The 21st meeting of the Sleep Disorders Research Advisory Board (SDRAB) was convened at 8:45 on Tuesday, December 7, 2004, in Room D of the Natcher Conference Center on the National Institutes of Health (NIH) campus in Bethesda, MD. Dr. Stuart Quan presided as Chair.

TABLE OF CONTENTS

Attendees
Opening Comments
Report of the Director NCSDR
Center For Scientific Review(CSR)of Applications Relevant to Sleep-Dr. Michael Martin
State-of-the-Science Update on Restless Legs Syndrome-Dr. Christoppher Earley and Dr. Richard Allen
Education Activities
Public Reports
Other Business
Final Discussion
Adjournment
Certification

Sleep Disorders Research Advisory Board Page

BOARD MEMBERS PRESENT

Dr. Stuart F. Quan (Chair)
Dr. Sarah Caddick
Ms. Sheila Connolly
Dr. Kathryn Lee
Dr. Rafael Pelayo
Dr. Gina Poe
Dr. Susan Redline
Dr. Clifford Saper (via conference call)
Dr. Lorraine Wearley

BOARD MEMBERS ABSENT

Ms. M. Elizabeth Johns
Dr. Michael Sateia
Dr. Michael Smolensky

EX OFFICIO MEMBERS PRESENT

Dr. Carl E. Hunt, SDRAB Executive Secretary
Dr. Regina T. Dolan-Sewell
Dr. Merrill Mitler
Dr. Sam Speciale (for Dr. Andrew Monjan)
Dr. Marian Willinger

LIAISON MEMBERS PRESENT

Dr. Dan Chapman (by phone)
Dr. Harold Gordon
Dr. Nancy Pearson
Dr. Thomas Raslear
Dr. Roger Rosa
Dr. Bryan Vila

FEDERAL EMPLOYEES PRESENT

Mr. Al Golden, NHLBI
Ms. Sue Rogus, NHLBI
Ms. Susan Sagusti
Ms. Ellen Sommer, NHLBI

MEMBERS OF THE PUBLIC PRESENT

Mr. Robert Balkam, Restless Legs Syndrome Foundation
Ms. Georgi Bell, Restless Legs Syndrome Foundation
Mr. Jerome Barrett, American Academy of Sleep Medicine
Ms. Colleen Cancio, National Sleep Foundation
Mr. Darrell Drobnich, National Sleep Foundation
Mr. Steve Evangelista, SRI International
Dr. Neal Farber, Kleine-Levin Syndrome Foundation
Mr. Richard Gelula, National Sleep Foundation
Dr. Edward Grandi, American Sleep Apnea Association
Dr. Evaline Honig, Narcolepsy Network
Ms. Michelle Rodrigues, SRI International
Ms. Jessica Steinitz, National Sleep Foundation

INVITED GUESTS PRESENT

Dr. Richard Allen, Johns Hopkins University
Dr. Bruce Altevogt, Institute of Medicine
Dr. Christopher Earley, Johns Hopkins University
Dr. Michael Martin, Center for Scientific Review
Dr. Christine Melchior, Center for Scientific Review
Dr. Andrew Pope, Institute of Medicine (via phone)
Members, IOM Board on Neuroscience and Behavioral Health (via phone):
Kenneth B. Wells, MD, MPH (Chair)
Sid Gilman, MD (Vice-Chair)
Nancy E. Adler, PhD
William E. Bunney, MD
Karen Matthews, PhD
Emmanuel Mignot, MD, PhD
David Reiss, MD
Marleen Wong, LCSW
Charles F.Zorumski, PhD

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OPENING COMMENTS - Drs. Carl E. Hunt and Stuart Quan

Dr. Quan welcomed the participants. Dr. Hunt reviewed the NIH confidentiality/conflict of interest procedures for the Board members.

The Minutes from the June 23, 2004, SDRAB meeting were adopted unanimously

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REPORT OF THE DIRECTOR, NCSDR – Dr. Carl E. Hunt

Dr. Hunt welcomed the participants to the meeting, including those joining via the live web cast. He announced that two new Board members have been appointed: Ms. Elizabeth Johns, Executive Director of Apex, Inc. (a not-for-profit organization providing residential and vocational services to adults with disabilities), and a spokesperson for sleep apnea; and Dr. Michael Smolensky, Professor of Environmental Physiology at the University of Texas-Houston. In addition, Dr. Bryan Vila of the National Institute of Justice (NIJ), U.S. Department of Justice, has been appointed as a new Liaison Board member. New members of the Trans-NIH Sleep Research Coordinating Committee (SRCC) are Dr. Eleanor Hanna, NIH Office of Research on Women's Health (ORWH), and Dr. Ann O'Mara, National Cancer Institute; both are therefore also new Liaison Board members.

NIH 2005 Funding: Budgets for Fiscal Year (FY) 2005 are as follows:
- NIH: $28.37 billion (a 2.1 percent increase over FY 2004)
- Department of Health and Human Services (DHHS): $372.6 billion (a 4.2 percent increase).
- NIH sleep research: an estimated $208 million (a 2.4 percent increase from FY 2004).
- NIH Roadmap: $177 million, which may be supplemented by grants by individual Institutes and Centers (ICs). The Roadmap identifies major opportunities and gaps in medical research that no single IC can address.

Nature Insights Supplement on Sleep: Nature is a weekly scientific journal with 67,000 subscribers and a global audience of more than 500,000. Each month a Nature Insight supplement addressing a specific topic is included in one issue of Nature. A sleep-related Insight supplement to the October 2005 issue of Nature is being sponsored by the following Trans-NIH SRCC members: NHLBI, National Institute on Neurological Diseases and Stroke (NINDS), National Institute of Mental Health (NIMH), and ORWH. "Insight" is also printed as a separate supplement, and NCSDR will receive 1,500 copies at no additional cost.

National Sleep Conference: The National Sleep Conference-Frontiers of Knowledge in Sleep and Sleep Disorders: Opportunities for Improving Health and Quality of Life-was held March 29-30, 2004 (http://www.nhlbi.nih.gov/meetings/slp_front.htm). The opening remarks by Surgeon General Dr. Richard Carmona and the conference summary will be published in the January 15, 2005, issue of Journal of Clinical Sleep Medicine. After the conference, the American Heart Association announced that it would publish revised guidelines on chronic heart failure that will address sleep apnea and would commission an AHA Scientific Statement on Sleep Apnea and Cardiovascular Disease. A National Nursing Steering Committee was also formed after the meeting to address public sleep literacy recommendations.

Sleep Public Health Initiative: As recommended at the National Sleep Conference, NCSDR is beginning a planning process to develop a national sleep public health initiative. The first Planning Committee meeting will be held March 30, 2005, at the Natcher Conference Center. This meeting will include representatives from the Office of the Secretary, DHHS, the American Academy of Sleep Medicine (AASM), American Sleep Apnea Association (ASAA), American Thoracic Society, Narcolepsy Network (NN), National Sleep Foundation (NSF), Restless Legs Syndrome (RLS) Foundation, and the Sleep Research Society (SRS). Goals for this meeting include developing a partnership structure between Federal and private organizations, drafting a mission statement, identifying necessary resources, and developing an action plan. Additional stakeholders who need to be part of this collaborative public campaign will be invited to also collaborate. The Sleep Disorders Research Board will be an integral part of the development of this public sleep health initiative.

State of the Science Conference: The NIH Office of Medical Applications of Research (OMAR) is organizing an SOS Conference on Manifestations and Management of Chronic Insomnia in Adults on June 13-15, 2005, at the Natcher Conference Center. The Agency for Health Care Research and Quality (AHRQ) provides a systematic literature review for the conference through one of its Evidence-based Practice Centers

Institute of Medicine (IOM) Study Proposal : IOM will conduct a study entitled "Development of Strategies and Recommendations for Enhanced Support of Sleep Medicine and Sleep Research in Academic Health Centers." Total cost for the 18-month study is $810,000, with 55 percent from Federal funding (NIH Set-Aside Evaluation Program) and the balance from non-Federal sponsors: American Academy of Sleep Medicine, National Sleep Foundation, and the Sleep Research Society.

National Children's Study: The NICHD is sponsoring the National Children's Study, which will include 100,000 subjects (prenatal to age 21). The study will have five outcome themes/hypotheses: (1) undesirable outcomes of pregnancy, (2) altered neurobehavioral development, developmental disabilities, and psychiatric outcomes, (3) injury, (4) asthma, and (5) obesity and altered physical development. A consortium of more than 40 Federal agencies/departments, organizations, and support groups involved with child and environmental advocacy will participate. The study will be conducted at 88 study locations (counties and county aggregates based on a national probability sample). Eight vanguard locations are selected for the study's first stage. The first three data collection centers will be funded in 2005 and data collection will begin in 2006.

Report on Melatonin: The National Center for Complementary and Alternative Medicine (NCCAM) has commissioned the AHRQ to produce an Evidence Report on Melatonin for the Treatment of Sleep Disorders. This report will be released later in December, 2004.

Sleep Disorders Research Plan: The Plan is available on the NCSDR Web site at http://www.nhlbi.nih.gov/health/prof/sleep/res_plan/index.html Additional hard copies can be requested from NCSDR.

National Health and Nutrition Examination Survey (NHANES) The 2005-2006 Household Questionnaire will include 23 questions related to sleep duration, sleep problems, and sleep disorders. Data collection will take place in 2005-2007.

National Institute of Justice (NIJ): Dr. Vila reported that the NIJ is now funding three research studies on sleep disorders related to police officers: (1) A study of police officers in Buffalo, NY, co-funded by NIJ and the National Institute for Occupational Safety and Health, that examines morbidity and mortality among police officers and includes biomarkers and physiologic measures related to fatigue and sleep disorders; (2) Sleep-related measures in an NIMH study assessing risk and resilience factors in police recruits who are followed for 2 years; and (3) A Harvard Medical School and Brigham and Women's Hospital study of fatigue countermeasures and sleep disorders among 1,000 police officers in Boston.

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CENTER FOR SCIENTIFIC REVIEW (CSR) OF APPLICATIONS RELEVANT TO SLEEP-Dr. Michael Martin

Reorganization of Study Sections. In 1992, it was mandated that applications to the Alcohol, Drug Abuse, and Mental Health Administration be integrated with applications to NIH. This led to the formation of 21 new neuroscience study sections in three Initial Review Groups (IRGs) starting in June 1998, and the formation of 19 new behavioral study sections in three IRGs starting in June 1999. The balance of the study sections in CSR were re-organized in three phases over the past 7 years. Phase I of the redesign of IRGs was completed when a special Panel on Scientific Boundaries of Review [PSBR] submitted its recommendations in 2000; 24 IRGs were proposed, based primarily on organ systems and diseases. Phase II was the design of study sections by working groups with academic members (2001-2003). Phase III was the implementation of integrated study groups (2003-2005).

Continuous Assessment. IRG Working Groups made up of non-Federal research experts were established to evaluate the IRGs every 4-6 years on the scientific boundaries of the study sections; the scope and breadth of the science reviewed; accommodation and new directions and emerging areas; appropriateness, qualifications, and stature of reviewers; and fairness of reviews for all grant mechanisms. Additional feedback has included a Reviewers Satisfaction Survey and a survey of applicants affected by the neurosciences reorganization(completed); a survey of applicants affected by the behavioral sciences reorganization has been approved and will take place in the near future. The June 2000 customer satisfaction survey found general satisfaction. The Neuroscience Survey found that applicant satisfaction is strongly correlated with funding; no areas were identified where applicants or program staff was mostly dissatisfied. Ratings were generally a bit lower for reviewer comments and for review of new investigator applications.

Monitoring Clinical Research. A Special Assistant on Clinical Research Review, Dr. Ted Kotchen, was appointed in 2002. He has conducted several assessments on the fate of clinical research applications reviewed by CSR. In his analysis of the period 1996 to 2001, he found no differences in review outcomes between physicians and non-physicians. Outcomes were least favorable for clinical applications, especially for those with human subjects concerns. The CSR has also moved to clustering human subject's research applications to assure appropriate expertise and perspective. Dr. Kotchen is currently analyzing the voting behavior among clinical/nonclinical reviewers.

Discussion. Currently, 50 percent of all people on study sections are ad hoc invited reviewers, but many of these are repeaters. Discussants made the following suggestions:
- Include 1-2 sleep experts on the six study sections that get sleep applications.
- Provide appropriate reviewers. Cluster human services research.
- NIH should review new applicants within the context of their career; those with competitive renewals have been through the process.
- Because one expert's opinion may dominate on some panels, the study section chair needs to ensure that all applications get a full discussion.

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STATE-OF-THE-SCIENCE UPDATE ON RESTLESS LEGS SYNDROME-Dr. Christopher Earley and Dr. Richard Allen

RLS is a disorder of sensation with associated motor component; it involves circadian rhythms and occurs mostly at night. One hypothesis is that RLS represents a deficiency of iron in the brain. RLS patients with normal body levels of iron have low levels of ferritin in some brain regions. Magnetic resonance imaging (MRI) demonstrates low iron concentration in the substantia nigra. Neurons from brain cells in this region show an absence of iron staining in cells from RLS patients compared with controls. Additional evidence for brain iron deficiency in RLS comes from animal models of brain iron deficiency. Brain iron deficiency may also alter brain systems other than the substantia nigra-e.g., by affecting the diencephalo-spinal dopamine system and levels of hypocretin/orexin, histamine, and serotonin.

Another hypothesis is that RLS represents a hypoactive dopamine system. This is based on the fact that dopamine agonists will work most of the time to treat RLS symptoms. However, data were present that suggests that RLS may be a hyperarousal state with increased dopamine synthesis. The final pathway leading to RLS may be a change in the iron-dopamine system.

Recent epidemiologic studies include new data from telephone diagnostic interviews, diagnostic questionnaires, and severity assessment (using scales and frequency/level of distress). Five population-based surveys (in Germany, the European Union (EU) and United States, Sweden, Turkey, and Singapore) have examined the prevalence of RLS. The REST study in the five Western European countries and the United States reported an overall frequency of 7.2%. More than 2 episodes per week with distressing symptoms occurred in 1.7% of men and 3.7% of women.

Increased prevalence of RLS has been found in Western European populations with a prevalence of 7-11% in Western populations, compared with 3 percent in Turkey, less than 3% in Asian populations, and 1% in African Americans. RLS may be caused by a recessive gene related to iron deficiency. The relative risk is greater in women compared with men, with the highest risk in women up to age 65 who have had 3 or more children, and in blood donors. In Sweden, the relative risk is 2.3 times greater among persons who regularly donate blood, which they can do 2-6 times per year.

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EDUCATION ACTIVITIES - Ms. Sue Rogus, Ms. Ellen Sommer

Ms. Rogus reviewed recent sleep education activities:

- The high school science curriculum supplement, "Sleep, Sleep Disorders, and Biological Rhythms," was recently released and is available free either in print or online. Approximately 12,000 copies were sent to teachers. There have been more than 11,000 visitors to the sleep curriculum Web site and 10,000 down-loads. More than 2,000 students have entered sleep diary data on the Internet.

- The "Healthy Sleep Handbook," a booklet for the general public, is in preparation. This publication will provide an overview of sleep disorders with signs/symptoms, consequences, and treatment. It will explain why sleep is needed, what happens if you don't get enough sleep, and tips on how to obtain enough sleep. The adverse outcomes of sleep deprivation (e.g., drowsy driving) will be covered in the section on adolescents. The handbook follows the format of the NHLBI's "Healthy Heart Handbook for Women" and will have more than 60 pages. The Handbook will be published in mid-2005.

- Outreach to Latinos includes participation at the National Promotoras Conferences held in April and August 2004 to get input from this group of lay health educators. Promotoras view sleep disorders as a major issue and would like publications that are bilingual and culturally relevant. We are obtaining additional input from the Promotoras in our planning of a family-targeted, bilingual publication on sleep. We are also considering adapting the Garfield Fun Pad for Latino audiences.

- NHLBI's Diseases and Conditions Index (DCI) includes Web-based fact sheets that can be easily updated. A new fact sheet on sleep apnea has recently been completed, one on RLS is under review, and one on narcolepsy is in preparation. Future DCI titles will include problem sleepiness and insomnia. "Just in Time" printing allows the NHLBI Information Center to print the DCI fact sheets on an as-needed basis.

- The Garfield Star Sleeper Campaign will continue for another 5 years, under a renewed agreement with the Garfield creator.

Ms. Sommer reported on the Time for Kids (TFK) project. TFK is a Time Inc. subsidiary that distributes in-school materials for teachers and students. A sleep-related issue of Time for Kids was distributed to 30,000 third grade teachers and the 750,000 children in their classes last March at the beginning of National Sleep Awareness Week 2004. This distribution included a "Be a Star Sleeper" magazine for third-graders and a Teacher's Guide. To evaluate the project, an e-mail survey of 50 teachers nationwide was conducted in June. Ninety percent of the teachers said they used the materials in the classroom; 90 percent said the students liked the materials, and 80 percent said they were very satisfied with the Teacher's Guide. Following minor revisions, these same TFK materials will again be distributed to third-grade students and teachers at the beginning of National Sleep Awareness Week the last week in March, 2005.

Board members encouraged long-term assessment of sleep knowledge and sleep behavior extending into junior high school and beyond. In addition, feedback on the high school biology curriculum will help develop partnerships in the community between schools and sleep specialists.

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PUBLIC REPORTS

Dr. Neal Farber, Co-President, Kleine-Levin Syndrome (KLS) Foundation

Dr. Farber presented an overview of KLS, an unusual sleep disorder affecting young adults and adolescents. Affected patients have cyclic periods in which they sleep 20-22 hours per day and show other behavior and cognitive disorders, but are normal between episodes. Greater awareness of this under-diagnosed disorder is needed.

The KLS Foundation maintains a Web site and chat room and has a Medical Advisory Board. It is supporting a study of human leukocyte antigen (HLA) and other genetic factors potentially predisposing to KLS. This study will be conducted by Dr. Emmanuel Minot at Stanford University as part of a larger study of HLA-predisposing genes in disorders of excessive daytime sleepiness. The study will include a questionnaire to collect information on genetics, KLS episodes, and other sleep-related diseases. Information about the study can be obtained from Dr. Minot or Dr. Isabelle Arnulf at arnulf@standford.edu.

Mr. Jerome Barrett, Executive Director, American Academy of Sleep Medicine

Mr. Barrett reported on several new AASM initiatives:

- AASM will launch the Journal of Clinical Sleep Medicine on January 15, 2005. Dr. Quan is the editor. This new journal will be published four times per year and sent to subscribers of Sleep. Manuscripts can now be submitted online.

- The Board of Directors of the Accreditation Council for Graduate Medical Education (ACGME) has approved the program requirements for subspecialty education in sleep medicine training that were proposed by the AASM. The AASM and ACGME will host a joint education session for program directors in early 2005.

- AASM and Pfizer announced the following grants: the AASM/Pfizer Visiting Professorships in Sleep Medicine (for lectures) and the AASM/Pfizer Scholars Grants in Sleep Medicine (to support career development).

- AASM conducted a survey of all sleep centers (both accredited and non-accredited) in four States. An updated paper about the number of sleep evaluations conducted each year in sleep laboratories will be published in the Journal of Clinical Sleep Medicine in March, 2005 (updating a 2000 paper).

-AASM has launched a public education initiative in collaboration with Stewart Communications, Ltd. An 18-month education campaign will be introduced after National Sleep Awareness Week.

Dr. Evaline Honig, Executive Director, Narcolepsy Network (NN)

Dr. Honig, the new director of the NN, reported that the Network's goals include raising awareness, funds, and membership. The NN presently has four major activities: supporting people with narcolepsy and their families and friends; educating people with narcolepsy about medical and social assistance; work with care providers and community members to improve awareness, diagnosis, and treatment; and supporting research to improve social services, information availability, and medical treatment. The 19th annual NN conference was held in October 22-24, 2004 in Seattle. Also in 2004, NN developed a Sleep Disorders Screening Program for high-traffic areas like shopping malls and health fairs. Future activities include a Sleep Disorder Screening Program planned for April 2005, and efforts to increase public awareness by establishing contacts with the National School Nurse Association and pediatric organizations. Several brochures and a professional member packet that includes a patient kit are under development. Dr. Honig noted that the NN national office is now located in Rhode Island and New York.

Dr. Edward Grandi, Executive Director, American Sleep Apnea Association

AASA has published a fall edition of its newsletter, WAKE-UP CALL, and a Spanish-language version of its Get Facts About Sleep Apnea brochure. It is collaborating with the NSF on Sleep Apnea Awareness Day, to be held Thursday March 31, 2005, during National Sleep Awareness Week. AASA will sponsor a lecture on the State-of-the Science on Sleep Apnea in Washington, DC in 2005.

Mr. Richard Gelula, Chief Executive Officer, National Sleep Foundation (NSF)

The focus of the NSF is on disseminating what is known about sleep problems and sleep disorders to the public. Related activities include public relations, public awareness, and the formation of coalitions/collaborations. NSF's Web site (www.sleepfoundation.org) has seen a 42 percent increase in traffic in the last year, with 150,000 visits per month. He made the following additional comments:

- National Sleep Awareness Week (March 28-April 3, 2005) is pegged to the start of Daylight Savings Time. (We can't afford to lose an hour of sleep.)

- Sleep disorders is the focus of the 2005 Sleep in America Poll. The telephone poll, which includes questions on body mass index and signs and symptoms of sleep disorders, will be administered to 1,500 respondents.

- Publications include NSF Alert (a weekly e-mail) and Sleep Matters. The current issue of Sleep Matters focuses on sleep and pregnancy.

- Toolkits on sleep apnea are being developed to target motor carriers, workplaces, and schools.

Ms. Georgi Bell, Executive Director, Restless Legs Syndrome (RLS) Foundation

Ms. Bell reported that "An Algorithm for the Management of Restless Legs Syndrome," was authored by several members of the RLS Medical Advisory Board and published in the July 2004 issue of Mayo Clinic Proceedings. A new publication, Scientific Bulletin, will be sent quarterly to health care providers.

Ms. Bell noted that the autopsy results from the studies reported by Drs. Earley and Allen were from the RLS Foundation's brain collection at the Harvard Brain Tissue Resource Center.

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OTHER BUSINESS

Institute of Medicine (IOM) Study: Development Of Strategies And Recommendations For Enhanced Support Of Sleep Medicine And Sleep Research In Academic Health Centers-IOM/SDRAB Conference Call:

Dr. Hunt welcomed Dr. Andrew Pope, Director of the IOM Board on Neuroscience and Behavioral Health and several Board members (see "Invited Guests Present"). They joined the meeting by conference call to provide an update on the status of planning for the IOM study entitled "Sleep Medicine and Sleep Research" (also see Director's Report). Dr. Pope reported that IOM will convene an ad hoc panel of experts in public health, academic and medical administration, and health sciences research to identify (1) the public health significance of sleep, sleep loss, and sleep disorders, (2) barriers and opportunities for improving interdisciplinary research and medical education and training in the are of sleep and sleep medicine, and (3) strategies for developing increased support for sleep medicine and sleep research in academic health centers. The Panel will be appointed soon. The study results will be published by June, 2006.

During the discussion, the following points were raised:

- Sleep disorders in early childhood and developmental psychopathology should be included as part of the review of sleep-related knowledge. For example, a University of Michigan study found a high correlation between schoolyard bullies and obstructive sleep apnea.

- A wide range of specialties, including pediatrics, will need to be represented on the committee.

- SDRAB members should be on the IOM distribution list for scheduled activities related to ongoing conduct of this study. A representative from the SDRAB should attend the Panel meeting in March in order to provide sleep-related input to the Panel and in order to keep the SDRAB fully informed as the study progresses.

- The Department of Veterans Affairs (VA) director of research should be made aware of the study because the VA deals with issues such as trauma, PTSD, and sleep disorders. Names of contacts at the VA should be forwarded to Dr. Pope.

Sleep Literacy: Public Health Initiative-Dr. Carl E. Hunt

Dr. Hunt opened a discussion about how to proceed with the Sleep Literacy Public Health Initiative that was discussed during the morning session. Two examples to build on are the CDC's Colorectal Cancer Roundtable and the National Viral Hepatitis Roundtable (in conjunction with Hepatitis Foundation International). The roundtables include public and private organizations that have an interest in these topics. Another model is NHLBI's Red Dress Campaign, which brings attention to the issue of heart disease in women. Dr. Hunt asked for comments or suggestions about how we can develop a similarly effective campaign for sleep disorders.

The Board will appoint two SDRAB members -one representing the science community and one representing the public-to participate in the March 30, 2005 meeting to begin planning a Sleep Literacy Public Health Initiative. Dr. Lorraine Wearley was appointed as the public representative and Dr. Gina Poe as the scientific representative.

Insomnia State-of-the-Science Conference-Dr. Regina Dolan-Sewell

Dr. Dolan-Sewell provided an update on the SOS Conference on Chronic Insomnia that will be held June 13-15, 2005 at the Natcher Conference Center. The focus of the conference will be the manifestations and management of chronic insomnia, including defining areas of need for future research.

The conference will address the following five questions:

- How is chronic insomnia defined, diagnosed, and classified, and what is known about its etiology?

- What are the prevalence, natural history, incidence, and risk factors for insomnia?

- What are the consequences, morbidities, comorbidities, and public health burden associated with chronic insomnia?

- What treatments, alone or in combination, are used for the management of chronic insomnia, and what is the evidence regarding their safety, efficacy, and effectiveness?

- What are important future directions for insomnia-related research?

The NIMH is the lead sponsor of the SOS conference, and the National Center on Sleep Disorders Research (NCSDR) has also been an active participant in the planning process. The co-sponsors include NCSDR (NHLBI), NCCAM, NIAAA, NINDS, ORWH, NIDA, NIA, and NINR. Other Federal cosponsors include the VA, Department of Transportation, and AHRQ. The SOS Consensus Panel Chair is Dr. Alan Leshner, CEO, American Association for the Advancement of Science, and Executive Editor of Science.

Programmatic Assignment of Sleep Applications-Dr. Nancy Pearson

Dr. Pearson summarized an analysis of the NIH application database for applications related to sleep. They looked at FY 2004 applications across all ICs by searching the NIH application database for the words "sleep" or "circadian" in the title or abstract. The results were tabulated both by primary and secondary IC assignment. A total of 2,144 applications were found. Sleep and circadian applications are found across all ICs; the ICs with the greatest number of applications (100 or more) were NIMH, NHLBI, NINDS, NIA, NICHD, and NIDA. Fifty-four percent of the applications were assigned to a single IC, and 46 percent had a secondary assignment. Dr. Pearson noted that if a topic is relevant to several Institutes, there are more potential opportunities for funding. In the cover letter, applicants can request multiple IC assignments.

During the discussion the following points were made:

- The 2,000+ applications were reviewed by more than 50 study sections.

- Discussants noted that the type of grant applied for may determine whether the review is done by an IC study section (Special Emphasis Panel) or the CSR. In 2003, 65 percent of grants to NIH were reviewed by the CSR.

Sleep Heart Health Study Data Sharing Survey-Dr. Susan Redline

The Sleep Heart Health Study Data Sharing Survey is being developed by the Sleep Reading Center at Case Western Reserve University to help investigators access sleep study data and associated clinical data and enhance opportunities for collaborative research. An online survey can be found at http://shhs1.case.edu/pages/survey.php. A Web site being developed will include polysomnography data from 1,000 patients that is being made available to other researchers.

The sleep survey is part of the NHLBI's Sleep Heart Health Study (SHHS), a multi-center cohort study to determine cardiovascular and other consequences of disordered breathing. Information about the SHHS can be found at http://www.jhucct.com/shhs/. There are more than 6,000 participants in the SHHS from eight existing cohort studies including the Cardiovascular Health Study and the Framingham Heart Study. These cohorts span more than three decades and include longitudinal data on cardiovascular disease (CVD), hypertension, and lung disease. The data being collected by the SHHS will include covariates for CVD, lipids, and peripheral arterial disease.

Efforts are being explored to distribute information about this new research resource to the widest possible audience of researchers who could potentially access this rich data base and enhance opportunities for new research collaborations. A secondary goal of this effort is to collect a comprehensive database that will define optimal ways to measure sleep apnea.

FINAL DISCUSSION-Dr. Stuart F. Quan and Board

Research Plan. The Board needs to periodically review the prioritized research recommendations in the context of new developments and new research results. Also, we need to continue disseminating information about the Plan to potential new investigators in order to stimulate more investigator-initiated applications.

Comments from discussants:

- Review the Research Plan at each Board meeting and provide updates to encourage initiatives.

- Track responses following release of the Plan, keeping in mind that 1 year may not be enough time to see response.

- Review recent conferences/workshop recommendations to periodically update the prioritization of the research recommendations in the Plan.

- Review the Research Plan now in the context of what should have the highest priorities in 2005 for new initiatives.

- Where sleep is relevant, broaden RFP/RFAs on other diseases to include sleep.

- Form a subcommittee to consider the Research Plan and address it from the perspective of these comments. Dr. Quan will appoint this subcommittee and the NCSDR will provide logistical support. This subcommittee will report at the June 9th Board meeting.

Dr. Hunt closed the meeting by presenting a Garfield doll to members of the full Board that have not yet received one. Garfield is our "spokescat" for healthy sleep and the dolls are an excellent first step in engaging the attention of potential stakeholders who can assist in enhancing public sleep literacy.

Upcoming Meetings. The revised dates for the next meetings of the SDRAB are June 9, 2005, December 6, 2005, and June 14, 2006.

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ADJOURNMENT

Dr. Quan thanked the participants and adjourned the meeting at 3:00 p.m. EDT.

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CERTIFICATION

We certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.

Stuart Quan M.D., Chair
Sleep Disorders Research Advisory Board

Carl E. Hunt, M.D., Executive Secretary
Sleep Disorders Research Advisory Board

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