- ADOPTION OF MINUTES FROM THE April 30, 2012 SDRAB MEETING, Chair
- DEPARTING SDRAB MEMBERS
- NCSDR DIRECTOR'S REPORT, Dr. Michael Twery
- NHLBI'S OFFICE OF COMMUNICATIONS UPDATE, Ms. Morgan Jones
- SLEEP and CARDIOVASCULAR RESEARCH DIRECTIONS, Dr. Catherine Stoney
- TRANS-NIH INSTITUTE, CENTER, AND OFFICE UPDATES
- CLOSED SESSION
- Research Highlight: SLEEP AND HEALTH DISPARATIES, Dr. Girardin Jean-Louis
- CDC SLEEP HEALTH SURVEILLANCE, Dr. Anne Wheaton
- NIH Office of SCIENCE EDUCATION, Ms. Cynthia Allen and Ms. Lisa Strauss
- Update: AASM/SRS JOINT RESEARCH TASK FORCE, Dr. Phyllis Zee
- PROGRAM DEVELOPMENT IN THE NHLBI, Dr. James Kiley
- NHLBI CLINICAL RESEARCH INITIATIVE PLANNING PROCESS, Dr. Gail Weinmann
- PUBLIC COMMENTS
- HEALTH CARE DELIVERY RESEARCH, Dr. Kate Bent
- SDRAB MEMBERSHIP
- INTEGRATING SLEEP RESEARCH PLAN RECOMMENDATIONS
- FUTURE MEETINGS
BOARD MEMBERS PRESENT
Dr. Sairam Parthasarathy, Acting Chair
Dr. Mercedes Carnethon (Web/Phone)
Dr. Ronald Chervin
Ms. Julie Flygare
Dr. Girardin Jean-Louis
Dr. Leszek Kubin
Ms. Kathy Page
Ms. Ila Sensenich
Dr. Catherine Vena
Dr. Michael Vitiello (Chair, Web/Phone)
Mr. Gagandeep Walia
BOARD MEMBERS ABSENT
Dr. Daniel Rudic
EX OFFICIO MEMBERS PRESENT
Dr. Rosalind King, NICHD, NIH
Dr. Mack Mackiewicz, NIA, NIH
Dr. Merrill Mitler, NINDS, NIH
Dr. Michael Twery, NHLBI, Executive Secretary
Dr. Aleksandra Vicentic, NIMH, NIH
FEDERAL LIAISON REPRESENTATIVES PRESENT
Dr. D. Lee Alekel, NCCAM, NIH
Dr. Bill Elwood, OBSSR, NIH
Dr. Lindsey Grandison, NIAAA, NIH
Dr. Harold Gordon, NIDA, NIH
Dr. Indira Jevaji, ORWH, NIH
Dr. Paige McDonald, NCI, NIH
Dr. Corinne Silva, NIDDK, NIH
Dr. Barbara Sorkin, ODS, NIH
Dr. Xenia Tigno, NINR, NIH
Ms. Cynthia Allen, OSE, NIH
Ms. Maria Barhams, NHLBI, NIH
Dr. Letitia Cantrell, CDC
Mr. Peyvand Ghofrani, NHLBI, NIH
Ms. Morgan Jones, NHLBI, NIH
Dr. Aaron Laposky, NHLBI, NIH
Dr. Daniel Lewin, NHLBI, NIH
Dr. Christine Melchior, CSR, NIH
Dr. Kate Stoney, NHLBI, NIH
Ms. Lisa Strauss, OSE, NIH
Dr. Anne Wheaton, CDC
Dr. Ellen Witt, NIAAA, NIH
MEMBERS OF THE PUBLIC PRESENT
Dr. James Andry (Web/Phone)
Mr. David Cloud, NSF (Web/Phone)
Mr. James Fadden, Circadian Sleep Disorders Network
Ms. Kristin Jones, NSF (Web/Phone)
Mr. Peter Mansbach, Circadian Sleep Disorders Network
Dr. Janet Mullington, SRS (Web/Phone)
Dr. Allan Pack
Dr. Patrick Strollo, AASM
Dr. Mariana Szklo-Coxe (Web/Phone)
Dr. Ron Szymusiak
Mr. Ted Thurn, AASM
Dr. Jim Walsh, SRS
Dr. Nathaniel Watson, AASM
Dr. Phyllis Zee, SRS
7 persons utilized Webinar functionality to view presentations in real time.
29 persons joined the meeting via phone teleconference.
- The meeting was called into session at 8:30 am, [FR Doc. 2013-00269].
- 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. If at any time there is a potential COI, each person should excuse themselves and go outside until the conflict has concluded.
- Those participating via telephone were introduced by Dr. Twery. SDRAB and Trans-NIH liaison members introduced themselves. 4 new members joined SDRAB, 3 patient advocates and 1 scientific member.
- Dr. Parthasarathy acted as Chair in lieu of Dr. Vitiello (web/phone) who unexpectedly was prevented from attending in-person due to severe weather.
- The minutes of the previous meeting (teleconference) on April 30, 2012 was unanimously approved by the Board without amendment.
NCSDR director presented certificates of appreciation to Drs. Chervin, Rudic, and Vitiello whose Board terms would expire on June 30, 2012.
- A summary of NCSDR activities in 2012 including workshops, conference sessions, published letters, and invited presentations was presented.
- A summary of accomplishments from the landmark Sleep Heart Health study (1994-2012) and the of 14 years of NIH support was presented.
- 81 publications with 128 participating investigators/authors.
- >6500 citations, with on average 50 citations per publication.
- Update: sleep health as a new topic in Healthy People 2020.
Selected examples of the national data on which national goals for sleep health were presented including percent of US adults obtaining sufficient sleep by race and ethnicity, family income, and family type.
- TransNIH support of sleep and circadian research. Analysis of the NIH grant portfolio demonstrated that the NIH-wide commitment to support for sleep and circadian science extends to nearly all mission areas.
- NIH Sleep Research Plan, portfolio analysis.
- Board members evaluated 692 active sleep and circadian grants in FY 2011 and mapped them across the 5 goals of the NIH sleep disorders research plan.Â Intensity of research varied between basic (goal 1)> clinical (goal 2) > sleep medicine (goal 3) > translational (goal 4).Â This analysis will repeated in future years and compared to the 2011 baseline.
- Funding opportunity announcements relevant to sleep and circadian research (NIH-wide, 2011) were categorized and presented with respected to specific goals in the NIH Sleep Research Plan.
- Overview of communication channels and methods utilized to connect the public and grantee communities.
- NHLBI launched the first ever twitter event for Sleep in FY2011. The 1 hour event produced > 761 tweets with an international audience.
- Living with and Managing Sleep Apnea is a new NHLBI dissemination product on Youtube that has been well received with >40,000 views to date.
- Release of the 2011 NIH Sleep Disorders Research Plan was disseminated by NHLBI using press releases, newsletters, and podcasts (NIH Radio).
- Investigators, institutions, and professional societies invited to coordination with the NHLBI Office of communication on the dissemination of sleep and circadian scientific advances.
- Summarize ongoing data collection in large epidemiological research studies and focus on the role of sleep in cardiovascular disease risk
- Opportunities for collaborative analyses between sleep researchers and the ongoing cohort studies were highlighted.
- Trans-NIH sleep program representatives presented brief updates of sleep and circadian activities.
- OBSSR described the OppNet program which included sleep and circadian research funded by R21 and K18 mechanisms
- NCCAM highlighted their interest in the role of sleep in mindfulness, meditation, pain perception, and health and well-being as an integral part of the Institute mission.
- NIA summarized a workshop and initiative centered around the topic of circadian clocks, aging, and dementia.
- NIDA outlined several connections between sleep and substance abuse.
- NIMH summarized its support of 94 sleep grants in 2011 and FOAs related to sleep. E.g. Collaborative R34s for Pilot Studies of Innovative Treatments in Mental Disorders
- NINDS highlighted its role in supporting chronic fatigue and sleep research.
- NCI highlighted circadian disruption research and how sleep problems contribute to obesity, cancer risk, cancer progression, and energy balance.
- NIDDK noted several studies underway linking circadian biology to obesity and metabolism.
- NICHD described sleep-related publications and summarized active FOA, funded clinical trials, and epidemiology underway linking sleep to disease.
- NINR described interest in understanding sleep across the lifespan, health promotion, and disease prevention. The institute supports a 1 week research training summer camp each year in sleep science
- NIAAA stated that research at the intersection of sleep/circadian with alcohol abuse is supported, and that two alcohol and sleep related FOAs were published.
- Office of Dietary Supplements is within the Office of Disease Prevention at NIH’s Officer of the Director. ODS is interested in exploring opportunities for sleep and circadian related co-funding and program development.
- Office of Research on Women’s Health described interest in research around women’s health including PCOS, sleep apnea, and fibromyalgia.
- As announced in the Federal Register, the Board met briefly in closed session to consider the nomination of a new Chair since Dr. Vitiello’s term would end on June 30, 2012. Immediately afterwards, the meeting resumed in public session and the Board announced that Dr. Sairam Parthasarathy had been nominated to serve as the next Chair starting on July 1, 2012.
- Differences between races in diagnosis of sleep disorders including OSA, insomnia, and RLS were described, and it was noted that these differences should be considered when looking at national data. Description of differences in reporting of sleep problems and diagnosis of sleep disorders and adherence to physician recommendations were described; obesity and daytime sleepiness are two factors that appear to predict seeking out treatment for OSA.
- Methodological approaches to disparities research were described including surveys and focus groups; community endorsement was identified as key to sustainability of interventions
- Community-based research will be essential to understanding rates of persons at risk for OSA, barriers to seeking treatment, and remedying those barriers in the language of the community.
- An intervention study to promote adherence to sleep apnea treatment among blacks with metabolic syndrome was described including examples of interventions and best practices to mitigate sleep health disparities
- Goals of CDC’s Sleep Health Program were described. The presentation was focused on one of those goals: increasing sleep surveillance.
- Behavioral Risk Factor Surveillance System (BRFSS) and selected findings were presented.Â The data is available for public access.
- Youth Risk Behavior Survey (YRBS) and selected findings were described. Links between sleep duration and risk-taking behaviors, obesity among high school students, daily physical activity and limited computer use were demonstrated. The data is available for public access.
- National Health and Nutrition Examination Survey (NHANES) and selected findings described. A subset of survey participants will be monitored by actigraphy for 7 days to independently assess sleep quality. The data is available for public access.
- The sleep research community is invited to make full use of the sleep data publicly available through the CDC. Data utilization is a consideration during the prioritization of future data collection by CDC.
- An existing “Sleep, Sleep Disorders, and Biological Rhythms” education module is due to be updated and the sleep research community invited to send comments. The sleep module is extensively utilized.
- Additional educational research avenues include the NIH FOA Education Research in Sleep Health and Sleep-Circadian Biology (R25).
- The AASM and SRS have launched a joint task force to discuss opportunities for the research community to facilitate the 2011 NIH Sleep Disorders Research Plan.
- The task force seeks to identify specific sleep and circadian research opportunities with potentially high impact on healthcare.
- Informing policy makers about the importance of circadian clocks and how that area relates to various diseases (diabetes, metabolism, mental health, etc.) may also be a useful activity.
- In order to advance this discussion, the task force anticipates a workshop will be organized to develop specific recommendations.
- An overview of NHLBI initiative and FOA development process was presented.
- The process originates with input from the stakeholder community through workshops, conferences, scientific publications, and public input.Â The input forms the basis of programmatic proposal further developed by program staff.
- Concepts emerging from NHLBI divisions are initially discussed internally (Idea Forum) for feedback and consensus building. Selected concepts go forward to a Board of External Experts where an estimate of relative significance and priority is developed. Concepts undergo a second level of external expert review by the NHLBI Advisory Council.Â Input from all levels of discussion are considered by the NHLBI Executive Staff along with programmatic and fiscal balance considerations in developing recommendations.Â Ultimately, decisions are finalized with approval of the NHLBI Director.
- A summary of DLD basic and clinical/translational research initiatives for FY07-12 was presented.
- Dr. Strollo (representing AASM) asked how the research community can be galvanized to address the most important research questions. Dr. Kiley said the output of the SRS/AASM Taskforce and other groups can come to SDRAB and NCSDR, and further suggested building on the existing foundations and what is already known in science and communicating the decisions.
- An outlined of what NHLBI expects from clinical trials was presented, including important question, robust trial design, careful oversight, dissemination of results, and impact on clinical practice. Other considerations may include clinical trials that are unlikely to be supported by industry, repurposing of drugs, and the evaluation of diagnostic/disease management strategies.
- Options for investigator initiated clinical trials were described including the R01 and R34.
- Institute-initiated clinical trials are relatively infrequent.
- The “network” organizational format may be considered when a large number of high impact questions derived from strong scientific foundation need to be rapidly tested, and to enable tight budgetary and administrative control over the process by NHLBI.
- Other factors include equipoise in the clinical care community over which questions are the most important, large and available patient population with equipoise for the trials, clinically-meaningful outcomes, high event rates for primary outcome, and a strong clinical trial research community leadership exists with a track record of successful and productive collaborations.
- Mr. Peter Mansbach spoke on behalf of the Circadian Sleep Disorders Network. An estimated half million Americans suffer from circadian sleep disorders. The societal impact and difficulty for those who are unable to follow a regular schedule due to circadian disorder was discussed.
- Status of the NCSDR website. Dr. Twery explained that a new NCSDR website was developed in 2010, but new NHLBI website procedures has delayed launch. The new website is expected to include new information, a fresh design, and will be 508 compliant.
- Dr. Bent described the purpose of health services research and its use by entities including government and employers to evaluate the quality of healthcare.
- Gaps in knowledge include decision-making, patient safety, effectiveness, efficiency, timeliness, patient-centered care, and equity in healthcare systems.
- Patient-centered outcomes may be most viable.
- Health Care Delivery research is supported by several agencies including the Veterans Administration, AHRQ, and the NIH (through CTSAs).
- The requirements for membership on panels operating under the Federal Advisory Committee Act were presented including the distribution of expertise, geographic representation, gender representation, and diversity considerations.
- All stakeholders and organizations are invited to submit potential candidates for Board nomination that encompass these required areas of consideration.
- Dissemination of the 2011 NIH Sleep Research Plan
- Editorial by Drs. Parthasarathy and Vitiello was published in the Journal of Clinical Sleep Medicine.
- A letter was published in the SRS Bulletin by NCSDR.
- Stakeholder and representatives were encouraged to consider additional communication channels for dissemination of the Sleep Research plan.
- Portfolio Analysis
- SDRAB members evaluated 692 current NIH sleep and circadian grants and mapped them across the 5 goals of the research plan. Results of this important baseline assessment were presented and discussed.
- The importance of coordination and consensus among researchers, professional societies, patient advocates, and other stakeholders over priorities was underscored.
- Finding biomarker(s) of sleepiness.
- Sleep apnea clinical trial with cardiovascular outcomes
- Board and audience invited to communicate needs to NCSDR.
- SDRAB discussed the strengths and weakness of relying on institute initiated programs. The board concluded that the primary focus should be on identifying high impact scientific questions demonstrating the importance of sleep to health and not wait for new FOAs.
- Chair thanked everyone for collaborative and congenial discussions, and adjourned the meeting.
- In-person SDRAB meeting will continue annually, and web/teleconference meetings may be scheduled between annual meetings. The exact date of the next meeting has yet to be determined (tentatively, late winter 2013). Â Details will be published in the Federal Register and communicated on the SleepRFA listserv.
These Minutes will be presented to the full Board at its next regularly-scheduled meeting for consideration, amended as approved, and formal adoption.
I hereby certify that the foregoing minutes are accurate and complete.
Sairam Parthasarathy, MD
Michael Twery, PhD
Last Updated October 2013