Sleep Disorders Research Advisory Board (SDRAB) Meeting – August 4, 2022

The Sleep Disorders Research Advisory Board (SDRAB) convened virtually on Thursday, August 4, 2022. SDRAB is a Federal Advisory Committee established by the NIH Revitalization Act of 1993. The meeting opened at 1PM ET and closed at 4PM ET. Dr. Gabriel Haddad presided as Chair.

Meeting Summary

BOARD MEMBERS PRESENT

Dr. Gabriel Haddad, Chair
Dr. Si Baker-Goodwin
Ms. Ebony Lay
Dr. Alberto Ramos
Dr. Tom Scammell
Dr. Esra Tasali
Ms. Alexandra Wharton

BOARD MEMBERS ABSENT

Dr. Jeffery Durmer
Dr. Erik Herzog

EX OFFICIO MEMBERS PRESENT

Dr. Marishka Brown, NHLBI, Executive Secretary
Dr. Yejun (Janet) He
Dr. Shahla Jilani
Dr. Donald Shell

FEDERAL EMPLOYEES: 32 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 45.

CALL TO ORDER, Dr. Marishka Brown

• The meeting was called into session at 12:00 PM ET as announced in the Federal Register on July 1, 2022,[Federal Register 2022-14080]. This meeting was fully open to the public according to provisions of US code and Federal Advisory Committee Act as amended. The Chair, Dr. Haddad introduced members of the Sleep Disorders Research Advisory Board (SDRAB) and the Ex Officio members.

DIRECTOR’S REPORT FROM THE NATIONAL CENTER ON SLEEP DISORDERS RESEARCH, Dr. Marishka Brown

• Described the roles and future goals of the SDRAB in advising NCSDR on activities related to sleep and circadian research, updated the board about the funding landscape of sleep and circadian research across the NIH at various ICs for fiscal year 2022.
• Highlighted the NCSDR conducted panel meeting at the annual Sleep meeting about the Sleep Research Plan.
• Introduced the scientific topics for the meeting and discussed some highlights of the NIH programs focused on those topics:
  • Maternal Health: IMPROVE program
  • Substance Use Disorders: HEAL
• Developing research concepts that align with the sleep research plan were described. Health initiative strategic framework and its goals were discussed on topics like chronotherapy, chronic disease (type 1 diabetes and sleep), and climate change with sleep research opportunities further highlighted.
• Describe the new NIH scientific data sharing policies which will be effective starting January in 2023, and various resources were shared.
• Information about National Sleep Research Resource (NSRR) ongoing webinars and the resources were provided and discussion on how NSRR is advancing Sleep Research through data sharing.
• Reiterated the definitions and processes for clinical trials allowed or not allowed under NIH policies were discussed.
• Leadership Lens participation for the next SDRAB meeting was communicated: Director of NIMHD, Dec 1, 2022, meeting.
• Upcoming national meetings and conferences including Neuroscience 2022 annual meeting was highlighted and SDRAB was informed about NCSDR’s activities including the DataBlitz and booth sessions.

Sleep and Pregnancy, Maternal and Infant Health Update:

Ghada Bourjeily, MD, Professor of Medicine, Warren Alpert Medical School of Brown University, Associate Chief for Academic Advancement and Research for Women's Services, Director of Research for Women's Services, Women's Medicine Collaborative, Brown University, Providence, RI

• Discussed the growing concern regarding pregnancy-related mortality and the health during pregnancy and maternal health, with US showing significantly higher maternal health mortality compared to other developed nations. Causes of pregnancy-related death and a striking difference by race and ethnicity in the US were discussed.
• The role of sleep during pregnancy and maternal health with more details on insomnia prevalence and predictors during pregnancy compared to pre- and to some extent post-pregnancy. Physiological changes in pregnancy that may predispose to SDB were summarized, with studies and data about prevalence of objective SDB.
• Sleep disorders and suboptimal sleep including short sleep duration that account for a number of causes of material morbidity and mortality were described. 
• Addressing sleep problems and the effect on maternal health, research gaps, and opportunities and future directions were discussed.
• SDRAB discussed topics including screening for sleep by OB/GYN, mental health and post-partum depression including interventions in development with light therapy, and studies showing relationship of sleep issues with depression during peri-pregnancy periods.

Federal Stakeholder Update:

Shahla Jilani, M.D., Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Washington, DC

• Origins and development of scope of HHS initiative on substance exposure in the mother-infant dyad were described, with overarching emphasis on improving long term care. Gaps in the areas of standardization of terminology, treatment and care protocols, administrative coding, surveillance/public policy, clinical and epidemiological research criteria, clinical definitions, and programs and resources were discussed. Particularly, efforts to standardize the clinical definition of opioid withdrawal in the neonate.
• Awareness of the care gaps and identified priorities (clinical definitions, surveillance, etc.) and their effects on downstream policies. Updated the initiatives taken regarding bedside definition and clinician activities, programs and services by identifying key stakeholders and experts and using a modified Delphi methodology.
• Results showing standard definition needed and historical gap in how Neonatal Abstinence Syndrome (NAS) and Neonatal Opioid Withdrawal Syndrome (NOWS) had been identified in the field and literature, and recommended criteria for clinical definition of opioid withdrawal in the neonate.
• Updated the Board regarding the developed definition and the key components of clinical criteria recommendations, bioethical principles for the clinical definition which were developed in collaboration with the advisory board and bioethicists in the field with considerations for mother and neonate.
• Lastly, discussed implementation and future steps across clinical, research, and program and policy domains were communicated. Conveyed that OASH looks forward to working with more stakeholders and experts. 

Leadership Lens: 

Roger Little, Ph.D., Deputy Director of the Division of Basic Neuroscience and Behavioral Research, National Institute of Drug Abuse (NIDA), NIH

• The primary topic was sleep and substance use disorders and addiction, and the relationship of circadian rhythm and addiction.
• Elaborated the role of sleep circadian aspects, withdrawal and reward systems, and the mechanisms involved as research examples. 
• Described sex differences in circadian rhythm regulation that could in part explain sex differences in addiction.
• Described how restoring circadian rhythms positively alters addiction behaviors and how circadian rhythms and addiction share signaling systems.
• Indicated the importance of chronomedicine as a strategy to medicate and treat opioid addiction.
• Updated regarding the funding opportunities in chronomedicine research area. 
• SDRAB discussed translational research and future opportunities in chronotherapy.

HEAL Program Update:

Aaron Laposky, Ph.D., Program Director, Chronobiology and Ventilatory Control, National Center on Sleep Disorders Research, NHLBI, NIH

• Overview of the HEAL program, NIH’s response to the opioid epidemic public health crisis, and its structure and goals.
• Sleep, circadian, and ventilatory control aspects were described. The RFA focusing on basic and clinical programs to study prevention of sleep deficiency improves OUD and treatment outcomes were used as an exemplar of the ventilatory control program.
• Potential concepts under discussion include sleep and circadian predictors of OUD treatment response and outcomes, and mechanisms and treatment responses about sleep and pain.
• Future goals at the intersection of opioid abuse, sleep apnea, and maternal health were outlined.   

HEALthy Brain Child Development Project Update: 

Michelle Freund, Ph.D., Director, HEALthy Brain Child Development (HEALthy BCD) Project, National Institute of Drug Abuse (NIDA), NIH  

• Overview of HBDC: longitudinal study about development of children from pregnancy until ages 9-10; multimodal study and aims to characterize neurodevelopmental trajectories from the large sample.
• Structure and geographical spread of the study, methodological designs, recruitment goals, schedule of study timeline events and procedures, including biospecimen collection schedule, were described. The biospecimens are currently not budgeted to be analyzed and researchers are invited to submit grant applications to utilize all data collected during the study.
• SDRAB members asked questions on how sleep and sleep disorders may be further integrated (e.g., RFA to look at sleep of the pregnant mothers).  Researchers’ opportunities were presented, as those with interest could submit ancillary proposals by pairing with a member of the consortium. 

Scientific Focus Presentation:

Colleen A. McClung, Ph. D., Professor of Psychiatry and Clinical and Translational Science, University of Pittsburgh Medical School, Pittsburgh, PA

• Overview of the associations between addiction and circadian rhythm disruption in humans and animal models.
• Described shift work during pregnancy and prenatal circadian disruption, role of disrupting molecular function via disrupting circadian rhythms.
• Summarized the effects and the relationship biological sex. 

Advisory Board Discussion

The SDRAB discussion and recommendations focused on:

• The role of the human biosamples (HEALthy Brain Child Development Project) to perform real-world research.
• Importance of integrating sleep and circadian aspects into broad areas of research, and incorporation of improved and more integrated assessments of sleep and circadian phase.