photo of woman sleeping in bed

NIH Sleep Disorders Research Advisory Board Meeting

Event Details

April 09, 2026 1:00 PM
to
April 10, 2026 2:00 PM

NHLBI
Rockledge Centre I
6705 Rockledge Drive, Room 111 A&B
Bethesda, MD 20892
United States

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Description

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 continue discussions on the topics for the NIH Sleep Research Plan refresh.

MEETING SUMMARY

DAY 1

BOARD MEMBERS PRESENT
Dr. Josiane Broussard, Acting Chair
Mr. David Bishop
Dr. Paula Desplats

BOARD MEMBERS ABSENT
Dr. Pat McBride

AD HOC PARICIPANS
Dr. Daniel Buysse
Dr. Jeffrey Durmer
Dr. Martha Gillette
Dr. Dayna Johnson
Dr. Shaun Purcell
Dr. Esra Tasali
Dr. Wendy Troxel

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

FEDERAL EMPLOYEES 
Ten Federal employes attended the meeting in person and 16 were in attendance via Teams.

MEMBERS OF THE PUBLIC 
Three members of the public attended the meeting in person and 49 were in attendance via Teams (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. 2026-01169 ] on January 22, 2026. 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 Acting Chair of SDRAB, Dr. Josiane Broussard.
  • The Acting Chair welcomed everyone and asked members to introduce themselves and provide their backgrounds, expertise, interests, and activities.

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

  • Dr. Brown outlined the specific mandate and charge of NCSDR
  • Dr. Brown recognized several SDRAB board members who recently rotated off the board and she thanked them for their years of service.
  • She also recognized the 13 years of contributions from Dr. Gary Gibbon, who retired from the office of Director of NHLBI on January 31, 2026 and acknowledged the Acting Director, Dr. David Goff.
  • Next Dr. Brown highlighted several process and policy changes that have occurred or are in process at  NIH including:
  • After this review of recent process and policy changes, Dr. Brown turned her attention to focusing on the scientific directions at NIH.
  • The new NIH director, Dr. Jayanta (Jay) Bhattacharya, is implementing a vision for optimal health for all that includes a commitment to 6 priorities. There is alignment between NHLBI priorities and NIH director priorities and his strategy to advance the NIH mission including:
    • Chronic Disease
    • Nutrition, Diet and Lifestyle
      • In addition to nutrition and physical activity the community has been pressing to include sleep as part of a triad of modifiable behaviors and any research that does not include sleep in this triad is outdated.
    • Artificial Intelligence (AI)
    • Implementation Science
    • Health Disparities Research
    • Train the Next Generation
  • The NIH-Wide Strategic Plan for FY2027-2031
    • Framework Outlines NIH’s Priorities
      • Priority 1: Research Areas
        • Address emerging and critical biomedical research areas
      • Priority 2: Research Capacity
        • Build and maintain capacity to carry out biomedical research
      • Priority 3: Research Operations
        • Operate with the highest integrity to oversee gold standard science
    •  Request for Information (RFI) for the FY2027-2031 NIH Strategic Plan – Comments until May 26
  • Dr. Brown then reaffirmed the institute’s commitment to stability and progress during this period of leadership transition by emphasizing  Enduring Principles at NHLBI:
    • Value investigator-initiated fundamental discovery science.
    • Maintain a balanced, cross-disciplinary portfolio (basic, translational, clinical, population science).
    • Train a robust, new generation of leaders in science.
    • Support implementation science that empowers patients and enables partners to improve the health of the nation.
    • Innovate an evidence-based elimination of health disparities in the U.S. and around the world.
  • Paylines no longer exist at NIH and are being replaced by NIH’s Unified Funding Policy.
  • The NHLBI funding policies and considerations outline how the institute plans to implement the Unified Funding Strategy.
  • Dr. Brown then summarized the funding levels for sleep and circadian research NIH-wide:
    • Close to $600M in total funding for FY24, FY25 numbers won’t be released until late spring or early summer.
    • Increased almost two-fold which was a direct result of internal coordination across the institutes, centers, and offices (ICOs), that opened opportunities for sleep and circadian biology.
  • She ended her report by promoting the following upcoming events:
    • Novel Alternative Methods (NAMs) in Sleep and Circadian Translational Research Workshop – Fall 2026, virtual
    • 2026 Research Conference on Sleep and the Health of Women: SHOW 2026 – October 14 – 16, 2026, Natcher Auditorium, NIH Main Campus, Bethesda, MD
  • Dr. Brown’s presentation was followed by a brief Q&A with the board.

REMARKS FROM NHLBI
David Goff, MD, PhD, Acting Director, NIH NHLBI

  • Dr. Goff began by thanking SDRAB for working with the NIH to help advance the science of sleep and circadian biology together, especially as we refresh the NIH Sleep Research Plan.
  • Chronic diseases like heart disease, lung disease, and metabolic conditions are a significant public health challenge. We have long recognized that sleep and circadian biology are critical for not only the promotion of health and the prevention of chronic diseases, but also for the management of these conditions once they occur.
  • Advancing sleep and circadian biology research is crucial for reducing the burden of chronic diseases and improving the quality of life for countless individuals around the world. NIH and NHLBI remain fully committed to that pursuit.
  • Working with the leadership of NCSDR, NHLBI  is supporting what we believe to be innovative research, technology development, robust training programs, health education initiatives, and the coordination of sleep research across NIH ICOs and other federal agencies.
  • NHLBI remains steadfast in our commitment to our mission to support rigorous high-impact research and the nurturing of the next generation of scientists who are going to continue to lead us forward towards our vision of healthy people thriving in healthy communities.
  • Dr. Goff underscored the importance of implementation science.
  • He reassured the board that the continuity of NHLBI’s commitment to the sleep and circadian biology community remains strong and unwavering.
  • The SDRAB voiced appreciation for Dr. Goff’s comments.

LEADERSHIP LENS: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR)
Jennifer Webster-Cyriaque, DDS, PhD, Acting Director, NIDCR

  • Dr. Webster-Cyriaque shared that sleep is a common topic of consideration at NIDCR, falling within 4 different areas:
    • Orofacial pain (OFP) and sleep
    • Temporomandibular disorders (TMD)
    • Obstructive Sleep Apnea (OSA)
    • Oral appliance therapy
  • OFP and sleep are interconnected because:
    • Sleep disturbance is more common in patients with chronic OFP than in the general population
    • Chronic OFP can worsen sleep disorders (insomnia and OSA)
    • Sleep disturbances may exacerbate pain and vice versa
  • A recent study showed that combining OFP treatment (e.g., self-care instructions, oral appliances, systemic medications, etc.) with psychological interventions is effective in reducing pain and sleep disturbances, and in improving quality of life.
  • Next Dr. Webster-Cyriaque discussed the second area of sleep consideration at NIDCR – TMD. She explained temporomandibular joint disorder (TMJD) is a type of TMD that is very heterogeneous and can cause:
    • Joint pain, disorders, and diseases
    • Muscle pain, contracture, and hypertrophy
    • Movement disorders
    • Disorders of associated structures
    • Neoplasms
    • Headaches
    • Central pain
  • Over the years there have been significant efforts by NIDCR to understand TMD, including the Orofacial Pain, Prospective Evaluation and Risk Assessment (OPPERA) studies:
    • OPPERA I (2006-2013)
      • Goal: discovery based prospective study to identify biopsychosocial and genetic risk factors for onset and persistence of TMJD in people with no history of the condition
    • OPPERA II (2012-2017)
      • Goal: identify risk factors that predict transition from to chronic TMJD & which factors interact to predict development of multiple chronic pain conditions
  • Another effort has been TMD IMproving PAtient-Centered Translational Research (TMD IMPACT). In partnership with multiple NIH ICOs as well as the U.S. Food and Drug Administration (FDA), NIDCR developed the TMD IMPACT collaborative with the goal of advancing basic and clinical TMD research, research training, and translation to evidence-based treatments and improved clinical care. The initiative includes three sites collectively coined:  BETTER CREATE improved outcomes for TMD patients, 360 (BC360)
  • Dr. Webster-Cyriaque reviewed the intersection of NHLBI-related research and TMD:
    • TMD-associated sleep disorders
    • Sleep-related issues like bruxism
    • Stroke
    • Mitral valve prolapse
    • Connective tissue disorders (aortopathy)
    • Pectus carinatum cardiovascular abnormalities
    • Trigeminocardiac reflex
  • She then narrowed the focus to sleep-related research and TMD:
    • TMD can be associated with poor sleep quality
    • Some patients with TMD also have sleep-related issues like bruxism
  • Dr. Webster-Cyriaque summarized the recent publication Effects of Sleep and Circadian Rest-Activity Rhythms On Daily Pain Severity In Women With Temporomandibular Disorders.
  • Next Dr. Webster-Cyriaque discussed the third area of sleep consideration at NIDCR – OSA:
    • NIDCR supports research on how facial anatomy and oral structures affect airway obstruction
    • Machine learning (ML) approaches for prediction of sleep apnea include craniofacial skeletal patterns
    • CT-based deep learning to predict OSA
  • She discussed pediatric OSA in further detail:
    • Craniofacial determinants of pediatric OSA include:
      • Anatomical factors – craniofacial structure, soft tissue abnormality
      • Non-anatomical factors – neuromotor dysfunction, hypotonia, inflammation
  • Bruxism (teeth grinding) and sleep apnea are closely linked.
    • 20-40% of pre-school aged children; up to 35% of school aged children; possibly half of teenagers, and approx. 40% of children with Down syndrome (DS) have bruxism
  • Dr. Webster-Cyriaque summarized how OSA is treated in dentistry
    • Adenotonsillectomy is the first-line therapy in the majority of pediatric OSA patients – 30-60% residual OSA
    • Continuous positive airway pressure (CPAP) therapy is a common alternative
    • Other treatments may include weight management, jaw surgery to advance jaws or chin, tongue reduction
    • Custom-made titratable mandibular advancement appliances (MAAs) are increasingly prescribed for adults with OSA
  • This led to her focus on the fourth area of sleep consideration at NIDCR – oral appliance therapy (OAT)
    • NIDCR-funded research has contributed to understanding how effective these are
    • NIDCR intramural pediatric clinical study protocol.
  • Dr. Webster-Cyriaque concluded her talk by stating she looked forward to the potential to collaborate with NCSDR in this space.
  • Following the presentation, there was a period of Q&A with the SDRAB.

U.S. Department of Veterans Affairs (VA) SLEEP RESEARCH PORTFOLIO
Amanda Hunt, PhD, Scientific Program Manager, VA

STAKEHOLDER PRESENTATION– American Thoracic Society – Sleep and Respiratory Neurology (ATS-SRN) Assembly
Neomi Shah, MD, MPH, MSc, ATSF, Professor of Medicine and Artificial Intelligence & Human Health; System Vice Chair, Department of Medicine; Senior Associate Dean, Icahn School of Medicine at Mount Sinai; Chair, ATS-SRN

  • Dr. Shah began by giving an overview of the American Thoracic Society (ATS):
    • Global Reach – a broad clinical and scientific society integrating experts worldwide.
    • Multidisciplinary Engine - uniting clinicians, researchers, educators, respiratory therapists, nurses, behavioral health specialists, and anyone working to advance sleep health under one roof.
    • Strategic Partnership – uniquely positioned to help NIH execute national sleep research priorities
    • Three pillars:
      • Pulmonary
      • Critical care
      • Sleep
  • Within ATS, the SRN functions as an integrative bridge – connecting scientific discovery to clinical and real-world impact, while building the next generation of investigators.
    • Year-round engagement – education, research, collaboration
    • Strong pipeline development – early career, trainees
    • Cross-society collaboration – e.g. American Academy of Sleep Medicine (AASM)
  • Dr. Shah proceeded to share strategic guidance from the ATS-SRN perspective on what the priorities could potentially be for sleep disorders research.
  • Must move from population-based metrics to individualized, biology-driven sleep care, advancing sleep science to precision care.
    • Sleep is a biologic necessity for human health
    • Sleep disorders are common – but poorly characterized beyond simple metrics (e.g. AHI)
    • The precision medicine challenge pertaining to guidance, tools and treatment benefits.
  • Need to rethink diagnosis – innovations beyond the sleep study.
    • Diagnosis should reflect how people actually live
    • Real-world human physiology – there is an opportunity to integrate:
      • Continuous wearable data & devices
      • Long-term behavioral patterns
      • Environmental & contextual exposures
      • Clinical data and EHR
      • Multi-omic biomarkers
    • Transition from episodic testing to real-world phenotyping to unlock continuous, longitudinal biological insights.
  • Address the missing dimensions of sleep in clinical care and EHR data.
    • Sleep is dynamic but our diagnostics remain static – a diagnostic disconnect:
      • What we measure
        • Single-night sleep study (PSG)
        • Focus on sleep apnea (AHI)
        • Static, episodic snapshots
      • What we need to measure (biology)
        • Sleep duration
        • Sleep timing (circadian patterns)
        • Sleep quality (fragmentation, continuity)
        • Continuous, dynamic physiology
    • Sleep measurements captured in EHR do not capture or integrate core dimensions of sleep, limiting both clinical decision-making and large-scale research. The impact:
      • Clinical gap
        • No tools to assess sleep duration, timing, or quality in routine care
        • Limited ability to personalize recommendations or treatment
      • Research gap
        • EHR-based studies lack key sleep variables
        • Inability to link sleep patterns to cardiometabolic outcomes at scale
    • Need to integrate sleep duration, timing, and quality into clinical workflows and EHR systems to enable precision sleep medicine.
  • Dr. Shah proposed 4 priority areas for sleep disorders treatment and research:
    • Precision Sleep Medicine
      • Goal – match therapy to patient biology
      • Outcome – risk stratification, prediction of treatment response
    • Circadian Health as a Core Domain
      • Treat timing as a fundamental biological variable
      • Circadian misalignment is a major, modifiable driver of disease
      • Measurement and phenotyping
      • Integrate circadian measurement into clinical and research infrastructure
    • Next Generation Diagnostics
      • Moving away from volume and velocity (more data) towards validity and utility (meaningful data)
      • Using AI/ML engine as an integration tool not a clinical endpoint
        • Input: physiologic, behavioral, environmental, and other patient data
        • Output: clinical decision-making, longitudinal phenotyping
      • Critical foundation:
        • Rigorous validation
        • Data standardization
        • Population equity 
    • Treatment Innovation
      • Current approach:
        • Empiric treatment escalation, broad heterogeneous trial populations, trial-and-error clinical decision-making
        • Key issue - high variability in treatment response, average effects obscure true benefit
      • Proposed approach:
        • Identify responder subgroups using real-world data
        • Define biological and clinically meaningful treatment pathways
        • Inform targeting, efficient randomized trials
        • Leverage existing data to inform who benefits, before scaling randomized controlled trials (RCTs)
        • Use real-world data (EHRs, large clinical datasets, trial emulation approaches) to simulate and prioritize treatment strategies
      • RTCs remain important but should be guided by data-driven identification of who is most likely to benefit.
  • It is time to modernize evidence generation in sleep medicine by overcoming the time-to-evidence gap.
    • Therapeutic landscape is rapidly evolving across devices, pharmacologics, and combination approaches
    • Traditional RTC timelines are prolonged (trial designs, recruitment, multi-year follow-up, analysis, publication), and could render results outdated upon completion.
    • Accelerated, adaptive evidence generation is critically needed to bridge this delay
    • Opportunity – leverage trial emulation utilizing EHR, real-world data, and continuous learning health systems
    • Goal – identify early treatment signals to accelerate their translation into clinical practice
  • It is important to align sleep research with meaningful clinical outcomes
  • Dr. Shah asserted a coordinated, cross-society approach is essential to accelerate progress in sleep and circadian health.
  • She summarized her remarks into the following key asks for NIH and SDRAB:
    • Enable next-generation diagnostics
    • Leveraging of real-world evidence platforms
    • Align research with meaningful outcomes

Dr. Shah argued these are not incremental changes, they are opportunities to modernize how we measure, study, and treat sleep and circadian disorders at a national level.

  • She ended her presentation by showing a 2-minute video that elaborated on these key asks.
  • Her presentation was followed by a robust SDRAB discussion.

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

Marishka Brown, Ph.D., Director, NCSDR

  • As there was such a rich discussion that followed Dr. Shah’s presentation, no further overview of Topic 1 was discussed.
  • Dr. Brown opened the floor to the board continuing the discussion based on the presentations they heard up to this point and the topic summaries provided prior to the meeting.

SDRAB MEMBER DISCUSSION – TOPIC 1
Moderated by Dr. Esra Tasali

  • Dr. Tasali framed the discussion around a set of foundational questions central to advancing precision medicine in sleep and circadian science.

The SDRAB discussion that followed has been organized in the following topic areas.

The Case for Methodological Investment

  • Hundreds of millions of individuals worldwide use wearable devices capable of capturing activity and heart rate-derived metrics, yet critical physiological signals remain inaccessible in real-world, continuous monitoring contexts.
  • Continuous melatonin monitoring does not yet exist as a viable wearable modality, yet it is indispensable to a rigorous characterization of circadian phase — a multidimensional construct that behavioral proxies such as movement data cannot adequately capture without complementary physiological markers, including melatonin secretion profiles and core body temperature.
  • The development of robust, validated measures across these domains is not an ancillary concern — it is a scientific imperative.
  • Unlike modalities such as electrocardiography, which can yield diagnostically actionable data within seconds, characterizing an individual's circadian phase requires sustained, multimodal data collection over days to weeks — underscoring the need for basic methods development.

Rethinking Validation Standards

  • The field has historically defaulted to PSG as the benchmark for evaluating competing measures, but this single-modality, single-night reference standard may be ill-suited to validate the continuous, longitudinal, and multimodal data streams that next-generation wearables are designed to capture.
  • Determining what constitutes a gold standard that is both scientifically rigorous and reflective of real-world conditions remains an open and consequential question.
  • For circadian biomarkers specifically, the appropriate reference standard — whether in-field cortisol sampling, serial melatonin profiling, or a combination of physiological and behavioral measures — has yet to be established.
  • Both the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs operate under the NIH Small Business Education and Entrepreneurial Development (SEED) program, with the shared purpose of translating high-risk, early-stage scientific research into commercially viable products.
  • The sleep technology sector has seen rapid growth within these programs, and the relevant industry landscape includes not only large established companies but also small businesses actively seeking to enter the field.

Regulatory Clarity and the Case for a Community-Defined Minimum Standard

  • A community-defined minimum standard, endorsed by the relevant scientific societies — including the Sleep Research Society and the American Thoracic Society — could function as a recognized seal of scientific validation, specifying concrete, measurable requirements such as a minimum PPG sampling rate of 10 Hz and raw data accessibility in a format amenable to independent analysis.
  • The field itself must take ownership of defining the relevant metrics and standards; the sleep and circadian research community is uniquely positioned to do so, drawing on input from the full range of stakeholders — patients, clinicians, and researchers.
  • The devices themselves are not the endpoint: the more fundamental questions are what we are measuring, why we are measuring it, and what minimum set of signals must be captured to answer the scientific questions the field has identified as most consequential.
  • Answering those questions in a rigorous, consensus-driven way — and embedding that consensus into overall frameworks — is the work the sleep and circadian research community is now positioned to lead. Technology will continue to advance; the more consequential question is what scientific problems the community wants that technology to solve.

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 service, noting that their guidance keeps NIH investments aligned with patient and researcher priorities. He noted that his appreciation is also personal, as his own management of sleep apnea relies entirely on nightly CPAP therapy.
  • He remarked that the previous discussion was invaluable, serving as a vital bridge between the research community and NIH to shape federal strategic priorities. This collaboration is particularly timely as NCSDR works to refresh the NIH Sleep Research Plan.
  • As acting director of DLD, Dr. Matute-Bello affirmed his unequivocal support for sleep and circadian research and noted that Dr. Goff, acting director of NHLBI, shares this deep commitment. Despite recent leadership transitions, institutional priority remains firmly fixed on advancing sleep science and executing SDRAB recommendations.
  • He shared several areas he views as central to shaping NCSDR’s future portfolios, including:
    • Ensuring the research community drives, rather than reacts to, the integration of AI/ML in sleep and circadian science
    • Advancing solutions-oriented frameworks to address health disparities in sleep and circadian disorders
    • Integrating non-biological and environmental determinants of sleep health into research design
  • Because sleep is a critical pillar of health promotion and disease prevention, Dr. Matute-Bello encouraged the board to leverage these meetings as an open forum to surface emerging priorities.
  • He emphasized that SDRAB's strategic recommendations directly shape agency priorities and drive meaningful public health outcomes.

PUBLIC COMMENTS

  • Dr. Peter Mansbach, president and founder of the Circadian Sleep Disorders Network, offered a brief comment encouraging the field to think beyond circadian phase when characterizing the circadian signal as a waveform. He suggested additional dimensions worth considering for measurement include:
    • Amplitude — the degree of contrast between alertness during the day and sleep depth at night
    • Waveform shape — for example, whether an individual rises to full alertness quickly or gradually upon waking
    • Phase flexibility — the ease or difficulty with which an individual can shift their circadian timing

CLOSING REMARKS

  • Dr. Brown remarked that the day’s discussions were very rich and informative, and she seconded Dr. Matute-Bello’s appreciation for the work of the board.
  • She affirmed that NCSDR relies on SDRAB to help shape NIH recommendations and priorities, describing the board's expertise and guidance as the driving force behind the institute's strategic direction — a dynamic she characterized as NCSDR's approach of "leading from behind."

The meeting adjourned at 5:00 PM ET

DAY 2

BOARD MEMBERS PRESENT
Dr. Josiane Broussard, Acting Chair
Mr. David Bishop
Dr. Paula Desplats

BOARD MEMBERS ABSENT
Dr. Pat McBride

AD HOC PARICIPANS
Dr. Daniel Buysse
Dr. Jeffrey Durmer
Dr. Martha Gillette
Dr. Dayna Johnson
Dr. Shaun Purcell
Dr. Alberto Ramos 
Dr. Esra Tasali
Dr. Wendy Troxel

EX OFFICIO MEMBERS PRESENT
Dr. Marishka Brown, Executive Secretary
Dr. Yejun (Janet) He
Dr. Amanda Hunt
Dr. Tracy King
Dr. Rachel Sare
Dr. Donald Shell

FEDERAL EMPLOYEES
Eight Federal employes attended the meeting in person and 15 were in attendance via Teams.

MEMBERS OF THE PUBLIC
One member of the public attended the meeting in person and 48 were in attendance via Teams (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 9:30 AM ET as announced in the Federal Notice [FR Doc. 2026-01169] on January 22, 2026.. 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 Acting Chair of SDRAB, Dr. Josiane Broussard.
  • The Acting Chair welcomed everyone and asked members to introduce themselves and provide their backgrounds, expertise, interests and activities.

RECAP OF DAY 1 / INTRO TO DAY 2

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

OFFICE OF RESEARCH INNOVATION, VALIDATION, AND APPLICATION (ORIVA)  OVERVIEW
Dana Schloesser, PhD, Program Director, NIH Office of Behavioral and Social Science Research (OBSSR)

  • Dr. Schloesser opened her remarks by sharing the following NIH announcement published in April 2025: “To integrate innovative human-based science, the NIH intends to establish the Office of Research Innovation, Validation, and Application (ORIVA) within NIH’s Office of the Director”
  • ORIVA sits in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) and its mission is to:
    • Coordinate NIH-wide efforts to develop, validate, and scale the use of non-animal approaches across the NIH biomedical research enterprise.
    • Serve as hub for interagency coordination and regulatory translation.
    • Strengthen integration with NIH-wide initiatives related to scientific innovation, alternative test methods, reproducible research, and regulatory translation.
    • Bolster NIH’s commitment to advancing scientifically valid alternatives to animal testing and needed infrastructure.
  • Expanding on current efforts, as part of ORIVA, NIH will:
    • Coordinate NIH-wide efforts to develop, validate, and scale non-animal research methods
    • Promote the development and application of 3Rs principles (replacement, refinement, reduction) for NIH-funded research
    • Serve as a hub for interagency coordination and regulatory translation
    • Expand funding, training, and infrastructure for human-based approaches
    • Enhance awareness of the value of NAMs in translational research
    • Expand NAMs infrastructure to make these methods more accessible to researchers
    • Train grant review staff to address possible bias towards animal studies and integrate NAMs experts into study sections
    • Publicly report on research spending to measure progress
  • ORIVA will have 2 divisions:
    • Division for Accelerating Innovation in Biomedical Research (DAIBR)
    • Division of National Interagency Center for the Evaluation of Alternative Test Methods (DNICEATM)
  • Dr. Schloesser explained that NIH and ORIVA view NAMs as an AI-powered data ecosystem spanning in vitro, in silico, and in chemico methodologies. This framework operates along the NAMs Confidence Continuum, moving fluidly from foundational biomedical research into toxicological validation/qualification, and ultimately, regulatory implementation.
  • She ended her overview by describing a Common Fund initiative that preceded and is closely related to ORIVA – the Complement Animal Research In Experimentation (Complement-ARIE) Program.
  • A period of Q&A followed the presentation.

NEW APPROACH METHODOLOGIES (NAMS) SCIENTIFIC PRESENTATION – 
OSA From Clinic to Bench and Back: Modeling Intermittent Hypoxia & Its Outcomes  
Anna Grosberg, PhD, Professor of Biomedical Engineering, Professor of Chemical and Biomolecular Engineering, University of California, Irvine

  • Dr. Grosberg began her presentation by giving an overview of the relationship between OSA and cardiac consequences, describing OSA as a sleep disorder characterized by repeated episodes of partial or complete upper airway obstruction during sleep. These episodes produce intermittent hypoxia (IH), which has been correlated with multiple cardiovascular consequences.
  • Dr. Grosberg described NAMs as the appropriate models for addressing these questions, specifically highlighting the benefits of in vitro organ-on-a-chip approaches:
    • These experiments can be conducted much faster than animal studies
    • They can be performed using rodent cells, allowing findings to be tied to existing in vivo rodent data
    • They can also be conducted using human induced pluripotent stem cell (iPSC)-derived cells
    • Results can be used both to deepen mechanistic understanding and to inform clinical predictions
  • However, bridging in vitro findings and clinical application requires an additional step of computational modeling
  • Dr. Grosberg provided several examples of completed and ongoing work applying this framework, noting that the underlying mathematics have been published, she focused on illustrative results rather than equations.
  • Example 1 – Computational Modeling: Translating clinical OSA data into dissolved oxygen concentrations to reveal information that AHI alone does not capture.
  • Example 2 – In Vitro NAMs: Development and application of engineered cardiac tissue platforms to complement the computational modeling work.
  • Example 3 – Computational Modeling to Improve In Vitro Simulation: Developing the mathematical tools needed to bridge patient data and the in vitro platform.
  • Dr. Grosberg closed by summarizing the broader significance of the NAMs approach, grounded in part in a recently published review examining hypoxia-based models of OSA disease severity An extensive period of Q&A followed her presentation.

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 OBSSR

  • Dr. Schloesser began by reviewing the definition of NAMS – lab or computer-based research approaches intended to more accurately model human biology, and complement, or in some cases, replace traditional research models.
  • She then reviewed the rationale for pursuing NAMs now:
    • 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.
    • Strategic Alignment: Research initiatives should align with national priorities including HHS and NIH. Cross-disciplinary partnerships among sleep and circadian scientists, AI developers, NAMs researchers, and clinicians are essential.
  • Why NAMs in Sleep and Circadian Research
    • Sleep and circadian biology has unique translational challenges:
      • Nocturnal vs diurnal species differences
      • Differences in sleep architecture
      • Differences in light responses, metabolism, and behavior
    • Many clinically relevant questions are difficult to model in animals:
      • Shift work
      • Jet lag
      • Chronic sleep restriction
      • Social/environmental light exposure
      • Aging and psychiatric comorbidity
    • Field already has a strong existing foundation in:
      • Human laboratory protocols
      • Wearable and ambulatory monitoring
      • Molecular circadian assays in human cells
      • Computational sleep/circadian models
  • Dr. Schloesser reviewed each of the existing foundations in certain types of NAMs at a high level.
  • Dr. Schloesser concluded her presentation by summarizing some opportunities for the field to leverage these NAMs technologies.
  • Short-term opportunities – data collection and harmonization of sleep and circadian-related variables, and corresponding AI model validation using existing datasets. Potential for:
    • Discovering new patterns that may predict cognitive impairments directly from sleep records and refining database analyses
  • Mid-term opportunities:
    • Tackling the problem of remote monitoring device performance and standardization for sleep and circadian research.
      • Multimodal AI models integrating behavioral, physiological, environmental, and genetic data could predict circadian misalignment and sleep disorders.
      • Device and algorithm standardization will permit reliable remote sleep monitoring and inform the development of personalized AI-driven interventions.
    • NAMs could synergize with AI/ML advances to enhance in silico models and other approaches, providing improved representations of human biology for translation.
      • This includes the development of in vitro, in silico, and organoid models to reflect human physiology and disease mechanisms for better understanding of circadian mechanisms, biomarkers, and therapeutic targets across tissues and systems.
  • Longer-term Opportunities:
    • Research could move beyond population averages to uncover individual risk profiles, with a focus on sex and/or population differences.
      • For example, AI could help address sex differences in cardiovascular outcomes related to OSA, improving the understanding of sex-specific differences in sleep disorders.
    • NAMs could play a crucial role in developing more effective strategies for prevention, diagnostics, and treatment, focusing on real-time AI-guided systems for dynamic assessment of sleep and circadian regulation.
    • Ensuring universal sleep health will require establishing global data consortia and AI ethics frameworks to ensure equitable access and safe use of AI in sleep and circadian research.

SDRAB MEMBER DISCUSSION – TOPIC 4
Moderated by Dr. Josiane Broussard

  • Dr. Broussard opened the discussion by orienting the board to the breadth of the NAMs landscape, noting that while AI and machine learning had featured prominently in the preceding presentations, the board's charge was to consider the full spectrum of NAMs and their potential applications in sleep and circadian research.
  • She invited members to reflect on cross-disciplinary opportunities, the practical and scientific challenges of transitioning away from animal models, and the standards infrastructure the field would need to build to make NAMs-based research rigorous and reproducible.

The SDRAB discussion that followed has been organized in the following topic areas.

The Case for Cross-Disciplinary Collaboration

  • Engineers and other non-traditional collaborators bring genuine excitement to oscillatory and circadian mechanisms, and the sleep research community should actively seek out cross-disciplinary partnerships.
  • While much of the NAMs conversation has centered on AI/ML, the board emphasized that NAMs encompass a much broader landscape, and grounding the sleep research plan refresh in concrete examples across that full spectrum is essential.
  • The concept of a family of digital twins, raised at a prior NIH symposium, maps naturally onto the biological NAMs landscape.

Data Standards, Wearables, and the Validation Challenge

  • For digital and wearable NAMs specifically, the "garbage in, garbage out" principle applies: community-defined data standards must precede the construction of valid AI models, and AI cannot substitute for that foundational infrastructure.
  • Common data elements (CDEs) and shared terminologies are a necessary precondition for the data harmonization the field is seeking. Ongoing efforts through the National Sleep Research Resource (NSRR) represent an important foundation, though broader buy-in across societies and research domains remains an unmet need.
  • The urgency of establishing minimum performance standards for wearable biosensors was emphasized. The science being conducted right now with inadequately characterized devices will shape the next decade of the field, and deferring standards-setting until an ideal research-grade device exists risks making any future roadmap obsolete before it is implemented.
  • Clinical utility, not just research-grade performance, should be the explicit end-point of the standards roadmap. Technology is advancing rapidly and the field cannot afford to define standards in isolation from the devices and platforms, patients and clinicians, already using.
  • The Board began by endorsing all 4 topics discussed for inclusion in the Sleep Plan Refresh. Their overall comments about each topic have been organized into the themes below.

OPEN DISCUSSION ABOUT ALL 4 PROPOSED SLEEP PLAN TOPICS
Moderated by Dr. Josiane Broussard

  • The Board began by endorsing all 4 topics discussed for inclusion in the Sleep Plan Refresh. Their overall comments about each topic have been organized into the themes below.
  • The discussion points for each topic have been organized into subtopics.

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

  • The integration of NAMs into circadian research requires particular attention: cells in culture may oscillate at different phases from one another, and synchronization methods such as serum shock are not trivial to implement. Ensuring that researchers newly entering circadian science through NAMs platforms do not need to rediscover established synchronization approaches is an important priority as the two fields converge. Equally important is ensuring that those approaches are appropriately adapted for iPSC-derived and other complex cell types.
  • Transitioning from what can be gained from organism-level models to NAMs that meaningfully incorporate a circadian dimension will take time and sustained investment. For circadian biology in particular, the field does not yet have a fully adequate NAM, and developing and validating one will require a deliberate, staged approach rather than an abrupt departure from existing models.
  • The field is at a potential inflection point: real-world technologies, longitudinal data resources, and multi-method approaches are enabling a paradigm shift from laboratory isolation protocols toward the study of circadian systems as they operate in real-world social and environmental contexts, across the lifespan.

TOPIC 2: Sleep and Circadian-Based Strategies for Prevention and Mitigation of Chronic Disease

Chronotherapy and Time as a Biological Variable

  • Chronotherapy represents a tractable near-term opportunity for clinical investigation. It encompasses the timing of food intake, physical activity, and medications to align with circadian biology. Active research is underway examining whether aligning food intake to the biological day can serve as a mitigation strategy for cardiometabolic impairments in shift workers.
  • Key health behaviors, including sleep, eating, and physical activity, are both regulated by and help to regulate the circadian clock. A compelling opportunity exists to move beyond single-behavior interventions toward integrated, circadian-informed multi-health behavior interventions that address the amount, regularity, and timing of these behaviors in concert. Appropriate treatment development work is needed before such interventions can advance to formal clinical trials.
  • The field would benefit from a mandate for time as a biological variable, analogous to the existing requirement for sex as a biological variable in NIH-funded research. A single paper or white paper is unlikely to achieve this on its own. However, a coordinated series of editorials and publications could help shift the conversation, as demonstrated by the transformative impact of the 2014 sleep health paper, which substantially changed the nature of applications NIH received in the years following its publication.
  • A critical distinction must be maintained between clock time of day and individual circadian phase when designing and interpreting chronotherapy studies. Administering a treatment in the morning or afternoon based on clock time is fundamentally different from timing it to an individual's biological rhythm, and conflating the two limits the interpretability and clinical relevance of study findings.
  • Circadian endophenotypes remain insufficiently characterized. Beyond the familiar early/late chronotype dichotomy, there may be additional phenotypic dimensions that could be clinically actionable and more meaningful to both clinicians and patients than current classifications. These include amplitude, waveform shape, and phase flexibility. Developing a more refined chronoendotype framework represents an opportunity for the field.

Measuring Circadian Phase in Real-World Settings

  • Population-level research examining timed eating and physical activity in relation to cardiometabolic health is feasible and shows promise. Home dim-light melatonin onset (DLMO) assessment has proven to be lower burden than ambulatory blood pressure monitoring in community samples. However, critiques have highlighted the cost and burden of population-scale circadian measurement, underscoring the need for better tools.
  • Better tools for estimating circadian phase in ambulatory and population settings are needed, including the equivalent of a continuous glucose monitor for melatonin or core body temperature.
  • Emerging wearable technologies measuring cortisol and melatonin through sweat are in active development and early publications are available. Temperature-based wearable monitoring holds promise as a practical circadian marker, particularly when integrated with rest-activity and heart rate signals, but current skin temperature sensors remain limited by environmental variability and do not reliably capture core temperature. Machine learning approaches combining accelerometry and temperature are being actively developed in engineering research groups and show promise for predicting circadian phase.

TOPIC 3: Sleep and Circadian Rhythms in Development, Child and Adolescent Health

Sleep and Circadian Patterns as Early Biological Signals

  • Large longitudinal data resources including the Adolescent Brain Cognitive Development (ABCD) Study, Healthy Brain and Child Development (HBCD) study, and the National Consortium on Alcohol and NeuroDevelopment in Adolescence (NCANDA) are enabling examination of sleep and circadian patterns in children and adolescents as early biological signals that predict later cognitive, mental health, and addiction outcomes, rather than treating them solely as behavioral correlates.
  • Rather than asking why adolescents develop a particular condition, the field should reframe its research questions around identifying early modifiable risk signals that set developmental trajectories in motion. These signals include sleep duration, timing, and regularity. This reframing has direct implications for prevention-oriented research design.
  • Neurocognitive vulnerability to sleep deprivation varies by chronotype and age, and resistance to that vulnerability is more predictable in certain chronotypes at younger ages. This has direct clinical utility for identifying at-risk populations before they reach the threshold of addiction or other adverse outcomes.

Environmental and Societal Influences on Adolescent Sleep

  • Rapid environmental and technological changes are profoundly affecting sleep and circadian health in children and adolescents in ways that may outpace the field's current research frameworks. These changes include the pervasive influence of social media and  AI-driven shifts in educational expectations. . Preparing young people for healthy sleep habits will require meeting them in their own language and contexts, and educating parents as a critical but underserved audience.

Intervention and Education in Pediatric and Adolescent Populations

  • Behavioral sleep interventions delivered over extended periods face significant challenges in sustaining engagement in pediatric and adolescent populations. Participants and their families often report familiarity with standard sleep hygiene recommendations but express a desire for personalized, culturally tailored guidance specific to their own routines and circumstances. Household-level interventions involving parents and children together show promise as a complementary approach.
  • Effective sleep health messaging for adolescents must be framed in terms that resonate with their priorities, rather than abstract health outcomes. These priorities include athletic performance, cognitive efficiency, and energy. Similarly, educating parents as a distinct and underserved audience requires dedicated attention and tailored communication strategies.

TOPIC 4: New Approach Methodologies in Sleep and Circadian Research

  • The board's discussion of Topic 4 during the open session affirmed and reinforced the themes developed during the dedicated Topic 4 discussion earlier in the meeting.

A PATH FORWARD: ROADMAP AND RECOMMENDATIONS

  • The board affirmed that advancing sleep and circadian science across all four topics will require a coordinated, multi-year roadmap with concrete deliverables, recurring stakeholder engagement, and mechanisms that allow standards and priorities to emerge from the research community and propagate across disciplines beyond sleep medicine alone.
  • Methodological investment must be treated as a scientific priority in its own right, not as ancillary to outcome-oriented research. This applies equally to the development of validated wearable biosensors, NAMs platforms for sleep and circadian biology, circadian phase measurement tools suitable for real-world settings, and behavioral and qualitative research methods that capture the lived experience of people.
  • Community-defined minimum standards for wearable biosensors and digital NAMs should be developed and endorsed by the relevant scientific societies: beginning with engineering specifications and sensor-level requirements before advancing to analytic frameworks and clinical integration.
  • Time as a biological variable warrants formal recognition as a research requirement in sleep and circadian science, analogous to the existing mandate for sex as a biological variable. A coordinated series of publications and society-level efforts may be more effective in achieving this than any single report or white paper.
  • Chronotherapy and circadian-informed multi-health behavior interventions represent tractable near-term opportunities for clinical investigation that cut across prevention, treatment, and implementation science. Appropriate treatment development work should precede and inform the design of formal clinical trials in this area.
  • Real-world data platforms, including wearables, EHRs, and large longitudinal cohorts, should be more systematically integrated into sleep and circadian research infrastructure. Doing so will require data harmonization, CDEs, and analytic frameworks capable of linking behavioral, physiological, environmental, and molecular data streams.
  • Patient communities across all sleep and circadian disorders, including those with rare conditions and those who currently lack validated objective outcome measures, must be engaged as active partners in shaping the research agenda. Their perspectives are essential to ensuring that the roadmap reflects both scientific rigor and real-world relevance.

PUBLIC COMMENTS

  • There were no additional comments from the public.

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

  • Dr. Brown thanked the board for their thoughtful and thorough consideration of the topics proposed for the NIH Sleep Research Plan Refresh. She noted that the plan is being refreshed to incorporate these 4 timely topics the board has been discussing.
  • After all the SDRAB input has been synthesized, the next step will be to present the Plan Refresh to the broader sleep and circadian research community.
  • One of the ways this will happen will be at the SLEEP 2026 meeting in Baltimore, Maryland. NCSDR staff and several members of the NIH Sleep Research Coordinating Committee (SRCC) will be facilitating a 2-hour discussion session on Monday, June 15 at 3:30pm to present the plan for the Refresh to attendees and solicit their feedback.
  • The goal is to publish the final Sleep Plan Refresh by the end of the year.
  • Dr. Brown ended her remarks by repeating the following announcements:
    • The NIH is accepting applications for the next director of NHLBI. The last day to apply is April 20, 2026.
    • There is an RFI open seeking input from the public on the Framework for the NIH-Wide Strategic Plan for Fiscal Years 2027–2031. The last date to respond is May 26, 2026.

The meeting adjourned at 2:00 PM ET