The Sleep Disorders Research Advisory Board (SDRAB) convened on June 21 - 22, 2018. SDRAB is a Federal Advisory Committee established by the NIH Revitalization Act of 1993.
BOARD MEMBERS PRESENT
Dr. Patrick Strollo, Chair
Dr. Ravi Allada
Dr. Mona El-Sheikh
Dr. Clete Kushida
Dr. Ketema Paul
Ms. Susan Plawsky
Dr. Naresh Punjabi
Ms. Nancy Rothstein
Ms. Linda Secretan
Dr. Virend Somers
Dr. Julea Steiner
Dr. Kenneth Wright
Dr. Michael Twery, NHLBI, Executive Secretary
BOARD MEMBERS ABSENT
Ad HOC MEMBERS PRESENT
Dr. Eve Van Cauter
Dr. Mariana Figueiro
Dr. Judette Louis
Dr. Wendy Troxel
EX OFFICIO MEMBERS PRESENT
Dr. Michael Twery, NHLBI, Executive Secretary
FEDERAL EMPLOYEES PRESENT
Dr. Marishka Brown, NHLBI, NIH
Mr. Peyvand Ghofrani, NHLBI, NIH
Dr. Janet He, NINDS, NIH
Dr. Nancy Jones, NIMHD, NIH
Dr. Aaron Laposky, NHLBI, NIH
Dr. Lanay Mudd, NCCIH, NIH
Dr. Dana Schloesser, OBSSR, NIH
Ms. Kate Winseck, ODP, NIH
MEMBERS OF THE PUBLIC PRESENT
Ms. Karla Dzienkowski, Restless Legs Syndrome Foundation
Mr. Peter Herzog, Restless Legs Syndrome Foundation
Dr. Peter Mansbach, Circadian Sleep Disorders Network
Dr. Jennifer Martin, American Academy of Sleep Medicine
Dr. Selena Nguyen-Rodriguez, California State University
Mr. Kris Schanilec, Restless Legs Syndrome Foundation
INTRODUCTION, Dr. Michael Twery
- The meeting was called into session at 1:00 pm, [FR Doc. 2018-11959].
- The Sleep Disorders Research Advisory Board (SDRAB) is a Federal Advisory Committee established by the NIH Revitalization Act of 1993 (42 USC Sec. 285b-7).
- The Board was informed of their status as special government employees and that conflict of interest guidelines require that members recuse themselves from any discussions presenting the potential appearance of a covered conflict.
DEPARTING SDRAB MEMBERS
- NCSDR Director, Dr. Michael Twery, presented certificates of appreciation to Drs. Strollo, Wright, Allada, El-Sheikh, Sommers, Kushida, Punjabi and Mrs. Rothstein whose Board terms expire on June 30, 2018.
NCSDR DIRECTOR's REPORT, Dr. Michael Twery
- The SDRAB Charter and legislative charge to NCSDR was presented.
- Summary statistics and trends of sleep and circadian research grant support was presented with the conclusion that support for these scientific domains exists NIH-wide.
- Summary data on the research training “pipeline” was presented including details for the support of Early State Investigators (ESI) and non-ESI investigators.
- Updates presented on the evolution of NIH policies governing clinical trials and the potential significance of policy changes to sleep and circadian researchers.
NIH PATHWAYS TO PREVENTION PROGRAM, Ms. Kate Winseck
- NIH Office of Disease Prevention’s (ODP) representative described the mission and strategic vision of ODP, goals and expectations of the Pathways to Prevention (P2P) Workshop Program; P2P workshops that have been completed so far; process for approval of a new workshop; expected outcome areas for a workshop; and impact of the P2P program.
- SDRAB discussed potential topics for a P2P workshop on sleep health—areas discussed included sleep in children and adolescents, Alzheimer’s disease, awareness and improved diagnosis of sleep disorders, shift work, sleep in Intensive Care Unit (ICU) environment and hospitals, and biomarkers.
UPDATES FROM TRANS-NIH INSTITUTES AND CENTERS
- Trans-NIH sleep program representatives presented brief updates of their IC specific sleep and circadian activities.
- National Center for Complementary and Integrative Health (NCCIH): primary interest with regards to sleep research (i.e. sleep and pain) and stimulating that research by multiple funding mechanisms.
- National Institute on Minority Health and Health Disparities (NIMHD): interests include strategies to increase integration of sleep with health disparities research.
- National Institute of Neurological Disorders and Stroke (NINDS): highlighted NINDS support of research into neuro-regulation of sleep in both health and disease.
- National Heart Lung and Blood Institute (NHLBI): highlighted the integration of sleep and circadian science into programs relevant to NHLBI’s mission (e.g. microbiome); new collaborations with NIH ICs (NINDS, NIA, NICHD, etc.) supporting inter-disciplinary workshops and FOA programs; new administrative supplement FOA supporting Down’s Syndrome; opiate research and sleep; and an ongoing study of sleep apnea outcomes in pregnancy with regards to sleep, breathing, cardiopulmonary, and metabolic risk.
- National Cancer Institute (NCI): described NCI interest in circadian and sleep effects on the immune system and inflammation, and circadian clock as a biological variable for health and disease research.
PATIENT-ORIENTED ISSUES AND DISCUSSION, Patient Membership of SDRAB
- Members representing sleep disorder patients presented a statement underscoring the importance of including sleep disorders and patient-oriented studies into discussions of the sleep disorders research plan revision.
SLEEP DISORDERS RESEARCH PLAN REVISION
- The Board discussed draft recommendations for the sleep disorders research plan. Feedback was solicited with regard to advancing science, healthcare, well-being, and public health and safety.
PUBLIC AND STAKEHOLDER COMMENTS AND DISCUSSION, DAY 1
- Public stakeholders expressed the need for inclusion of circadian disorders on the NHLBI website and how doing so would add to the validity of circadian rhythm disorders.
- SDRAB recommended that the development of sleep disorder web content be discussed further at a future Board meeting.
- The activities of Project Sleep with regards to narcolepsy research at the NIH were discussed. Value of increasing inclusion of sleep disorders into public health realm was highlighted.
DENTAL SLEEP MEDICINE IN THE US ARMY, Dr. Michael Pagano
- Described the role of obstructive sleep apnea (OSA) within army medicine for readiness and performance. Self-report shows insufficient sleep and comorbid OSA and insomnia as well as parasomnias; incidence rate of OSA in US Military is increasing and coordination of care (diagnosis, treatment, and monitoring compliance) is needed.
- Dentist training program is designed to make every dentist in the army aware of sleep disordered breathing and part of the collaborative healthcare team.
RESTLESS LEGS SYNDROME FOUNDATION, Dr. John Winkelman
- Dr. Winkelman provided an overview of Restless Legs Syndrome (RLS) and the role of sleep and circadian biology in RLS.
- National RLS opioid registry was described as were preliminary data from the registry.
AMERICAN ALLIANCE FOR HEALTHY SLEEP, Ms. Melissa Clark
- A newly created non-profit membership organization for patients with sleep disorders, providers, and others interested in healthy sleep. Described were mission and overarching goal of the organization, current priorities of the organization and planned future activities.
RESEARCH HIGHLIGHT: SLEEP-GUT MICROBIOME CONNECTION, Dr. Alyssa Brooks and Dr. Nancy Ames
- Intramural researchers from the NIH Clinical Center described their research focusing on the interaction between the gut microbiome and sleep. This included a summary of studies about sleep and the microbiome in animals and humans, following sleep deprivation and sleep disruption.
SLEEP RESEARCH PLAN
SDRAB continued discussion of the sleep research plan across multiple areas.
- Basic sleep and circadian science in relation to molecular signatures and biomarkers, energy metabolism, cognitive impairment, immunology, microbiome, mental health, substance abuse, and women’s health; the spectrum and interplay of basic, translational, and clinical research across sleep disorders research; and understanding how sleep and circadian health impacts disease and how to intervene to affect relevant sleep and circadian pathways to affect health of the body.
- Transforming healthcare and the role of transdisciplinary science that integrates improving sleep and circadian physiology with other medical conditions; development of valid biomarkers to broadly and more readily evaluate sleep and circadian health in patient treatment and precision circadian and sleep medicine and for use in large cohort studies and clinical trials.
- Advancing well-being that includes role for accurate and validated sleep and circadian health wearable technologies that are actionable for the consumer to promote health; light and health for promotion of bodily health and circadian robustness; circadian medicine (e.g. role of disturbed circadian rhythms in health and disease); and rigor and reproducibility across sleep and circadian science.
- Public health and safety including addressing the health and societal impact of sleep deficiency and circadian dysfunction; sleep and circadian appropriate times to enter patient rooms in hospitals, and other down-stream approaches to sleep and circadian health; sleep and circadian health across the lifespan and populations; studying and addressing bi-directional social, environmental, and policy level impacts on and of sleep and circadian health (; role of implementation science; role of enablers of sleep disruption.
- Enhancing sleep and circadian science training including transdisciplinary training between sleep and circadian rhythms with the spectrum of public health and safety sciences and critical need for effective, modern, and diverse models of training at various levels to address the need and prepare the research field now and the next two decades.
- Next steps in development of the sleep disorders research plan were described; they include further consultation with SDRAB members, review and evaluation by the trans-NIH Sleep group, review and opportunity for input by IC directors at the NIH, final consideration and approval by the director of the NIH, and publication.
PUBLIC AND STAKEHOLDER COMMENTS AND DISCUSSION, DAY 2
- American Academy of Sleep Medicine is preparing research summary publications on 1) sleep deficiency/sleep disorders and Alzheimer’s disease, and 2) drowsy driving.
- SDRAB discussed clinical practice guideline development process, challenges, and requirements including adequacy and effectiveness of research.
GENERAL DISCUSSION, Dr. Gary Gibbons
- The NHLBI Director answered questions and discussed a variety of topics with the board. Main points of discussion included the NIH All of Us program, the potential role of provider organizations and health system Electronic Health Records in research, the development of personal sensor technologies; the role of the patient community in the NHLBI mission; the importance of implementation science and research to address the real problems that patients face.
- Dr. Gibbon’s also discussed the importance of NCSDR in its facilitation of sleep and circadian research both across the NIH and other federal agencies. The importance of the Board was noted. assisting NIH (NCSDR) with moving the fields of sleep and circadian biology forward.
FUTURE PUBLIC CONFERENCES
- Sleep and Women’s Health open public conference (Oct 17-18, 2018) at NIH Natcher Conference Center; researchers, patients, and stakeholders in women’s family and children’s health.
In-person SDRAB meetings will continue with two meetings each year. Virtual meetings may be scheduled - as needed. Meeting announcements are formally announced by publication in the Federal Register.