NEWS & EVENTS
A woman sleeping in bed.

Sleep Disorders Research Advisory Board (SDRAB) Meeting - December 7, 2023

Virtual

Description

The Sleep Disorders Research Advisory Board (SDRAB) convened virtually on Thursday, December 7, 2023. SDRAB is a Federal Advisory Committee established by the NIH Revitalization Act of 1993. The meeting opened at 10AM ET and closed at 4PM ET. Dr. Esra Tasali presided over the meeting as Chair.

Meeting Summary

BOARD MEMBERS PRESENT
Dr. Esra Tasali, Chair
Dr. Josiane Broussard
Dr. Jeffery Durmer
Dr. Erik D. Herzog
Dr. Dayna A. Johnson
Ms. Ebony Lay
Dr. Shaun M. Purcell
Dr. Alberto R. Ramos
Dr. Thomas E. Scammell
Ms. Alexandra Wharton

BOARD MEMBERS ABSENT
None

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

EX OFFICIO MEMBERS ABSENT
Dr. Monica M. Bertagnolli
Dr. Gary H. Gibbons
Dr. Joshua A. Gordon

FEDERAL EMPLOYEES: 34 Federal employees were in attendance via Zoom.

MEMBERS OF THE PUBLIC: The total number of public attendees (including researchers, clinicians, patients, and other stakeholders) watching online reported by Zoom was 33.

 

CALL TO ORDER
Dr. Marishka Brown

  • The executive secretary called the meeting to order at 10:00 AM ET as announced in the Federal Register Notice [88 FR 67324] published on September 29, 2023. The meeting was fully open to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
  • She then introduced Dr. Esra Tasali as the Chair of SDRAB.
  • The Chair welcomed everyone and asked SDRAB members to introduce themselves.

Michael Chiang, M.D., Director, National Eye Institute (NEI), NIH
Imaging, Data Science, and the Future of Research

  • Dr. Chiang began his presentation by giving an overview of what makes the eye a good model system for study:
    • Research in vision can have a broad impact on science overall
    • Quantitative, validated functional outcome measures
    • Accessibility for study:
      • Retina a part of the brain; neurodegenerative diseases (Alzheimer’s) can be detected in the eye
      • Vascular changes can be visualized and measured (diabetes)
      • It’s “immune privileged” making it a good candidate to study immunology
      • Cell-based and gene-based therapies - complex tissues are accessible and trackable
    • Artificial intelligence (AI), imaging, and omics are also easily applied to the eye – can capture images of the eye and correlate them with clinical outcome data
  • He then outlined the overlap between the eye and sleep research communities:
    • It is increasingly recognized that the eye is one of the drivers for circadian rhythms:
      • Several cell types in the retina sense light and drive non-visual circuits
      • non-visual circuits control pupillary light response, circadian photoentrainment
      • in people without vision, non-visual circuits may or may not be affected
    • Circadian rhythm, sleep, myopia
      • Sleep and day/night cycle disruptions can lead to development of myopia
      • Light exposure can effect both sleep and myopia development
  • Dr. Chiang shared the mission of NEI - to eliminate vision loss and improve quality of life through vision research by providing leadership in 4 areas to:
    • Drive innovation to prevent and treat vision diseases
    • Foster collaboration in vision research
    • Recruit, inspire, and train vision workforce
    • Educate healthcare providers, scientists, policy makers and the public
  • NEI Strategic Plan (2021-2026) is organized methodologically in ways that cut across the anatomic areas of the eye as the best way to marry the different diseases. Dr. Chiang then focused on the data science aspect of the NEI strategic plan and the unprecedented access to large scale data:
    • Biology - human genome project led to genomics, proteomics, metabolomics, transcriptomics, etc.
    • Imaging – non-invasive, raw structural and functional data
    • Clinical – electronic health records (EHRs), highly-structured exam, correlation with systemic health
    • Public health – large-scale datasets, social determinants of health
  • Data analytics able to leverage AI to analyze large datasets but several questions remain answered by AI:
    • Variety of findings in individual patients, ability to integrate image data with clinical data
    • Generalizability and bias
      • Heterogeneity of imaging devices, races, populations
      • Power of healthcare data achieved through larger, diverse, multi-site datasets
    • Unclear ground truth – doctors who look at the same data can come up with very different responses
  • To address the need for larger, AI ready datasets to avoid bias, the NIH has the Bridge2AI Common Fund Project:
    • Up to $130M over 4 years to accelerate use of AI in biomedical and behavioral research
    • Goal to generate flagship datasets about human health that can be used by scientists across multiple domains of medicine
    • 4 awards for data generation projects; 3 awards for a "Bridge Center" to integrate and evaluate of data from those projects
  • Finally, Dr. Chiang discussed the need for and potential impact of data sharing and harmonization and noted the NIH Data Management and Sharing Policy (2023) and White House Office of Science and Technology Policy (OSTP) Guidance for 2025 were designed to promote data sharing in research. What is needed is interoperability which is why there is so much interest in common data models (CDMs), which are a way to map coding data into an integrated data ecosystem and have federated analysis (standardized phenotypes, cohorts, timeframes).
    • Some of the main data models, like Informatics for Integrating Biology and the Bedside (i2b2), the National Patient-Centered Clinical Research Network (PCORnet), and the Observational Health Data Sciences and Informatics (OHDSI) have developed CDMs.
    • The CDM developed by OHDSI, Observational Medical Outcomes Partnership (OMOP), has been adopted by All of Us, the National COVID Cohort Collaborative (N3C), and the European Health Data & Evidence Network (EHDEN), and it is becoming more and more of a standard.
    • The aspiration would be for the entire research community to transform to a CDM that standardizes data and integrates into a multimodal data ecosystem.
    • Will need domain consensus about the optimal balance between the research/societal benefits of big data/data access and patient privacy, informed consent, and other ethical concerns.
    • Will also need standards for the digital imaging and other technologies that are the basis for so much AI/data science.
  • Following Dr. Chiang’s presentation there was a robust Q&A with queries from both the Board and the public.

Scientific Presentation: Sirimon Reutrakul, M.D., University of Illinois Chicago (UIC)
How Diabetic Retinopathy May Impact Sleep and Circadian Regulation

  • Dr. Reutrakul began by giving an overview of the incidence, prevalence, and public health burden of diabetic retinopathy (DR). She proceeded to describe the anatomical changes and stages of DR, followed by a review of the risk factors for the disease.
    • There is mounting evidence that DR is associated with neurodegeneration, specifically the loss of ipRGCs, which are a crucial component of the entrainment of the human circadian system to the environmental light-dark cycle. ipRGCs synchronize the secretion of melatonin, which is a pivotal neurohormone that influences sleep, circadian regulation, and glucose metabolism. ipRGC function is reduced in individuals with DR.
    • The ophthalmology team at UIC observed that individuals with DR have a decrease response to blue light stimulation of ipRGCs (post illumination pupillary response [PIPR]); the more severe the RD the lower to response to the stimulus.
  • Synthesis of melatonin is darkness dependent. One way to assess melatonin production is to look at the time of the beginning of the rise of melatonin in the blood, the dim light melatonin onset (DLMO) time. Because it is produced during the night, another way to assess the amplitude of melatonin is to measure the melatonin metabolite urine 6-sulfatoxymelatonin (aMT6s) from an overnight urine sample.
    • Lower urinary aMT6s is associated with more insulin resistance in patients with prediabetes, and lower nocturnal aMT6s has been identified as a risk factor for the development of diabetes. Clinical studies of melatonin in individuals with and without DR have shown:
      • Urinary aMT6s is significantly lower in individuals with DR
      • A1C is higher in individuals with DR (poorer glycemic control)
      • Lower nocturnal urinary aMT6s is significantly associated with higher A1C
    • Studies of association between DR, ipRGCs, sleep and circadian regulation have confirmed that A1C is higher and PIPR is significantly lower in individuals with DR. In summary:
      • ipRGC dysfunction in DR is associated with abnormal melatonin functioning, including low overnight amplitude and abnormal melatonin rhythm
      • DR is associated with irregular sleep
      • Cortisol rhythm is intact in DR, suggesting misalignment between central and peripheral clocks
      • Systemic circadian desynchrony may be common in type 2 diabetes patients with DR
  • Dr. Reutrakul concluded by highlighting the following future directions:
    • Studies to explore the potential benefits of timed administration of exogenous melatonin in DR
    • Can we use PIPR to subtype patients for melatonin administration? Patients with the smallest PIPR have the lowest melatonin and may benefit most from therapy; conversely, patients with normal PIPR/melatonin may not benefit.
    • Exploring other interventions to enhance and entrain the circadian rhythm of melatonin in DR
    • Examine other outputs of the circadian clock
    • Prioritize relevant health outcomes (sleep, glycemic control, inflammation) and examine quality of life
  • A robust discussion with the Board followed.

Scientific Presentation: Stephanie Crowley, Ph.D., Rush University
Using Bright Light and Dark to Improve Sleep & Circadian Health in Teens

  • Dr. Crowley reminding the audience that the current recommendation is for 8-10 hours of sleep per night for adolescents in high school, but most are getting around 7 hours of sleep per night; late to bed, early to rise, and ill-timed sleep. Why?
    • bioregulatory pressures – slowing of the homeostatic sleep pressure during wakefulness and a phase delay in the central circadian clock; these changes favor later bedtimes and alertness during the evening
    • psychosocial pressures – bedtime autonomy, academic demands, social networking, increased screen time; these activities can potentially feedback on bioregulatory systems to increase alertness
    • societal pressures – earlier school start times
    • going to sleep and waking up at the wrong times in circadian clock – chronic circadian misalignment is at its peak during adolescence and is associated with risks to:
  • Dr. Crowley’s research focuses on the circadian timing system during adolescence and how the adolescent circadian clock responds to light, specifically broad spectrum white light. The main outcome used is the melatonin rhythm. Previous research has shown DLMO gets later with puberty.
  • Dr. Crowley shared a recently published intervention that had the aim of shifting sleep onset earlier and extending school-night sleep duration of adolescents using morning bright light and time management plans. The bright light paired with time management plans increased school-night sleep duration, particularly in those with later phases. Future directions for this study will explore whether the benefits be sustained and how the intervention can be made more feasible and scalable.
  • A robust discussion with the Board followed.

Sleep Research and the NIH Brain Initiative - Dana Greene-Schloesser, Ph.D.

  • Dr. Greene-Schloesser began by providing an overview of the U.S. Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the mission and goal of which is to revolutionize our understanding of the human brain by accelerating the development and application of innovative technologies for understanding how neural circuits underlie complex behaviors in health and disease. The NIH BRAIN Initiative was announced by White House in 2013, as a partnership between five U.S. federal agencies & several private foundations. NIH efforts guided by two strategic plans (BRAIN 2025 and BRAIN 2.0).
  • Dr. Greene-Schloesser then shared several sleep research highlights from the BRAIN initiative:
    • Scientists used innovative neurogrid technology to show how memories ripple through the brain and that sleep boosts the communication between two regions of the brain whose connection is critical for the formation of memories
    • Research showed an AI-designed serotonin sensor may help scientists study sleep and mental health
    • A 2021 K99/R00 awardee is studying the role of astroglia calcium activity in sleep and sleep homeostasis
  • She ended her presentation by providing the link to the BRAIN Funding Opportunities page and by mentioning that sleep is mentioned in several of the BRAIN requests for applications (RFAs). Dr. Greene-Schloesser shared there is a program in the BRAIN initiative called the Brain Behavior Quantification and Synchronization Program that is focused on understanding the neural basis of behavior, and sleep and light exposure would fall under that program. Finally, there is a NIH Common Fund program that focuses more on the periphery called Stimulating Peripheral Activity to Relieve Conditions (SPARC).
  • A robust discussion with the Board followed.

NIH-wide Programmatic Updates – National Collaborative on Childhood Obesity Research (NCCOR) - Marissa Shams-White, PhD, MSTOM, MS, MPH, Program Director, National Cancer Institute (NCI)

  • Dr. Shams-White began by giving some background on NCCOR, which was launched in 2009 as a public-private partnership between 4 leading research funders: the NIH, Centers for Disease Control and Prevention (CDC), U.S. Department of Agriculture (USDA), and the Robert Wood Johnson Foundation. Its mission is to accelerate progress in reducing childhood obesity for all children in the U.S., with attention to high-risk populations and communities. The organization focuses on efforts with potential benefit to children, teens, their families, and the communities in which they live. NCCOR has 5 overarching goals:
    • Identify, design, and evaluate interventions
    • Increase and improve surveillance
    • Improve capacity to conduct research and program evaluation
    • Provide national leadership to accelerate implementation through communication and outreach
    • Work with non-health partners to integrate childhood obesity priorities
  • She then gave a brief overview of the contents of the NCCOR website, which includes access to 7 robust research tools, one of which she focused on during the rest of her presentation, the Catalog of Surveillance Systems (CSS) Provides access to 114 publicly available U.S. datasets relevant to childhood obesity research at the individual, home/family, community/organization, or macro level(s). CSS allows users to search and filter datasets by level and scope, key variables, age groups, racial and ethnic groups, design, and cost. The key variables list historically included variables related to diet, physical activity, weight, and geocode/linkage.
  • Importantly, CSS was recently updated to add sleep-related variables to the list because:
    • Short sleep duration and poor sleep quality may be associated with an increased risk of childhood obesity
    • Evidence gaps exist that require additional research
    • Multiple behaviors that occur over the 24-hour circadian cycle are important determinants of childhood obesity, such as diet, physical exercise, sleep
    • Diet, physical activity, and sleep are important modifiable risk factors of interest and it’s important to consider the complex interaction between them and how they may together impact the risk for obesity
    • NCCOR recognized the need to support researchers and public health practitioners to advance progress on the study of sleep and childhood obesity
  • The NCCOR working group, with guidance from a sleep expert panel, developed categories for the sleep data that capture the sleep environments, sleep duration and quantity, sleep disorders, and more.
  • Dr. Shams-White shared that of the 114 datasets in CSS, 36 include sleep-related data and over 2 dozen also include diet and physical activity data, capturing all 3 variables. The key variables are generally categorized so users will need to visit the specific study site to learn more about the data and variables. However, CSS allows users to quickly and easily identify and compare datasets that could have the data they are looking for.
  • Now that the CSS has been updated, NCCOR is focusing on promoting the tool to the sleep research community and they welcome input on groups and organizations that should be targeted in their partner outreach.

Federal Stakeholder Updates - Patient-Centered Outcomes Research Institute (PCORI)
Alyssa Krumlauf, PhD, Associate Director, Clinical Effectiveness and Decision Science
Improving Patient-Centered Outcomes in Sleep Health

  • Dr. Krumlauf began by giving an overview of PCORI. It is an independent nonprofit research organization authorized by Congress in 2010 and reauthorized for another 10 years in 2019, that seeks to empower patients and others with actionable information about their health and healthcare choices. PCORI is the leading funder of patient-center comparative clinical effectiveness research (CER). They also fund awards designed to promote engagement in research, research dissemination and implementation, methodology, and the development of research infrastructure.
  • Their Strategic Plan, developed in 2022, outlines 5 synergistic national priorities that revolve around patient-centered health and that are reinforced by the cross-cutting themes of health equity and stakeholder engagement:
    • Increase evidence for existing interventions and emerging innovations in health
    • Enhance infrastructure to accelerate patient-centered outcomes research
    • Advance science of dissemination, implementation, and health communication
    • Achieve health equity
    • Accelerate progress toward and integrated learning health system
  • PCORI’s current sleep health portfolio includes:
    • 7 CER awards for Obstructive sleep apnea (OSA), Insomnia, and General sleep health
    • Methods projects for Incorporating symptoms measures into primary care practice, and Development of pediatric sleep health items banks
    • 5 Engagement, Dissemination & Implementation awards
  • Dr. Krumlauf then reviewed the upcoming PCORI funding opportunities that are issued 3 times annually and invite investigator initiated research. PCORI had a funding announcements in sleep health in both 2023 and 2024. Special areas of interest included:
    • Promoting sleep health equity
    • Chronic conditions co-occurring with sleep disturbances
    • Focus on sleep health beyond diagnosed sleep disorders
    • Promoting sleep health in inpatient settings
  • Dr. Krumlauf ended her presentation by sharing the following PCORI resources available to the public:
    • Engagement Tool and Resource Repository is a searchable peer-to-peer repository with 400+ engagement-related tools and resources developed and used by PCORI awardees that includes toolkits, case studies, engagement guides, training manuals, white papers, tip sheets, and more
    • PCORnet is a national-scale network containing high-quality health data from established patient partnerships utilizing deep research expertise
  • A robust discussion with the Board followed.

NIH-wide Sleep Research Coordinating Committee (SRCC) Presentation
National Institute of Neurological Disorders and Stroke (NINDS)

Janet He, PhD, Program Director, Division of Neuroscience
Overview of NINDS Sleep Research Funding

  • Dr. He began by pointing out that neuroscience research is growing, both in terms of funding and scientific advances. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to improve neurological health for all people:
    • Supports and performs basic, translational, and clinical neuroscience research
    • Funds and conducts research training and career development programs
    • Promotes the timely dissemination of scientific discoveries and their implications for neurological health
  • Next she discussed the NINDS Strategic Plan and Initiatives. Dr. He shared that in alignment with that mission, NINDS funds sleep and circadian research. Sleep disturbances often exist in neurological disorders and can affect disease progression and interfere with treatment.
  • NINDS is also committed to reducing the disproportionate impact of neurological disease borne by underserved groups of society by funding a spectrum of research from basic science through clinical studies, and training the next generation of health disparities Investigators:
  • Dr. He noted the NINDS efforts to address myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a serious, chronic, complex, and systemic disease associated with neurological, immunological, autonomic, and energy metabolism dysfunction. In the Fall of 2022 NINDS launched a strategic planning process to develop a Research Roadmap to identify target for the development of treatments and how best to advance ME/CFS research.
  • NINDS is also leveraging several other NIH-wide initiatives related to sleep research, including:
    • BRAIN
    • HEAL – Helping to End Addition Long-term (launched in 2018)
    • AD/ADRD – Alzheimer’s Disease and Alzheimer’s Disease Related Dementias
    • RECOVER – REsearching COVid to Enhance Recovery
  • She ended by highlighting the Annual NINDS Non-Profit Forum (July 23-24, 2024) – goal to increase patient engagement in all appropriate aspects of NINDS research to better address priorities of patents and their families and to improve the efficiency and effectiveness of research.
  • A robust discussion with the Board followed.

Brooks Gross, PhD, Program Director, Division of Translational Research
An Exploration of Translational Funding Opportunities at NINDS

  • Dr. Gross began by pointing out there are many programs across NINDS’s Division of Translational Research and Division of Clinical Research that aim to translate basic neuroscience discoveries from bench to bedside:
    • Screening programs
    • Therapeutic and diagnostic development, verification, and validation
    • All phases of human clinical trials
    • Many of these programs have parallel opportunities for small business
  • He then focused his talk on NINDS efforts to support the translational neural devices, highlighting those related to sleep. The goal of the translational devices team is to support the development, optimization, and translation of diagnostic and therapeutic devices for disorders that affect the nervous or neuromuscular systems. Translational activities can begin with device finalization and preclinical testing for regulatory approval to carry out first-in-human clinical trials, or if regulatory approval is imminent, they can go directly into the clinical trial.
  • Under the BRAIN initiative – Neural Recording and Modulation Program supports novel methods to record and modulate signal of the central nervous system (CNS) at cellular or circuit resolution that can then be used as foundations for neurotherapeutic strategies for any human CNS disease or disorder that fits within the BRAIN initiative
  • Under the HEAL initiative – grant programs that support translation of diagnostic and therapeutic devices for the treatment of pain.
  • Under the NIH Blueprint for Neuroscience Research – MedTech NIH incubator accelerates the development of cutting edge medical devices to diagnose and/or treat disorders of the nervous system
  • Sleep has many functions. It is intertwined with health and disease, and often characterized as a feedback loop pushing the system away from a healthy equilibrium. Several clinical grade neuromodulation devices have the ability to record signals which now allows therapies to move beyond the constant delivery of stimulation pulses in an open loop toward the development of closed-loop strategies based on biomarkers to improve clinical outcomes and understand the dynamics of brain function. Dr. Gross highlighted the following examples:
  • He ended his presentation by promoting the NIH-funded NeuroTech Course which provides both online educational resources and annual workshops on translating and commercializing neurotechnology.
  • A robust discussion with the Board followed.

NINDS and the Exposome: David Jett, Ph.D., Director, Office of The Neural Exposome and Toxicology (ONETOX )

  • Dr. Jett began by stating genetics has been invaluable in terms of providing insight into the etiologies of inherited diseases, however, most health risk factors cannot be explained by genetics alone. He defined the exposome as all the environmental exposures affecting the genome, all the non-inheritable factors that affect gene expression across the lifespan. The exposome has three main areas:
    • Endogenous factors (Genetics/epigenetics, Pre-existing conditions, Metabolism, Microbiome, Xenobiotics)
    • Exogenous factors (Environmental toxicants, Light and noise, Climate, Ecosystems, Economics/education)
    • Behavioral factors (Psychosocial effects, Drugs/alcohol/tobacco, Lifestyle, Sleep, Stress)
  • A true exposomic study considers all three areas. The exposome represents a new frontier of biomedical research to complement the genome and unlock a more holistic approach to disease prevention and more effective and personalized interventions. The timing for these studies is ripe because of the opportunities for data, tools (e.g. CTD, HHEAR) and team science now available.
  • Many neurological disorders have complex etiologies that include non-inheritable factors, collectively called the neural exposome. The goal of the NINDS Office of the Neural Exposome and Toxicology (ONETOX) is to advance our understanding of the multiple causes of neurological illness and to enable the development of more effective interventions.
  • Dr. Jett noted the prevention, diagnosis, and treatment of several neurological diseases and conditions are now being studied through and exposomic lens and NINDS Council is in the process of drafting a Neural Exposome Strategic Plan
  • Dr. Jett ended his presentation by sharing there are several Neural Exposome Funding Opportunities and Neural Exposome Notices and Other Funding Announcements currently available.
  • A robust discussion with the Board followed.

Director’s Report From The National Center On Sleep Disorders Research (NCSDR), Marishka Brown, Ph.D.

  • Dr. Brown focused her report on the refresh of the 2016 NHLBI Strategic Vision that is currently underway and which is complementary to the NIH-Wide Strategic Plan and the 2021 NIH Sleep Research Plan. The NHLBI Strategic Vision is being refreshed to address emerging scientific opportunities, guide future heart, lung, and blood diseases and sleep disorders and health research, and align with NIH strategic planning. The refresh will focus on 6 specific areas:
    • Harnessing data science and new technologies to drive scientific discovery and precision health
    • Using novel approaches for addressing health disparities and tackling their biological underpinnings for heart, lung, blood diseases, and sleep disorders
    • Furthering the science on the importance of lifestyle behaviors
    • Leveraging the power of community and patient engagement
    • Supporting women’s health through the lifespan
    • Addressing and reducing the impact of “place” (geography, climate, urban/rural, neighborhood) on heart, lung, blood, and sleep health.
  • She indicated NHBLI wants to hear from community about the refresh. A request for information was issued (that closed on December 15, 2023) and she gave the url for the webpage where more information and progress updates can be viewed.
  • Dr. Brown also highlighted upcoming 2024 sleep and/or circadian workshops and encouraged the community to sign up for the SleepRFA listserv to receive reminders about these and other events:
    • Sleep in Cardiovascular Resilience: Mechanisms, Implications, and Applications – April 24 & 26, 2024
    • Big Data Approaches for Novel Mechanistic Insights on Disorders of Sleep and Circadian Rhythms - May 2-3, 2024
    • Sleep-Disordered Breathing Heterogeneity and Personalized Approaches to Diagnosis, Treatment and Implementation – September 12-13, 2024
    • HEAL Workshop: Sleep, Pain, and Opioid Use Disorder (Date TBD, Fall 2024)
  • Finally, the Director noted NHLBI is still having some challenges with the community understanding what applications are appropriate for the parent R01 clinical trial required mechanism. There are limitations on those applications.
    • NHLBI will accept applications in response to the NIH Parent (R01 Clinical Trial Required) notice of funding opportunity (NOFO) that propose:
      • Mechanistic studies that meet NIH’s definition of a clinical trial and that have the primary goal of understanding how an intervention works
      • Fundamental or basic experimental studies involving humans (BESH) that do not have specific processes or products in mind
      • “hybrid” applications, i.e., applications that propose non-interventional fundamental science aims along with the mechanistic or BESH clinical trial(s)
      • Studies using surrogate or clinical outcomes for the purpose of providing preliminary proof of an expected effect
    • The following types of clinical trials are not allowed and will not be accepted by NHLBI under the Parent R01 Clinical Trial Required NOFO:
      • Early phase clinical trials for therapeutics and/or diagnostics
      • Studies to develop or conduct tests of the clinical efficacy/effectiveness of treatments
      • Studies that have safety, clinical efficacy, clinical management, and/or implementation goals
      • These types of studies would need to go through either the single site R61, R33 mechanisms, or the multisite UH3, UG3, and U24 mechanisms which have applications for both clinical coordinating centers as well as data coordinating centers
      • Also, as was shared earlier, PCORI accepts CER applications
    • When in doubt, contact a program official (PO) to discuss your application! The NIH Sleep Research Coordinating Committee (SRCC) webpage lists all the POs for sleep NIH-wide

Public Comments

  • There were no requests from the public to comment. But the public was encouraged to feel free to send future questions they have to ncsdr@nih.gov with any questions they may have about today’s meeting.

Advisory Board Discussion

  • SDRAB discussed sex as a biological variable (SBV) and what NIH is doing to encourage this inclusion in research.
    • There are many complexities to including SBV that must be considered, including the need to control for the estrogen cycle depending on what the research question is
    • The board also expressed a desire to see more discussion around the issue of sleep and circadian rhythms in maternal/fetal interactions
  • Concerning the 2021 Sleep Plan, SDRAB noted the importance of having some metrics that could be used to measure the success of the plan or inform the need and ways in which to update it.
  • The Board also discussed the need to start considering age as a biological variable in sleep research in much the same way we recognize the need to consider SBV. There has been almost no work to consider how some of the sleep interventions we have discussed today, among others, work in people who are older.
    • The Board also noted the need to look at these variables when defining normative sleep
  • To move towards advancement of sleep equity, SDRAB noted the importance of not just focusing on the individual level, but also using more of a socioecological lens, considering the intersectionality of identity and environment and how that affects sleep and can make individuals more vulnerable to the adverse consequences of poor sleep health.