The 22nd meeting of the Sleep Disorders Research Advisory Board (SDRAB) was convened at 8:45 a.m. on Thursday, June 9, 2005, 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
Tools And Approaches For Managing Fatigue In Transportation- Drs. Michael Coplen And Stephen Popkin
Sleep-Wake Circadian Rhythm: Illness And Light-Dr. Michael H. Smolensky
Education Activities
Public Reports
The Role For Epidemiological Studies In Furthering Our Understanding Of Sleep And Health-Dr. Susan Redline
Update: Institute Of Medicine Study-Dr. Bruce Altevogt
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
Ms. M. Elizabeth Johns
Dr. Kathryn Lee
Dr. Rafael Pelayo
Dr. Gina Poe
Dr. Susan Redline
Dr. Michael Sateia
Dr. Michael Smolensky
Dr. Lorraine Wearley

BOARD MEMBERS ABSENT

Dr. Clifford Saper

EX OFFICIO MEMBERS PRESENT

Dr. Thomas Balkin
Dr. Regina T. Dolan-Sewell
Dr. Robert Greene
Dr. Carl E. Hunt, SDRAB Executive Secretary
Dr. Merrill Mitler
Dr. Andrew Monjan
Dr. Elizabeth Nabel

LIAISON MEMBERS PRESENT

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

FEDERAL EMPLOYEES PRESENT

Mr. Al Golden, NHLBI
Ms. Ellen Sommer, NHLBI
Dr. Sam Speciale, National Institute on Aging (alternate SRCC member from NIA)

MEMBERS OF THE PUBLIC PRESENT

Mr. Jerome Barrett, American Academy of Sleep Medicine
Mr. Robert Balkam, Restless Legs Syndrome Foundation
Ms. Georgi Bell, Restless Legs Syndrome Foundation
Mr. Darrell Drobnich, National Sleep Foundation
Dr. Neal Farber, Kleine-Levin Syndrome Foundation
Dr. Edward Grandi, American Sleep Apnea Association
Dr. Maureen Hannley, American Academy of Otolaryngology and Head and Neck Surgery
Dr. Eveline Honig, Narcolepsy Network

INVITED GUESTS PRESENT

Dr. Bruce Altevogt, Institute of Medicine
Dr. Michael Coplen, Department of Transportation
Dr. Stephen Popkin, Department of Transportation

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

Dr. Hunt welcomed the Board members and other participants, including Dr. Dan Chapman, a liaison member attending via phone. Dr. Quan also welcomed the participants and asked the Board members to introduce themselves. He called attention to the NIH confidentiality/conflict of interest forms for the Board members, and asked them to notify him if they have changes to make in the forms.

The Minutes from the December 7, 2004, SDRAB meeting were adopted unanimously.

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

Dr. Hunt called attention to the 2004 Annual Report of the Trans-NIH Sleep Research Coordinating Committee (SRCC) that was in the meeting binder and is also available on the NCSDR Web site. The report summarizes FY 2004 programs and sleep-related research for the 12 NIH Institute and Center members.

Dr. Hunt welcomed three new members attending their first SDRAB meeting. Dr. Michael Smolensky, Professor of Environmental Physiology at the University of Texas-Houston, is one of the Board's eight science members. Ms. M. Elizabeth Johns, Executive Director, Apex, Inc., a patient advocate representative specializing in sleep apnea, is one of the SDRAB's four public members. Dr. Thomas Balkin, Chief of the Department of Behavioral Biology, Walter Reed Army Institute of Research, is a new ex-officio member, representing the Department of Defense.

Dr. Hunt provided updates on the following topics:

Funding for Sleep Research. Funding levels from 1996 to 2005 (including final data for FY 2004 and estimates for FY 2005) show overall encouraging growth in sleep research (from $76,143,000 in 1996 to $196,239,000 in 2004). In 2004, funding was about $1 million less than in FY 2003 (the first such dip), but the 2005 estimate is $200,810,000. For the years 1996 to 2004, funding increased 130 percent for NIH overall whereas funding for sleep research overall increased 158%. Within NHLBI during this same time period, sleep research increased 200 percent for NHLBI. New strategies and approaches may be needed to ensure continuing growth in funding for sleep research so as to further advance biomedical knowledge related to sleep and sleep disorders.

State-of-the-Science (SOS) Conference. The NIH Office of Medical Applications of Research (OMAR) will hold its SOS Conference on Manifestations and Management of Chronic Insomnia in Adults on June 13-15, 2005, at the Natcher Conference Center. An independent Consensus Panel will address five questions related to this topic and prepare a final consensus Statement.

Institute of Medicine (IOM) Project. The IOM study entitled "Development of Strategies and Recommendations for Enhanced Support of Sleep Medicine and Sleep Research in Academic Health Centers" will be discussed later in the meeting by Dr. Bruce Altevogt. IOM held its first public meeting on this topic in April 11-12, 2005, and will hold its second public meeting on June 29-30.

NCSDR Workshops. A workshop on Neuroimaging in Sleep Deprivation and Sleep Disorders will be held March 29-30, 2006. Co-chairs are Drs. Allan Pack and John Mazziotta. The workshop will focus on questions that can be answered with neuroimaging as well as opportunities presented by this rapidly moving technology. Workshop sponsors include NHLBI, NINDS, NIMH, NIA, NIDA, NIAAA, and NICHD.

Nature "Insight" Supplement on Sleep. Sleep will be the topic of the "Insight" supplement included as part of the October 20, 2005 issue of the journal Nature. Nature will also reprint the Insight as a separate print publication. NIH sponsors of this project include NHLBI, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, and the Office of Research on Women's Health. Five sleep-related articles for this "Insight" issue are under review.

Research Plan. We are continuing to widely distribute the 2003 National Sleep Disorders Research Plan. The SDRAB recently developed and prioritized 10 recommendations. The ongoing perspective of Board members regarding priorities and areas of emphasis will be addressed during a discussion later in the meeting. High School Biology Curriculum. The high school biology curriculum was released in 2004; 13,000 copies were sent to high school science teachers, and an additional 17,000 copies are available. The curriculum includes five standard lessons preceded by a 10-day sleep diary. SDRAB input is requested to determine how to enhance distribution, maximize implementation, and develop outcome evaluation strategies.

Database Analysis. NCSDR has recently contracted to identify existing databases with data pertaining to sleep and sleep disorders that can be consolidated and then accessed electronically by sleep researchers. Selected resources will be annotated with regard to data accessibility, cohort size, and summary tabulations. A report will be compiled and formatted for dissemination via HTML and PDF formats. The final report is expected to be completed before the next Board meeting on December 6, 2005.

Vision for the Future. Later in the meeting, NHLBI Director Dr. Nabel will discuss with SDRAB members a vision for the future of sleep research. She attended, and made a presentation at, the American Thoracic Society meeting last month and will make a presentation at the Associated Professional Sleep Societies (APSS) meeting in Denver on June 20, 2005 focusing on the vision for NHLBI in general, and sleep in particular. Dr. Quan's phone interview with Dr. Nabel was published in the Journal of Clinical Sleep Medicine (Vol. 1, No. 2, 2005), and an editorial by Dr. Nabel will be published in a forthcoming issue of Sleep.

Discussion. Participants made the following suggestion during the discussion:

- The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) should be considered for inclusion in the Trans-NIH SRCC because recent evidence suggests diabetes and some metabolic disorders are related to sleep deprivation and, in some cases, sleep disorders. Dr. Hunt indicated that a dialogue with NIDDK leadership had been initiated to explore potential interest in joining the SRCC. We are presently collaborating with NIDDK regarding an intramural project on short sleep durations in obese subjects and an extramural multi-center bariatric surgery study.

- Efforts are needed to determine how to encourage enhancement of sleep-related research related to aging. It was noted that NIH sleep research funding reported for FY 2004 by the National Institute on Aging decreased from the prior year.

- ALZFORUM.NET was suggested as a possible database resource for inclusion in the list of sleep-relevant databases that is being prepared. Members should provide information to Al Golden or Dr. Hunt about other pertinent databases.

- The NIH Roadmap initiatives should be particularly relevant to sleep research given their highly interdisciplinary focus. The sleep research community, however, is still an emerging field in comparison to other, more established areas of research (e.g. cancer, infectious diseases, heart disease)

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TOOLS AND APPROACHES FOR MANAGING FATIGUE IN TRANSPORTATION- Drs. Michael Coplen And Stephen Popkin

Dr. Thomas Raslear of the Department of Transportation (DOT) introduced his colleagues who will provide an overview of fatigue-related problems in the transit industry and DOT's efforts to address these problems.

Current Approaches and Limits. Dr. Popkin noted that fatigue is common among U.S. transportation operators who work long hours, rotate from day to night schedules, and have significant mental/physical stress, varying workloads, and irregular work/rest patterns. Fatigue is also a problem among shift workers in other occupations in three sectors-operational (e.g., banking, construction), service (e.g., hospitals, air control), and process (e.g., chemicals, industry). Death rates and injuries are three times higher among workers on night shifts compared with those on day shifts.

In 1990, the National Traffic Safety Board (NTSB) asked DOT to develop a fatigue research program, provide education to workers and companies, and revise hours-of-service regulations based on science. Some problems are the lack of a mature technology to determine fatigue onset, difficulty in accurately detecting evidence of fatigue after accidents, and resistance to changes in hours of service and laws/regulations from both management and workers.

The current European approach is very prescriptive (i.e., using regulations to change hours and services). The current U.S. approach is prescriptive but is hampered by legal issues and low tolerance for change on the part of businesses. Australia uses a nonprescriptive approach, with fatigue viewed like any other hazard and regulators responsible for enforcing the process. The United States lacks an infrastructure for a nonprescriptive approach, uniform education and training programs, and training and evaluation standards for work schedule managers.

DOT has a new research focus on nonprescriptive approaches to fatigue management. The Human Factors Coordinating Committee offers three resources: the Fatigue Management Reference Guide provides best practices; a Fatigue Issues and Policy Framework identifies needs, prioritizes fatigue research, and presents a strategic plan; and the XIMES software tool allows comparison of schedules. Business case tools and a methodology to validate fatigue models are being prepared. Industry support comes from consultancies, working groups, foundations and advocacy groups, in-house fatigue managers, and university programs.

Accreditation and Certification Approaches and Optional Models. Dr. Coplen described efforts to address the lack of trained work scheduling professionals. Starting in 1986, the DOT developed an advanced knowledge specification and certification process. The first step was to determine knowledge, skills, and abilities needed for job analysis and develop curriculum content and education requirements. Potential curriculum competency areas are sleep, chronology, coping strategies, organization aspects of shift work and risk mitigation, and ergonomic work schedules and staffing analysis, and implementation issues.

In 2004, a Government Steering Committee was established to develop procedures for establishing a curriculum and credentials for work schedule managers. The Steering Committee will seek collaborative funding to initiate a program, develop a long-term plan and briefing papers, and get buy-in from Government researchers/academia/industries and trade associations. The next steps will be to conduct job analyses across the three sectors; identify managers in the field to get their input; and conduct interviews with experts from government, academia, and industry. Other goals are to create an organizational development plan, draft a technology transfer plan, and determine long-term funding needs.

Dr. Coplen asked the SDRAB to identify opportunities and roadblocks for the credentialing approach and opportunities for improvement. He suggested that the SDRAB could participate in the Government Steering Committee and help reach out to the sleep research community as a resource and advocate. The following comments were made during the discussion:

- Consider asking insurance companies to join the Steering Committee as they are a potentially important stakeholder group. (In Australia, insurance companies take routes and work time into account.) The Environmental Protection Agency could help get business on board.

- Encourage cost accounting of fatigue-related mishaps. Lack of data is a problem.

- Identify organizations that went through similar processes and have successful models. Involve schools of public health and the National Institute of Occupational Safety and Health in the effort.

- Encourage workers to self-identify hazardous fatigue-related conditions. A train-the-trainer program is one approach. The Federal Aviation Administration and the medical community have systems for self-identification, and some companies have internal policies in place to encourage self-identification.

- Reach the sleep community through national recognition and payment for research, talks, and publications. Solicit suggestions for research.

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SLEEP-WAKE CIRCADIAN RHYTHM: ILLNESS AND LIGHT-Dr. Michael H. Smolensky

Dr. Smolensky noted that the human time structure encompasses short, medium and long period rhythms. Circadian rhythms have been most studied and most known. They are generated by an inherited master biological clock, the paired suprachiasmatic nuclei, situated in the hypothalamus. The inherited period of the circadian clock in most persons is not exactly 24.0 hours, but slightly shorter or longer than this. The ambient light/dark cycle helps adjust this clock in period and phasing, from one day to the next, so it is in tune with both the societal and ambient 24-hour day. Environmental light-dark time cues are conveyed to the biological clock via the retinal hypothalamic neural tract. Light can advance (if exposure occurs very early in the morning) or delay (if exposure occurs very late at night) the circadian cycle; thus, medical conditions that disrupt nighttime sleep might have the potential to alter the circadian time structure in the presence of nocturnal ambient light signals. Thus, nighttime sleep disruption is not only a potential cause of sleep deprivation but also altered biological efficiency due to disturbed circadian rhythms and time structure.

- Common medical conditions that worsen at night and disrupt sleep include allergic rhinitis, asthma, peptic ulcers/GERD, acute urticaria/allergic dermatitis; gout/gallbladder disease, nocturia/enuresis, and the pain of occupational injury, migraine, rheumatoid and osteoarthritis and toothache.

- Other potential medical and public health consequences of sleep deprivation and disturbed sleep/wake rhythm include decreased mental performance, daytime fatigue, heightened risk of driving and other types of accidents, melancholy mood, endocrine alterations, nocturnal hypertension (which can lead to diseases of the kidney, eye, brain, heart, and circulatory system), poor response to cancer chemotherapy and elevated risk of breast and colorectal cancer in women who chronically work night shifts.

- Occupational light exposure and certain medications, depending on dosing times, may exert acute and chronic impact on the sleep-wake rhythm and result in disordered and compromised sleep.

- Under appreciated causes of disordered sleep include evening/nighttime occupational exposure to bright light, late-night computer use, and bedtime medication ingestion, such as, beta-blockers, synthetic corticosteroids and SSRIs which tend to have more side effects when taken in the afternoon or later in the day.

Dr. Smolensky said that further research is needed to better understand (1) the association between sleep deprivation, in general, and nocturnal hypertension as a causal factor of end-organ damage and injury, including cardiovascular disease, (2) the impact of sleep disruption on the endocrine system (e.g., melatonin, growth hormone, etc production) and its consequences and (3) the effect of medications, such as beta-agonists, synthetic corticosteroids, SSRIs and others on sleep and the sleep-wake cycle, itself. He concluded that the medical community must be made aware that a variety of common medical conditions worsen at night and disrupt sleep, resulting in nighttime awakenings/insomnia.

During the discussion, it was noted that while light exposure in the circadian phase can lead to a variety of consequences; it is difficult to interpret these in individual patients. Also, while light pollution can be a serious and unrecognized problem, timed bright light therapy can be helpful to some medical conditions, such as depression. Board members agreed that clinical study of the adverse effects of sleep disruption secondary to common chronic medical conditions is needed, taking into consideration the changing demographics of the U.S. population and the increasing incidence of chronic medical conditions with aging that have the potential to disrupt nighttime sleep.

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EDUCATION ACTIVITIES - Ms. Ellen Sommer

Ms. Sommer, on behalf of the NHLBI's Office of Prevention, Education and Control (OPEC), provided a progress report on the following NCSDR education activities.

High School Sleep Curriculum. The "Sleep, Sleep Disorders, and Biological Rhythms" high school biology curriculum supplement has now been distributed. Initial data show that the schools are enthusiastic about the materials. The National Sleep Foundation (NSF) is promoting the use of the curriculum in its Sleep for Teens CD-ROM Toolkit.

Publications. The Healthy Sleep Handbook presents an overview of four common sleep disorders, and will be printed by the end of summer, 2005. NHLBI's web-based Diseases and Conditions Index (DCI) currently provides general information about sleep apnea. DCI topics that will subsequently be developed include restless legs syndrome, narcolepsy, problem sleepiness, and insomnia. A technical report on excessive sleepiness in adolescents and young adults was produced by a joint NHLBI/American Academy of Pediatrics Working Group and has been published in the June, 2005 issue of Pediatrics.

Garfield "Star-Sleeper" Campaign. Ms. Sommer provided a summary of the Garfield Star Sleeper Campaign's first 5 years of activity, noting that the contract with Paws, Inc., the studio that has partnered with NHLBI on the Star-Sleeper campaign, has been extended for an additional 5 years. The campaign initially formed community partnerships with a number of professional and voluntary organizations, and later partnered with Time Magazine's "Time for Kids" program to produce and distribute Garfield educational materials to 30,000 3rd grade teachers and their students

The campaign was designed as a multifaceted, science-based social marketing campaign that used 4 strategies to disseminate its messages: media relations, marketing and promotional activities, partnerships, and web-based initiatives. Materials developed for the campaign include a 48-page Fun Pad, a plush "Star Sleeper" doll, and a Web site with interactive games for children and information for parents, teachers, and health care professionals. Another corporate partner, Jordan's Furniture in New England, provides fun pads at no cost with the sale of each child's bed. Media events have been conducted in schools, and national contests have been held to generate press coverage. The campaign is currently assessing its priorities for program development during this 2nd 5-year period. Any subsequent educational activities of the Star-Sleeper campaign conducted by the NHLBI will also include an evaluation component.

During the discussion, the following comments were made:

- The Garfield campaign could consider targeting high-risk children (e.g., from low socioeconomic communities). NHLBI could also expand the Garfield campaign by sponsoring a contest for students in grades 6 and 7 and award prizes for the winning schools.

- NCSDR could look to the Robert Wood Johnson Foundation's Young Epidemiologists Society (YES) Award, which targets high school seniors who do independent study, as one potential model for any subsequent educational activities. Four of the top 10 winners this year did sleep-related projects and won scholarships for the study of obesity and sleep.

- Sleep messages could also be integrated into NHLBI's Childhood and Adolescent Trial for Cardiovascular Health (CATCH), which focuses on obesity, exercise, and nutrition and NHLBI's "We Can!" program focusing on childhood obesity..

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PUBLIC REPORTS

Ms. Georgi Bell, Executive Director, Restless Legs Syndrome (RLS) Foundation: Ms. Bell observed that RLS was not included in the top 10 sleep research priorities developed by SDRAB. She noted that RLS is common but unrecognized and under diagnosed; it needs more attention.

Dr. Edward Grandi, Executive Director, American Sleep Apnea Association (ASAA): Dr. Grandi reported that the redesigned ASAA Web site, www.sleepapnea.org, was launched March 30. ASAA sponsors more than 230 support groups for people with sleep apnea and is part of the AWAKE Network. This association is targeting communities at risk (e.g., inner-city, Native American, and Hispanic). The ASAA will host a session at the June meeting of the APSS in Denver.

Dr. Neal Farber, Co-President, Kleine-Levin Syndrome (KLS) Foundation: Dr. Farber reported that the KLS Foundation has partnered with Stanford University for a study by Drs. Emanuel Mignot and Isabel Arnouf. Approximately 200 case reports of KLS in the literature have been analyzed, and an article has been submitted for publication. A comprehensive information database is being maintained at Stanford. Other resources are a 24-page detailed questionnaire for patients and their parents, and the first large-scale collection of blood samples (included 114 samples from KLS patients and 164 from parents, as well as matched controls) for use in genetic and other studies.

Dr. Maureen Hannley, Chief Research Officer, American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) Foundation: Dr. Hannley noted that this is the first time the AAO-HNS has reported at the SDRAB. The Academy has 12,000 members internationally. Its areas of interest include allergic rhinitis, acute sinusitis, obstructive sleep apnea, and other sleep disorders. The Academy's National Center for Promotion of Research in Otolaryngology provides grants to researchers and advocates. An active clinical research network that includes both community-based and academic researchers is coordinated by the Duke Clinical Research Institute. A goal is to increase the amount of NIH funding for prospective clinical research to evaluate management options for conditions such as sleep disordered breathing (SDB) and surgical options for tonsillectomy (partial vs. radical), which will include postoperative polysomnography (PSG) at 3 and 6 months.

Dr. Eveline Honig, Executive Director, Narcolepsy Network (NN): Dr. Honig reported the Network's successful sleep disorder screening at eight locations nationwide in malls and universities. The NN hopes to work with other organizations. Though its membership has increased, funding from NHLBI and corporations has decreased. NN will hold its annual conference in Boston on November 11-13, 2005.

Mr. Jerome Barrett, Executive Director, American Academy of Sleep Medicine (AASM): Mr. Barrett reported that the AASM's annual meeting will be held June 28 in Denver. The AASM has published a revised International Classification of Sleep Disorders (ICSD-2). The American Board of Medical Specialties has reviewed and approved an application for a qualification examination. Thirty-seven programs will meet the application deadline of July 13, and the first exam will be held in September 2007. A 175-page book on the basics of sleep research, published by the Sleep Research Society (SRS), will help prepare those taking the exam.

Mr. Darrel Drobnich, Senior Director of Government and Transportation Affairs, National Sleep Foundation (NSF): Mr. Drobnich reported that National Sleep Awareness Week was held March 28-April 3, 2005, with representatives from 720 Sleep Centers and State and Federal agencies. The week's events reached more than 150 media markets. NSF will also launch the National Sleep Awareness Roundtable, which aims to increase awareness that sleep is as important as exercise and diet. NSF will present an Adolescent Sleep Symposium at the APSS meeting in Denver. It will distribute the "Sleep for Teens" toolkit, with Power Point presentations and free CD-ROMs, to increase awareness of the effects of early school start times. NSF has also produced a series on insomnia and has exhibited at several meetings.

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THE ROLE FOR EPIDEMIOLOGICAL STUDIES IN FURTHERING OUR UNDERSTANDING OF SLEEP AND HEALTH - Dr. Susan Redline

Dr. Redline explained that the objectives of epidemiological research are to: (1) identify and quantify risk factors for disease and identify susceptible subgroups; (2) identify the most effective therapies and approaches for prevention and treatment; (3) identify predictive diagnostic tests, and (4) predict and explain prognosis. This research includes both descriptive and analytic studies such as cross-sectional surveys, observational studies, and randomized controlled trials (RCTs). The epidemiology of SDB examines prevalence, risk factors, natural history with and without treatment, and short- and long-term response to therapy.

Dr. Redline presented an historical overview of the epidemiology of sleep apnea. In the 1980s, this included surveys of snorers and studies in the elderly. In the 1990s, several studies used objective PSG in large population samples. In 1994, the Sleep Heart Health Study (SHHS) was the first large-scale multicenter study of sleep apnea to look at cardiovascular and other consequences in a population of >6,000 adults. In 2000, sleep was added to other large-scale studies to examine morbidity and outcome data. In the 2000s, large-scale studies in Japan and India examined sleep apnea as part of a study of obesity prevalence. The 2004 Apnea Positive Pressure Long-term Efficacy Study (APPLES) is the first large-scale RCT of sleep apnea.

Before 1995, the importance of sleep duration to health was not appreciated. Adult sleep apnea was considered a disorder of middle-aged obese men with high prevalence in the elderly. There was no evidence of the effect on hypertension and no known ethnic variation. Pediatric sleep apnea was considered a genetic syndrome correlated with pulmonary and growth problems, and adenotonsillectomy was considered curative. After 1995, epidemiological studies quantified the public health burden of sleep disorders with findings that include the following:

- Sleep apnea affects 1-3 percent of children, 5-15 percent of middle-aged adults, and >20 percent of the elderly. It is more common in women than had been appreciated (with a male/female ratio of 3:1), and there is a relationship to menopause/hormones.

- There is a higher prevalence of sleep disorders in the elderly, young African Americans (a 4-6-fold risk), and possibly other ethnic groups (Hispanics and non-obese Asians). SDB is associated with age, weight, and obesity.

- More than 50 percent of obstructive sleep apnea patients are obese (especially with "central obesity") and obesity led to increases in sleep deprivation and increased comorbidities. Common genes for obesity and SDB have been identified.

- Prevalence increases with high blood pressure and heart disease. A higher number of episodes per hour is related to a higher incidence of cardiovascular disease (CVD).

- Childhood obstructive sleep apnea is associated with a history of prematurity/neonatal exposure, sinus problems and asthma.

Dr. Redline also reviewed data from several large-scale studies that revealed associations between sleep disorders and arrhythmia, glucose level, neurocognitive deficits, depression, falls/fractures, risk of mortality, and quality of life. She noted that vulnerable groups-such as minorities and pre term infants-have enhanced susceptibility to other stressors that adversely affect growth, development, and academic performance. A big question is whether children with SDB are at increased risk of learning/behavior problems that persist. In summary, sleep disorders have numerous health effects though their magnitude and reversibility is unclear. There is a need for large-scale rigorous clinical trials that include sleep disorders as a risk factor or outcome.

Asked if epidemiologic studies can be piggybacked on other clinical studies, Dr. Redline said that it depends on the study, and this may be hard to incorporate in a competitive application.

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UPDATE: INSTITUTE OF MEDICINE STUDY-Dr. Bruce Altevogt

Dr. Altevogt provided an update on the IOM study. Study sponsors include the NIH, AASM, NSF, and SRS. The IOM Committee on Sleep Medicine and Research will (1) review and quantify the public health significance of sleep health, sleep loss, and sleep disorders based on current knowledge; (2) identify gaps in the public health system related to understanding, management, and treatment of sleep loss and sleep disorders, and assess the adequacy of the current resources and infrastructures for addressing the gaps; (3) identify barriers and opportunities for improving and stimulating research, education, and training; and (4) develop a comprehensive plan for enhancing sleep medicine and research. The Committee is chaired by Dr. Harvey Colten and has 14 additional members, including Dr. Redline. The IOM study's 18-month time line includes five meetings with both open and closed sessions, and a report produced in spring 2006. The first meeting was held in April, 2005, and focused on the public health significance of sleep deprivation and disorders. The second public meeting will be held on June 29-30 in Washington, DC, and will include sessions addressing surveillance programs/technologies, organization impediments, model interdisciplinary programs, and education/training. For more information, see www.iom.edu/sleep. Dr. Altevogt invited comments and can be reached at baltervogt@nas.edu. Dr. Hunt added that the quality of the study outcome will be enhanced by comprehensive SDRAB input to the Panel. He asked members to share their comments and provide a broad perspective on behalf of the sleep community. Dr. Redline asked members to fill out the AASM/SRS survey (on their website).

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OTHER BUSINESS

Appreciation to Departing Board Members-Dr. Carl Hunt

Dr. Hunt acknowledged the contributions of Board members completing their terms of office with a letter of appreciation, certificate, and a "Star Sleeper" doll. Dr. Dolan-Sewell, who served as an ex officio member representing the National Institute of Mental Health, will be leaving NIH at the end of the month. The three other members rotating off the board on June 30 are Drs. Sarah Caddick, Stuart Quan, and Clifford Saper.

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

Dr. Dolan-Sewell reported that the OMAR's SOS Conference on Manifestations and Management of Chronic Insomnia in Adults will begin on Monday, June 13. The conference will include 1-1/2 days of presentations. The Consensus Panel will then meet in closed session to draft the consensus statement. Following a public discussion the following morning and revision of the Statement as needed, the final statement will be presented at a press conference. Dr. Dolan-Sewell encouraged SDRAB members to attend the conference, which will also be Web cast and video-archived.

National Sleep Disorders Research Plan-Dr. Quan and Board

The SDRAB was charged at its last meeting to revise and update their recommendations as needed for sleep research priorities. Drs. Quan, Lee and Pelayo reported on the results of their recent conference call. They suggested that the Board review the research programs NCSDR and the Trans-NIH SRCC have sponsored in recent years. They agreed that piggyback studies are a fruitful and economical way to conduct epidemiological studies without a separate large epidemiology trial. The IOM study will be addressing training needs.

NIH Sleep Grant Reviews-Dr. Quan and Board

Dr. Quan reported that since 2003, only about 70 competing applications for K awards had "sleep" or "circadian" in their title, and only 10 of these were funded. Thirty of the 70 were submitted to the NHLBI.) . During the Board discussion, it was noted that each Institute has its own approaches to K awards, and that K applications compete only with each other. However, sleep competes with other areas and may not do as well as more "mature" areas.

Remarks/Discussion -Dr. Elizabeth Nabel

Dr. Nabel, the new NHLBI Director, said that she is looking forward to getting to know the SDRAB members, and she thanked them for the work they are doing. She noted that there is a focus on training and mentoring across the NHLBI. While funding is likely to be flat, NHLBI does not want to lose investigators. She asked the Board for advice on strategies to bring new sleep investigators into the field and support them.

The group continued the discussion of grants for sleep research. The point was made that because sleep research is a relatively small research area, the pool of investigators may be smaller than in other areas. Asked about the status of sleep-related SCOR grants, Dr. Nabel said that this mechanism has been used since the 1970s, but other mechanisms are available to support clinical research. For example, Clinical Networks used in pediatric asthma programs have made important contributions. Centers of Excellence also support clinical research. She asked the Board for recommendations on how to advance basic and clinical sleep research and said that NHLBI will be starting a strategic planning process to identify goals for the next decade. Dr. Nabel is looking forward to participating in the APSS meeting in Denver later in June and to meeting a broad representation of the extramural sleep-research community.

FINAL DISCUSSION

Dr. Quan reported that the Board will form a group to identify goals for research and training. He will encourage broad input from investigators and clinicians. The following comments were made by Board members:

- Provide a justification/rationale for sleep clinical networks.

- Determine how post-doctorate trainees are doing sleep research. The Sleep Research Society may be an appropriate partner with SDRAB in this regard.

- Determine the extent to which potential funding barriers encourage investigators to leave the sleep field. The IOM study will also be addressing this issue.

- Two ways to increase the likelihood of success are to have some reviewers with sleep expertise and to educate study sections about why sleep is important.

- Create an awareness of sleep research opportunities among potential trainees. Effective strategies to accomplish this need to be addressed.

Dr. Hunt asked that an executive summary of recommendations for sleep research and training be developed as part of the NHLBI strategic planning process now being initiated.

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.

Rafael Pelayo M.D., Chair
Sleep Disorders Research Advisory Board

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

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