Sleep Disorders Research Advisory Board

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NATIONAL CENTER ON SLEEP DISORDERS RESEARCH NATIONAL HEART, LUNG, AND BLOOD INSTITUTE Sleep Disorders Research Advisory Board Meeting Minutes August 27, 2010 TABLE OF CONTENTS Attendees Remarks Introduction Adoption Of Minutes From The April 14, 2009 SDRAB Meeting NCSDR Director's Report: Michael Twery, PhD Trans-NIH and Federal Agency Updates Closed Session 2011 Sleep Research Plan Overview Sleep Research Plan: Invited Presentations and Stakeholder Comments Sleep Research Plan Development and Discussion Action Items Future Meeting Certification Sleep Disorders Research Advisory Board Page BOARD MEMBERS PRESENT Dr. Charles Czeisler, Chair Ms. Ann Austin Dr. Mercedes Carnethon Dr. Ronald Chervin Ms. Karen Cushing Dr. Leszek Kubin Dr. Sairam Parthasarathy Dr. Daniel Rudic Dr. Catherine Vena Dr. Michael Vitiello Mr. Gagandeep Walia Mr. Robert Waterman BOARD MEMBERS ABSENT None EX OFFICIO MEMBERS PRESENT Dr. Michael Twery, NHLBI, Executive Secretary FEDERAL LIAISON REPRESENTATIVES PRESENT Dr. Lawrence Baizer, NIAAA, NIH Dr. Giovanni Cizza, NIDDK, NIH Dr. Janet Croft, NCCDPHP, CDC Dr. Harold Gordon, NIDA, NIH Dr. Robert Greene, VHA, Department of Veterans Affairs Dr. Lynne Haverkos, NICHD, NIH Dr. Mack Mackiewicz, NIA, NIH Dr. Sue Mardin, NINR, NIH Dr. Paige McDonald, NCI, NIH Dr. Merrill Mitler, NINDS, NIH Ms. Andrea Piani, Census Bureau, Department of Commerce Dr. Roger Rosa, NIOSH, CDC Dr. Corinne Silva, NIDDK, NIH Dr. Barbara Sorkin, NCCAM, NIH Dr. Aleksandra Vicentic, NIMH, NIH Dr. Nancy Wesensten, MEDCOM, Department of Defense FEDERAL EMPLOYEES PRESENT Dr. Beth Ansel, NCMRR/NICHD, NIH Dr. Carole Davis, FDA Dr. Rosemarie Filart, NCRR, NIH Mr. Peyvand Ghofrani, NHLBI, NIH Ms. Kaitlyn Harrington, NHLBI, NIH Dr. Indira Jevaji, ORWH, NIH Dr. Laura Kienker, Office of Naval Research Dr. Aaron Laposky, NHLBI, NIH Dr. Daniel Lewin, NHLBI, NIH Dr. Wilbur Malloy, DOD Dr. Sheri Parker, Office of Naval Research Dr. Letitia Presley-Cantrell, CDC Dr. Nancy Shinowara, NICHD, NIH Dr. Brad Wise, NIA, NIH MEMBERS OF THE PUBLIC PRESENT Mr. David Cloud, NSF Dr. John Feeney, Vanda Pharma Dr. Julie Flygare, Wake Up Narcolepsy Dr. Ed Grand, ASAA Dr. Patricia Higgins, Narcolepsy Network Dr. Clark Lee, Health and Homeland Security/University of Maryland Dr. Jeff Hickman, Virginia Tech Transportation Institute Dr. Joni Phillips, SELF Dr. Richard Rosenberg, AASM Dr. Jim Walsh, SRS Dr. Phyllis Zee, Northwestern/AAN Return to Table of Contents REMARKS: DIRECTOR, DIVISION OF LUNG DISEASES, NHLBI: James Kiley, PhD The National Center on Sleep Disorders Research (NCSDR) is firmly established within NHLBI both scientifically and organizationally. The Center is currently staffed better than at any previous time with 3 Full Time professional staff, 1 Clinical Trials Specialist, and administrative support staff. The Center continues to stimulate programmatic coordination with other divisions of NHLBI, NIH Institutes and Centers, and other government agencies. The revision of the sleep research plan is a priority for NCSDR. Return to Table of Contents INTRODUCTION, Michael Twery, PhD The meeting was called into session at 8:30am as previously announced in the Federal Register [FR Doc. 2010-15480]. The Board and audience were notified that the meeting audio would be recorded. 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). Members of the Board were informed of their status as special government employees during the meeting and that conflict of interest guidelines apply to conduct. Return to Table of Contents ADOPTION OF MINUTES FROM THE APRIL 14, 2009 SDRAB MEETING, Acting Chair A motion to adopt the minutes of the preceeding in-person meeting on April 14, 2009 without amendment carried unanimously. Return to Table of Contents NCSDR DIRECTOR'S REPORT: Michael Twery, PhD NCSDR is located within the NHLBI and fosters the coordination of NIH sleep and circadian research programs through the Trans-NIH Sleep Research Coordinating Committee (SRCC), Federal Agency partners, SDRAB, individual researchers, community organizations, and other constituencies. Preliminary analysis of FY 2010 RCDC Sleep Disorders Research Sleep research is an NIH-wide concern with sleep category grants supported by 23 of 27 NIH Institute and Centers. The success rate of sleep applications from trainees, new investigators, and established investigators was generally similar. Training applications (T, K, F) categorized as sleep are submitted in numbers smaller than expected given the number of full scale research (Rxx, Pxx) applications and when compared to NIH-wide averages. An analysis of FY2010 funding opportunity announcements revealed that initiatives appropriate for consideration by sleep researchers are numerous. Selected examples of FY2010 NIH activities include: Sleep and Social Environment: Basic Biopsychosocial Processes (R21/R01) RFA-HD-11-102, RFA-HD-11-101 (OppNET). Pending review. Reducing Cardiovascular Disease Risk Through Treatment of Obstructive Sleep Apnea (U34) RFA-HL-10-023. Two grants awarded. Circadian-Coupled Cellular Function in Heart, Lung, and Blood Tissue (R01) RFA-HL-09-012. Six grants awarded. Researchers were encouraged to stay informed regarding NIH research directions, and to submit grant applications for NIH competition. Return to Table of Contents TRANS-NIH AND FEDERAL AGENCY UPDATES NIH and Federal Agency Representatives described programs and areas of interest within their organization in relation to sleep research. The following institutes and agencies reported: CDC, VA, NINDS, NIA, NIAAA, NCRR, NICHD, NIOSH, NIDDK, NCI, NIMH, NCCAM, NIDA, and DOD. Dr. Czeisler requested that representatives submit brief written reports to the Board through NCSDR. Return to Table of Contents CLOSED SESSION The Board met in closed session briefly to consider the election of a new Chair for FY2011. Dr. Charles Czeisler was elected and is expected to serve as Chair for the balance of his term ending June 30, 2011. Return to Table of Contents 2011 SLEEP RESEARCH PLAN OVERVIEW, Michael Twery, PhD The process, timeline, and format of an updated NIH Sleep Research Plan was described. As called for in legislation (42 USC Sec. 285b-7), the NIH will develop an NIH Sleep Research Plan in consultation with SDRAB and the Director of NCSDR. The current research plan process launched with the publication of a Request for Information (RFI): Sleep Disorders Research Plan (NOT-HL11-107) in June 2010. The RFI response included over 200 comments including patients (40%), researchers (40%), and organizations (20%). Selected highlights noted: The need to enhance the sleep disorder training of health care providers The need to enhance sleep research training and workforce development. The need to improve therapeutic approaches. Return to Table of Contents SLEEP RESEARCH PLAN: INVITED PRESENTATIONS AND STAKEHOLDER COMMENTS Sleep Research Society, Dr. James Walsh. Sleep Research Network, Dr. Allan Pack. American Academy of Sleep Medicine, Dr. Patrick Strollo. Society for Research on Biological Rhythms, Dr. Joseph Takahashi. American Sleep Apnea Association, Mr. Edward Grandi. Narcolepsy Network, Ms. Patricia Higgins. National Sleep Foundation, Mr. David Cloud. Discussion of the public comments and questions included the following: Dr. Phyllis Zee (American Neurological Association) noted the need for standard sleep research measures in large neurological cohort studies. Ms. Julie Flygare (Wake Up Narcolepsy) urged a need for more funding for research and awareness. Return to Table of Contents SLEEP RESEARCH PLAN DEVELOPMENT AND DISCUSSION, Chair/Board Members The Board seeks to develop implementable research plan recommendations that could be undertaken over the next 5 years. The Board received and discussed general directions for research identified by the transNIH Sleep Research Coordinating Committee. A consensus platform of five over-arching provisional goals emerged through a roundtable process of discussion among members, stakeholders, and other meeting participants. Improve understanding of optimal circadian and sleep (CaS) function and mechanisms across the lifespan and the influence of CaS regulatory systems on human health and function; and evaluate the impact of chronic exposure to CaS disorders and dysregulation, including sleep restriction, circadian misalignment, and recurrent displacement of sleep-wake and circadian cycles (i.e., social jet lag), on health and safety. Define the links between CaS regulation, CaS function and CaS disorders in neural and peripheral tissue and their role in development, health, and disease pathogenesis and disability. Improve the prevention, diagnosis and personalized and safe treatment of sleep deprivation, circadian misalignment, CaS dysregulation and CaS disorders. Accelerate the translation and dissemination of CaS concepts (research, health care, policy, community). Ensure an adequate scientific research workforce to accomplish these goals by strengthening career research training and research mentoring activities in scientific and medical research related to CaS science and CaS dysregulation and disorders. Return to Table of Contents ACTION ITEMS TransNIH Sleep Research program staff and representatives from other Federal agency partners are invited to submit statements summarizing sleep research activities. The Board will identify ad hoc consultants and subject matter expert volunteers as needed for background on exceptional opportunities for sleep research in preparation for subsequent Board meeting discussion. NCSDR will discuss with CDC staff the possibility of updating an existing resource listing datasets with sleep information. Return to Table of Contents FUTURE MEETING November 12, 2010, conference call [FR Doc. 2010-27318] December 10, 2010, in-person [FR Doc. 2010-27318] January 4, 2011, conference call [FR Doc. 2010-29523] These Minutes will be presented to the full Board at its next regularly scheduled in person meeting for consideration, amendment as approved, and formal adoption. CERTIFICATION I hereby certify that the foregoing minutes are accurate and complete. Charles Czeisler, PhD, MD Chair, Sleep Disorders Research Advisory Board Michael Twery, PhD Executive Secretary, Sleep Disorders Research Advisory Board Return to Table of Contents

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