The Sleep Disorders Research Advisory Board (SDRAB) convened virtually on Thursday, December 1, 2022. SDRAB is a Federal Advisory Committee established by the NIH Revitalization Act of 1993. The meeting opened at 12PM ET and closed at 5PM ET. Dr. Gabriel Haddad presided as Chair.
BOARD MEMBERS PRESENT
Dr. Gabriel Haddad, Chair
Dr. Si Baker-Goodwin
Dr. Erik Herzog
Ms. Ebony Lay
Dr. Alberto Ramos
Dr. Tom Scammell
Dr. Esra Tasali
Ms. Alexandra Wharton
BOARD MEMBERS ABSENT
Dr. Jeffery Durmer
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
FEDERAL EMPLOYEES: 43 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 31.
CALL TO ORDER
Dr. Marishka Brown
- The executive secretary called the meeting to order at 12:00 PM ET as announced in the federal register [FR Doc. 2022-23689], published on November 1, 2022; Amended Notice of Meeting [FR Doc. 2022-24203], November 7, 2022. The meeting was fully open to the public according to provisions of US code and Federal Advisory Committee Act as amended. Board members were reminded that 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.
Dina Paltoo, Ph.D., MPH, Assistant Director, Scientific Strategy and Innovation, National Heart, Lung, and Blood Institute (NHLBI)
- Dr. Paltoo thanked members for their attendance and continued engagement on the board. She explained that NHLBI continues to be heavily engaged and supportive of sleep and circadian research including by way of engagement across the NIH and nationally. She expressed that various data are being used to study the roles of sleep in cardiovascular and other diseases as well as treatments, and have served as a source for the American Heart Association adding sleep in its new Essential 8 for cardiovascular health.
- Research studies describing meal timing, food intake and sleep onset timing, and other examples at the intersection of sleep, nutrition, meal intake, and health were presented. Dr. Paltoo encouraged those in the community to continue to use the important venue of SDRAB to share information and discuss ideas and opportunities. She then thanked the NCSDR director for her leadership.
- Dr. Brown thanked Dr. Paltoo for the exceptional support of NHLBI for sleep and circadian research and various related activities and actions. She then introduced Dr. Julie Obbagy and Dr. TusaRebecca Pannucci from the United States Department of Agriculture (USDA).
FEDERAL STAKEHOLDER UPDATE
United States Department of Agriculture (USDA) Dr. Julie E. Obbagy, Ph.D., R.D., Branch Chief-Nutrition Evidence Systematic Review, Center for Nutrition Policy and Promotion, Food and Nutrition Service, and Dr. TusaRebecca Pannucci, Ph.D., MPH, R.D., Branch Chief-Nutrition and Economic Analysis Branch, Food and Nutrition Services, Center for Nutrition Policy and Promotion
- Drs. Obbagy and Pannucci provided an overview of the process for developing dietary guidelines for Americans. They described the history and purpose of the dietary guidelines as well as the updates that occur every 5 years. The dietary guidelines have always been evidence-based and as nutrition science has evolved there is a greater recognition of the role diet plays in disease prevention and health promotion. For the 1985 iteration, an external federal advisory committee was convened to assist with guideline development and this process continues to this day.
- The guidelines provide the what and how much of foods to consume to meet health needs—related areas not specific to the guidelines include clinical guidelines, etc.
- Described details of the current 2020-2025 guidelines (e.g. limiting foods higher in added sugar, saturated fat and sodium; limiting alcoholic beverages; and other important recommendations.
- Information about the process for continued development of the guidelines was provided, including the advisory committee timeline for its various meetings and ongoing public comment period. Details of the process include:
- identifying the scientific questions,
- appointing the advisory committee,
- advisory committee review of the scientific evidence (the 6 public meetings are held during this stage).
- scientific approaches to consider the evidence were described and include nutrition evidence systematic review (uses systemic, rigorous, and protocol-driven methods), data analysis (collection of analyses that use national data sets), and food pattern modeling (analyses to study and show how changes in food and beverages in dietary pattern influence meeting nutrient needs across life stages),
- developing the 2025-2030 dietary guidelines for Americans with a federal writing team from the HHS & USDA with input from federal agencies and the public—a peer review process is also integrated with a rigorous approval and clearance process,
- implementing the 2025-2030 dietary guidelines for Americans—federal nutrition programs are important users of the guidelines, however entities outside of the government use these guidelines as well (healthcare professionals, the American public, etc.)
- An update on the current status of the overall process was given. Evidence review is ongoing, covering scientific topics, health outcomes, approaches, and health equity. Frequency and timing of eating are topics of interest and the following was proposed to the board for discussion: what is the relationship between timing of eating occasions and:
- growth, size, body composition, risk of overweight and obesity, and weight loss and maintenance,
- consuming a dietary pattern that is more aligned with the Dietary Guidelines for Americans).
- SDRAB discussed the following specific topics with the presenters:
- changes across the age spectrum,
- genetic predispositions,
- potential flexibility to integrate scientific knowledge that may arise urgently in between the usual 5-year review timeline,
- communicating with the sleep and circadian research field,
- having the scientific community organized and actively engaged and integrated in the development process,
- importance of public comment stages,
- various outcomes of glucose control,
- whether some types of evidence receive different weight and importance (evidence conducted in humans receive more attention),
- alignment of dietary guidelines with obesity reduction goals,
- taking into account novel ways of adherence to calorie-restricting diets (e.g. sleep duration and calorie intake, and related interventions),
- the joint development of the guidelines between USDA and HHS,
- macronutrients (e.g. carbohydrates and relationship to neurological health),
- works of other entities that feed into the process.
Eliseo J. Pérez-Stable, M.D.
Director, National Institute on Minority Health and Health Disparities (NIMHD)
- Described the various populations experiencing health disparities, including racial/ethnic minorities, those with less privileged socio-economic status, underserved rural populations, and sexual and gender minorities.
- Expressed race/ethnicity and socioeconomic status are fundamental in determining health and should be consistently measured in standardized ways. Multiple examples of diseases disproportionately affect minorities were offered.
- Provided examples of what science can do to reduce inequities (e.g. common data elements, big data, diversity of the scientific and clinical workforce, community engagement and building trust for sustainable relationships, and implementing effective strategies).
- Described components of social determinants of health measures (e.g. demographics including family background, geography, cultural identity, language proficiency, structural determinants, standard data elements).
- Demonstrated the research framework developed by NIMHD to explain the various components of data, research, and levels of influence (domains of influence vs. levels of influence).
- Historical data pertaining to the perception of unfair treatment were shared and their importance was discussed.
- Described racism as a research construct, including its multiple domains and components. Dozens of R01 awards are currently being supported that relate to this issue with plans to continue supporting this area in the future.
- Details about historical redlining policies and how they influence social segregation and the trajectory of health outcomes were shared, including how the effects on health may be addressed (an area of focus for NIMHD).
- Provided examples of community-driven health equity structural intervention research. The combined effort with NHLBI to develop and stand up the NIH Community Engagement Alliance (CEAL) against COVID-19 disparities was described, with its various components and plans to transition to more than COVID.
- Highlighted community-engaged research to reduce health disparities, describing the components and what is needed to ensure these efforts succeed at all levels with all persons involved.
- Presented data from sleep-related research at NIMHD.
- Information was shared about the 2018 Sleep Health Disparities workshop and report, a joint effort of the NIMHD, NHLBI, and Office of Behavioral and Social Sciences Research (OBSSR). At least two dozen grants have been awarded in response to the resulting program announcement.
- The goals and interests of the research program were outlined (e.g. looking at the population perspective and relevance of measured sleep as a protective or other relevant factor), and findings from the program were shared (e.g. clinical, behavioral, and community factors associated with sleep duration and efficiency among black smokers, links between structural racism and sleep.)
- Specific research areas to be addressed were highlighted regarding sleep and minority health and health disparities:
- sleep quality and quantity and how they may relate to demographic and social determinants,
- contribution of sleep quality and quantity to development of chronic disease (obesity, cardiovascular disease, chronic inflammation, etc.),
- measurement of sleep as a protective factor from chronic disease (e.g. a new way of thinking about physical activity),
- management of insomnia in clinical settings,
- sleep disorders in particular obstructive sleep apnea (OSA), etc.
- SDRAB expressed gratitude for the overarching topic and members discussed the following with the director:
- studying sleep timing and efficiency (e.g. biological assay measured, genetics, environmental factors, etc.),
- sex and gender differences in sleep efficiency,
- the context and details of Hispanic and Latinx research,
- studying sleep deficiency in minoritized populations, its relationship with comorbidities and disease, and the need to further explore phenotyping, effects of ambient noise and lighting, and other macro factors,
- possible recommendations for enhancing and maintaining the pathway of relevant researchers in this domain across all types of science – every investigator should see this as a responsibility of the profession
- importance of future sleep and minority health research, including interventions.
- Dr. Pérez-Stable reassured the community that sleep and minority health will continue to be a long-term priority for the Institute, with or without specific program announcements.
- Dr. Brown noted the importance and success of the program announcement that had been issued by NIMHD in collaboration with NHLBI and several other Institutes, Centers, and Offices (ICs) at NIH.
UPDATES FROM STAKEHOLDER GROUPS
Society for Research on Biological Rhythms (SRBR)
John Hogenesch, Ph.D., Professor, University of Cincinnati Department of Pediatrics/Cincinnati Children’s Hospital
- Described the mission and activities of SRBR which include:
- a biennial conference and journal,
- research on biological rhythms, circadian medicine, and other areas, with a current emphasis on translation into the clinic,
- educational and training activities with a focus on the developing world, including Latin America,
- advocacy and outreach, including a website and social media, white papers on various topics, outreach fellowships, and public advocacy in coordination with the Sleep Research Society
- Highlighted SRBR’s commitment to diversity, as demonstrated by fellowships to underrepresented minorities and trainees from low-income countries (Emmett Chappelle awards), mentor-mentee pairing for an entire year, diversity in all SRBR committees, and input about training from Morehouse School of Medicine.
- Described priorities including those set in response to the NIH Sleep Research Plan, efforts to move circadian biology to the clinic, and studies on feedback loops between daily rhythms and behavior.
- Identified current challenges to be addressed.
- SDRAB members discussed the following with Dr. Hogenesch: the timing of food intake in relation to circadian rhythm to achieve the most efficient metabolism, and research and public implementation activities in this area including similarities and differences across the lifespan (pediatric vs. adult in timing of meals).
- Research about food in relation to circadian phase or timing of sleep were highlighted as important issues needing further exploration.
American Academy of Sleep Medicine (AASM) Foundation
Anita V. Shelgikar, M.D., MHPE, Director, Sleep Medicine Fellowship/Clinical Professor, Neurology, University of Michigan
- Presented the mission, vision, core values, and goals of the AASM. Activities for each goal include public awareness, technology innovation, workforce development, and advocacy.
- Described recent and upcoming publications that include clinical practice guidelines, two position statements, and updates.
- Promoted the following upcoming events: Sleep Medicine Trends, about improving care for patients with chronic insomnia disorders, February 17-19, 2023, and SLEEP 2023 meeting, June 3-7, 2023.
- Shared the mission and structure of the AASM Foundation.
- In 2022 the Foundation awarded over $2.4 million to support 37 grants/awards, 28 early career investigators, and 4 scholarships for medical students interested in sleep research.
- Collaborations with various stakeholders were described and include Hypersomnia Foundation, Wake Up Narcolepsy, Sleep Research Society (SRS) small research grant, and Chest Foundation research grants in sleep medicine.
- Promoted the upcoming 2023 Annual Young Investigators Research Forum, April 26-28, 2023 in Bethesda, MD, the Sleep Research Career Pathways webinar series, and currently open grants opportunities.
NIH-wide Programmatic Updates
Christopher J. Lynch, Ph.D., Acting Director, Office of Nutrition Research (ONR) Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) NIH Office of the Director
- Dr. Lynch outlined the history, background, mission, and key responsibilities of ONR.
- Described the NIH-wide Nutrition Research strategic plan, including cross-cutting research areas, indicating where chrononutrition, circadian rhythms, life span (including pregnancy), clinical nutrition, and data science and research fit in.
- Co-funding and supplement funding were highlighted and include work with nutrition during pregnancy, dietary biomarkers, nutrition for precision health, and physiology of the weight reduced stage clinical trial consortium with some sleep measures.
- The Nutrition for Precision Health program was described in detail and includes use of comprehensive sets of data in large and diverse populations.
- Recent and future initiatives and research planning by ONR were outlined and include chrononutrition and substantial research support of various ICs including NIA, NCI, NHLBI, and NIDDK.
- Examples of the alignment of chrononutrition with several ONR strategic goals were described, including clinical studies led by NIA: caloric restriction and time-restricted feeding. There is broad NIH interest in chrononutrition.
- Dr. Lynch discussed potential opportunities for lower cost and feasible additions of sleep measures to current studies.
- Limits of animal/lab-based research versus human real-world settings for time-restricted feeding/eating studies were described, and the need to consider definitive human studies (e.g. larger studies) was identified as a gap.
- The public can find current information about time-restricted eating primarily from the relevant professional societies and Dietary Guidelines for Americans.
NIH-wide Sleep Research Coordinating Committee (SRCC) Presentation
Corinne M. Silva, Ph.D., Program Director, Division of Diabetes, Endocrinology, & Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Provided a history of NIDDK’s involvement in sleep and circadian rhythms and coordination with NCSDR.
- NIDDK’s sleep and circadian research portfolio spreads across all scientific program divisions and the number of awards in this area has steadily increased since 2013 with about 2% of the Institute’s budget going to this research. The majority of awards are basic research grants, but 22% are human research including 17 clinical trials.
- Relationships between circadian rhythms and metabolic disease were described in detail, and information was provided about peripheral clocks in metabolic tissues. Examples of active research grants in these areas were provided.
- NIDDK has held workshops related to the impact of sleep and circadian rhythms on metabolic processes that have led to funding opportunity announcements and funded grants in exploring chronic sleep restriction, sleep stabilization, OSA, sleep extension, and other related topics.
- An informative research article about time-restricted feeding and several current grants covering this area were shared.
- Lastly, NIDDK is sponsoring a symposium in 2023 about circadian rhythms at the intersection of energy balance and metabolism: 2023 ENDO NIDDK early investigator symposium.
- SDRAB members discussed the intersection and state of the science pertaining to circadian rhythm/nutrition and metabolism in humans with Dr. Silva as well as the exciting work in the area of restricted feeding/eating across various endpoints. The usefulness of existing animal studies and the importance of moving to human studies, including research in precision medicine, was noted.
Scientific Focus Presentation
Frank A.J.L. Scheer, M.Sc., Ph.D., Professor of Medicine, Harvard Medical School Director, Medical Chronobiology Program Brigham & Women’s Hospital
- Covered the role of daily rhythms in disease severity, disease risk, and meal timing as countermeasure against adverse effects of circadian misalignment, and how meal timing matters for body weight and glucose regulation.
- An overview was provided of the circadian system and central and peripheral clocks, what happens when the inputs (light, food) are not aligned, and role of circadian system in daily rhythms disease severity across night and day.
- Shift work is another area of concern with approximately 14 million Americans working at night, and epidemiological evidence of health risks and the need to understand circadian misalignment effects were presented.
- Although the question remains of whether these adverse effects are explained by mistiming of sleep or by mistiming of food, current research appears to indicate the effects of shift work and circadian misalignment may be addressed by meal timing (e.g. eating during the day).
- Meal timing also appears to affect energy balance and research shows late circadian meal timing leads to higher BMI and adiposity. When controlled for the circadian clock, this association falls apart, further highlighting the role of food timing. This information has resulted in multiple hypotheses for further research.
- Other research shows late eating increases day-time hunger, and waketime and 24-hr ghrelin/leptin ratio. Late eating also decreases waketime energy expenditure and core body temperature across 24-hr, and alters adipose tissue. In addition, studies indicate late dinner timing impairs glucose tolerance.
- In summary meal timing may be a promising counter measure for circadian misalignment effects, with not just what but when you eat being of critical importance.
- Additional areas of focus and future research directions were described.
- SDRAB discussed cultural norms and other factors that impact susceptibility and resilience in populations pertaining to obesity.
- Whether energy expenditure translates to being less or more energetic was deliberated. Considerations include the difference between measuring energy expenditure biologically versus properly measuring the energy level of a person and how they feel (e.g. less or more energetic, cognitive performance and attention, mood, etc.).
DIRECTOR’S REPORT FROM THE NATIONAL CENTER ON SLEEP DISORDERS RESEARCH (NCSDR)
Dr. Marishka Brown
- Summarized the vision for NCSDR: ensure that sleep, alongside physical activity and nutrition is a pillar of optimal health and wellbeing.
- Described activities surrounding the implementation of the recent NIH Sleep Research Plan with bold predictions for future sleep and circadian research. Relevant objectives for sleep and circadian research and strategic plans for NIH nutrition research were highlighted along with other government plans including the Biden-Harris Administration National Strategy on Hunger, Nutrition, and Health.
- Select funding opportunity announcements at NHLBI were presented and NHLBI requirements and limitations for submitting clinical trial applications were described. The research community continues to be strongly encouraged to contact relevant Program Officials before submitting applications to NIH.
- Demonstrated data showing the number of grants funded in sleep and circadian science by the various NIH ICs, noting more than half a billion dollars in support across the NIH in fiscal year 2022.
- Lastly, the new NIH Data Management and Sharing policy was highlighted. The National Sleep Research Resource (NSRR) held a webinar about how it can help sleep and circadian researchers meet their data sharing policy obligations. These videos are posted on YouTube.
- For future 2023 SDRAB meetings the directors of NHLBI and NIBIB have been invited and will hold discussions with the group.
- Two staffing updates were provided: Dr. Gustavo Matute-Bello has joined the Division of Lung Diseases (DLD) as deputy director and will attend future SDRAB meeting; Dr. Koyeli Banerjee will leave DLD and join AHRQ at the end of 2022.
SDRAB Member Discussion
- SDRAB discussed ongoing and potential future activities surrounding the integration of sleep with nutrition (diet) and physical activity for health.
- Considered how SDRAB could further expand its messaging and ambassadorship for sleep and circadian health—each member has the responsibility to represent sleep and circadian biology to various audiences across the nation.
- The full meeting in April will be hybrid. Anyone who wishes to participate in person may do so.
- Discussed additional educational activities that NCSDR could engage in that could result in information about how the public can make changes in their daily life for optimal and healthy sleep and circadian biology.
- Emphasized the importance of integrating meal timing and sleep into relevant recommendations by the USDA & HHS.
- Expressed strong interest in determining how the research community can contribute effectively, in coordination with NCSDR, to navigating this complex and important landscape of sleep, circadian biology, nutrition, and eating.
- SDRAB member Ms. Alexandra Wharton highlighted ongoing activities to promote sleep issues among employees with visible or invisible disabilities.