidemiologic and basic research suggests that maternal sleep deficiency and circadian misalignment have potential adverse effects on fetal development.
  • Pregnant women are particularly vulnerable to sleep problems. Sleep disordered breathing and insufficient sleep are common during pregnancy.
  • Prenatal sleep problems are associated with negative health outcomes for both mother and child such as low birth weight, premature labor, and offspring obesity later in life.

SDRAB MEMBER DISCUSSION – TOPIC 3
Moderated by Dr. Esra Tasali
Summary of Discussion and Future Directions

• Prioritize maternal/fetal sleep research - Expand beyond metabolic and cardiovascular outcomes to study neurological consequences of circadian disruption in utero, particularly during critical myelination periods, and develop screening tools for sleep-disordered breathing in pregnancy.
• Develop and test scheduled exercise interventions - Translate findings from animal model on exercise as a circadian zeitgeber into controlled clinical trials to determine optimal timing for exercise across different populations and its effects on sleep, cognitive performance, and other health outcomes in children and adolescents.
• Implement multimodal school-based interventions - Comprehensive programs involving children, parents, and school administration that address the bidirectional relationship between diet, activity, and sleep, potentially incorporating food timing, wearable feedback, and delayed school start times.
• Investigate environment impacts on adolescent mental health - Study how rising temperatures affect sleep and whether sleep mediates the relationship between heat and mental health outcomes, including seasonal patterns in adolescent suicide rates.
• Advance sleep quality measurement through autonomic nervous system metrics - Develop standardized, objective measures of sleep quality using photoplethysmography sensors in wearables to capture heart rate variability, autonomic fluctuations, and sleep fragmentation beyond traditional polysomnography.
• Explore circadian interventions for neurodevelopmental conditions - Investigate circadian rhythm modulation in neurodevelopment conditions, including, but not limited to, ADHD, autism, Down syndrome, and restless leg syndrome, including whether improving sleep can benefit cognition and neurodevelopment, and determine when circadian alignment versus disruption may be therapeutic.
• Create targeted early intervention programs for at-risk infants - Develop evidence-based interventions for mother-infant dyads, specifically for mothers that had significant sleep disruption during pregnancy and establish risk/benefit ratios for early sleep interventions.
• Leverage existing cohorts with enhanced sleep phenotyping - Encourage the use of existing cohorts, such as HBCD, ABCD, RURAL, and other NIH cohorts with harmonized data, incorporating deep phenotyping and novel biomarkers of developmental brain and metabolic age to establish causal relationships through longitudinal study designs.
• Study environmental modifications as sleep interventions - Investigate housing quality, weatherization programs, indoor temperature control, and light exposure as modifiable factors affecting sleep health, using home sensors combined with wearables to assess real-world physiological disruptions.
• Understand mechanisms through translational animal models - Supporting basic mechanistic research using animal models to understand how maternal sleep disruption affects sleep regulatory circuitry development in offspring, enabling more targeted interventions during critical developmental windows.

STAKEHOLDER GROUP UPDATE – American Academy of Sleep Medicine (AASM) 
Anita Shelgikar, M.D., MHPE, President AASM

• Dr. Shelgikar shared that the American Academy of Sleep Medicine (AASM) is a professional society for anyone who is involved in the field of sleep medicine.
• The AASM Strategic Plan supports the Academy’s mission of advancing sleep care and enhancing sleep health to improve lives.
  • Vision - sleep and circadian care is fundamental to health care. This statement emphasizes that the work their members do every day that is vital and foundational for the success of our health care system.
  • Mission - advancing sleep care and enhancing sleep health to improve lives
  • Strategic goals:
    • Sleep medicine awareness, by which they engage in advocacy to promote the value of sleep medicine
    • Practice success, by which they ensure that sleep practices in diverse settings can deliver quality care and innovate to achieve better outcomes for patients
    • Technology integration, by which they guide sleep team professionals in integrating new and emerging technologies in clinical care
• The AASM is also advancing several strategic initiatives to address current challenges in the field. Dr. Shelgikar highlighted several including :
  • Re-Envisioning Adult OSA Characterization
  • Obesity Management
  • Patient-reported Longitudinal Assessment Tool for OSA (PLATO)
    • Paper published in Journal of Clinical Sleep Medicine (JCSM)
  • Women’s Sleep Health Task Force
  • Sleep is Good Medicine public awareness campaign
  • Patient Advocacy Roundtable
    • Partnering with patient organizations to advance shared goals
    • Advocating together for patients who have sleep disorders
    • Collaborating to raise awareness
    • Increasing the patient voice in AASM initiatives
  • Sleep & Student Health
• A key component of the Academy’s mission is to develop and publish practice standards for the practice of sleep medicine. These papers are essential documents for the sleep field, and they are made publicly available on the websites of the AASM and the JCSM.
  • Position Statement: Clinical Significance of Sleepiness
• Dr. Shelgikar ended her presentation by giving an overview of the AASM Foundation. Founded in 1998, it is a not-for-profit charitable and scientific organization that has invested in the future of sleep medicine.

TOPIC 4 OVERVIEW
New Approach Methodologies in Sleep and Circadian Research - Leveraging Innovation to Advance Sleep & Circadian Research
Dana Schloesser, Ph.D., Program Director, NIH OBRRS

• Dr. Schloesser began by asserting AI and big data approaches have the potential to revolutionize sleep and circadian research by enabling large-scale data integration, real-time monitoring, personalized interventions, and predictive modeling of sleep patterns and circadian rhythms.
• Convergence of AI with wearable devices and increased access to genomics, neuroimaging, and electronic health records allows for unprecedented precision in diagnosing sleep disorders, understanding chronobiological variation, and tailoring circadian-aligned health interventions.
• New Approach Methodologies (NAMs) are lab or computer-based research approaches intended to more accurately model human biology, and complement, or in some cases, replace traditional research models.
  • Organoids, tissue chips, and other in vitro systems that allow scientists to model human disease and capture human variability and patient-specific characteristics.
  • Computational models which simulate complex biological human systems, disease pathways, and drug interactions.
  • Real-world data that allow scientists to study health outcomes in humans at community and population levels
• As sleep health and the critical role of circadian rhythms increasingly emerge as key pillars of overall well-being and productivity, leveraging AI, Big Data, and NAMs offers a transformative pathway to decipher sleep disorders, complex biological rhythms and their impact on mental and physical health.

SDRAB MEMBER DISCUSSION – TOPIC 4
Moderated by Dr. Esra Tasali
Summary of Discussion and Future Directions

• Establish standardized algorithms for wearable data analysis Collaborations between societies, industry, and resources like NSRR, potentially through annual hackathons to develop open-access analytical tools.
• Leverage industry partnerships to reduce sensor costs by incorporating AI-developed devices into research budgets and exploring service-based models where monitoring services subsidize sensor costs.
• Build pragmatic observational clinical cohorts using advanced wearable technologies, following the model of successful population-based studies like Sleep Heart Health.
• Distinguish and address ethical frameworks for generative AI versus analytical AI, particularly for behavioral interventions, with the sleep community evaluating AI as both a research outcome and intervention target.
• Develop validation criteria for alternative research models (organoids, NAMs)
• Integrate AI into the sleep research framework rather than treating it as a separate tool, with the field taking ownership of generative AI ethics and applications.
• Improve actigraphy algorithms to better reflect true sleep states, addressing the gap between valid motion data and inaccurate sleep estimates.

STAKEHOLDER GROUP UPDATE – Society for Research on Biological Rhythms (SRBR) 
John Hogenesch, Ph.D., Professor of Pediatrics, Cincinnati Children's Hospital Medical Center
Representing SRBR

• Dr. Hogenesch shared that the mission of the Society for Biological Rhythms (SRBR) is to promote research and education in biological rhythms among scientists and the lay public, increase awareness, and advocate for policies that improve health by taking rhythms into account.
• The activities include:
  • Host a biennial conference that is the largest in the field
    • Research has largely been focused on basic mechanisms and physiology in organisms ranging from cyanobacteria to humans. Four members have been awarded Nobel prizes for elucidating the molecular mechanism of the clock.
    • Current research emphasis is on translation – moving basic discoveries into the clinic.
  • Support the Journal of Biological Rhythms
  • Support many educational and training activities
• Dr. Hogenesch shared how the SRBR is responding to the NIH Sleep Research Plan
  • Continued support for mechanistic studies of circadian clocks
  • Seek ways to improve sleep and circadian rhythms, and test their role in disease risk and progression
  • Efforts to move circadian biology to the clinic
  • Seek new measures of sleep quality and circadian misalignment
  • Seek multi-center trials and collaborations, emphasizing sleep in field-conditions
• Dr. Hogenesch concluded his presentation with a discussion of important next steps for the field
  • Standardizing methodology for circadian research across circadian/sleep societies worldwide – e.g. actigraphy, molecular diagnostics

REMARKS FROM NHLBI – Division of Lung Diseases (DLD)
Gustavo (Gus) Matute-Bello, M.D., Acting Director, NIH NHLBI DLD

• Dr. Matute-Bello thanked the SDRAB for their time and contributions to NCSDR and NIH, and he assured the group that sleep disorders and circadian biology remain important priorities for the NHLBI.
• Through NCSDR, NHBLI continues to identify opportunities and collaborative platforms that deepen our understanding of sleep’s impact on health and to drive this research to NIH collaboration as well as across the federal government and nationally.
• With the advancement of AI/ML there are vast opportunities to utilize data generated by multiple resources. These data are being leveraged to:
  • Probe the genetic underpinnings of sleep and circadian disorders, gain insights into the influence of sleep behavior on pulmonary, cardiovascular, neurodegenerative, and other sleep health outcomes
  • Investigate the epidemiology and pathobiology of sleep and circadian disorders across different populations
  • Develop prediction models for more effective therapies for sleep disorders, which are much needed
• NHLBI funded research served as the basis for the AHA’s addition of sleep as a component of their Life’s Essential 8 campaign, underscoring the importance of sleep and chronic conditions such as heart disease. This serves as an example of how the research community and science can together foster public health.
• There are also significant disparities in sleep in women and girls and this is an active area of research interest.
• Research has clearly shown that sleep is a critical factor in health promotion and in disease prevention.
• Dr. Matute-Bello emphasized that the SDRAB members’ representation of the sleep and circadian research communities in this forum is significant. He encouraged SDRAB to use this meeting venue as a means of exchanging information, identifying priorities, and offering feedback because NIH needs to hear what they have to say.
• Dr. Matute-Bello ended his remarks by thanking Dr. Marishka Brown and the NCSDR staff for their exemplary leadership which makes the successful implementation of the NIH Sleep Research Plan possible.

PUBLIC COMMENTS

• These discussions are highly in line with the military as well. Commander Kent Warner, MD, PhD who represents the Navy for sleep, shared current activities, such as having their service members have wearables.
• Dr. Bridgette McCullough shared her thoughts and personal experiences with sleep.
  • From infancy through adolescence she made sure her daughter got 10 hours of sleep each night because she knew sleep was foundational to development, healing, and self-worth.
  • She followed the advice she received to sleep when the baby slept.
  • As a cancer patient, Dr. McCullough was told by her surgeon that she needed to sleep in order for her body to recover and heal itself.
  • Sleep is not indulgent, it’s imperative. Rest is not weakness, it’s medicine. Healing requires more than procedures; it requires rest and time.
  • She thanked the Board for recognizing sleep as not just a variable but as an ethical necessity.

OPEN DISCUSSION ABOUT PROPOSED SLEEP PLAN TOPICS
Moderated by Dr. Esra Tasali

The Board agreed with the four topics and recommended them for inclusion in the Sleep Plan refresh. Their overall comments about the topics are as follows:

• Precision was a theme across all discussions, from diagnostic precision to therapeutic precision to inclusion of circadian medicine, which improves precision even further.
• Regarding the precision around SDB diagnostics in women, in clinical practice women with SDB routinely present with no evidence of SDB on a PSG, but their SDB is confirmed as autonomic fragmentation on ANS testing, sympathetic activation in lieu of actual measurements of airway closure. There is an opportunity here, specifically within populations who are underserved by the current diagnostic technologies, to integrate these into more of a longitudinal measure of SDB, which we know has a significant variability from night to night and across different stages of life.
• Sex differences in OSA: defining and diagnosing sleep apnea is excluding women, particularly in home sleep apnea testing. Women tend to have more REM-related sleep apnea that may not meet the AHI threshold for an overall OSA diagnosis, despite having clinically significant respiratory events during REM sleep. Research is moving away from reliance on a single metric.
• Include the concept of value-based behavior change into the sleep plan refresh. Research on how we can create behavior change based on individual value systems individually tailored reasoned as to why an individual can/should make a change.
• There is an opportunity to use AI to elaborate upon an individual's motivations and value systems and then use that as part of the implementation strategy to generate.
• The presence of real opportunities to take the objective wearable data and use AI to analyze it to make new connections. Developing these digital phenotypes is the next step in this field.
• SDRAB recommended a conference on wearables and AI.
• The National Academies of Sciences, Engineering, and Medicine (NASEM) recently published a consensus study report on The Science and Practice of Team Science. The SDRAB recommended a NASEM report for sleep and circadian biology.
• Opportunity to use the longitudinal data collection of wearable, nearable devices, to create profiles, around both sleep and wake, by applying a standardized algorithm to help unravel some of the complexity.
• The benefits of adequate sleep in populations experiencing neuroatypical conditions such as ADHD and autism has a significant impact on neurodevelopment and the association with dopamine systems and adenosine systems. Medication overlap in relation to sleep and wake, is a great area for research focus.
• Sleep and circadian disorders occur across the spectrum of a number of substance use disorders (SUD) and people with DSPD and other circadian disorders are at risk for substance misuse because of self-medicating. This seems like a potentially good target for preventing the development of SUD.
• It's important to have patient participation in the research process to communicate their perspective on what's most meaningful to them in terms of the quality of their day-to-day lives.
• Patients can also point out some of the blind spots they are seeing in clinical practice -- for example, asking how many hours of sleep a patient is getting but not asking when they are sleeping.
• The patient needs to be at the forefront of everything we do.

NEXT STEPS FOR SLEEP PLAN REFRESH /CLOSING REMARKS
Marishka Brown, Ph.D., Director, NCSDR

• NIH will take the feedback from this meeting to help refine the topics discussed and at future meetings we will revisit each topic in further detail.
• After we get consensus from SDRAB we will share the topic with other stakeholders and the broader research community to get their input..
• Our goal is to try to fast track the refresh so that by the end of next summer we can have a draft available for review.

The meeting adjourned at 2:00 PM ET