The 18th meeting of the SDRAB was convened at 9:05 a.m. on Wednesday, June 25, 2003, in Room D of the Natcher Conference Center on the National Institutes of Health (NIH) campus in Bethesda, Maryland. Stuart Quan, M.D., presided as Chair.

TABLE OF CONTENTS

Attendees
Opening Comments
Adoption of December, 2002 Advisory Board Meeting Minutes
Report of the Director NCSDR
Women's Health Initiative: Dr. Jacques Rossouw, WHI Project Officer
Chronobiology and Cancer: Dr. Jeffrey White, National Cancer Institute
Education Activities
Election of Board Chair for 2003-2004
Institute of Medicine (IOM) Proposal: Dr. Emmanuel Mignot
Board Discussion
Three Board Members Complete Term of Office
Public Reports
Board Resolution: IOM Study
Adjournment
Certification

Sleep Disorders Research Advisory Board Page

BOARD MEMBERS PRESENT

Dr. Stuart F. Quan (Chair), University of Arizona
Dr. Gene Block, University of Virginia
Dr. Mary Carskadon, Brown University School of Medicine (by phone)
Dr. Kathryn Lee, University of California, San Francisco
Ms. Sandra McGinnis, Patient Advocate
Dr. Susan Redline, Case Western Reserve University
Dr. Michael Sateia, Dartmouth Medical School
Ms. Dara Spearman, University of Michigan

BOARD MEMBERS ABSENT

Dr. Sarah Caddick, Wadsworth Foundation
Dr. Rafael Pelayo, Stanford University
Dr. Clifford Saper, Harvard Medical School
Mr. Phillip L. Williams

EX OFFICIO MEMBERS PRESENT

Dr. Robert Wolfe Greene, University of Texas Southwestern Medical Center
Dr. Carl E. Hunt, SDRAB Executive Secretary
Dr. Israel Lederhendler, National Institute of Mental Health
Dr. Merrill Mitler, National Institute of Neurological Disorders and Stroke
Dr. Andrew Monjan, National Institute on Aging
Dr. Marian Willinger, National Institute of Child Health and Human Development

EX OFFICIO MEMBERS ABSENT

Colonel Gregory Belenky, Walter Reed Army Institute of Research

LIAISON MEMBERS PRESENT

Dr. Deborah Ader, National Institute of Arthritis and Musculoskeletal and Skin Diseases
Dr. Daniel Chapman (by phone), Centers for Disease Control and Prevention
Dr. Harold Gordon, National Institute on Drug Abuse
Ms. Adrienne Oneto, Bureau of the Census
Dr. Thomas Raslear, Department of Transportation
Dr. Ellen Witt, National Institute on Alcohol Abuse and Alcoholism

LIAISON MEMBERS ABSENT

Dr. Mary Leveck, National Institute of Nursing Research
Dr. Nancy Pearson, National Center for Complementary & Alternative Medicine
Dr. Christopher Platt, National Science Foundation
Dr. Roger Rosa, National Institute for Occupational Safety and Health
Dr. George Ruby, Department of Occupational Safety and Health Administration
Dr. Bette Siegel, NASA

OTHER FEDERAL EMPLOYEES PRESENT

Mr. Al Golden, NCSDR, NHLBI
Ms. Sue Rogus, NHLBI
Dr. Jacques E. Rossouw, Women's Health Initiative, NHLBI
Ms. Susan Sagusti, NHLBI
Ms. Ellen Sommer, NHLBI
Dr. Samuel Speciale, National Institute on Aging
Dr. Michael Twery, NHLBI
Dr. Jeffery D. White, National Cancer Institute

INVITED GUESTS PRESENT

Dr. Emmanuel Mignot, Stanford University

MEMBERS OF THE PUBLIC PRESENT

Dr. Jerry Barrett, American Academy of Sleep Medicine
Dr. Robert Basner, American Thoracic Society
Ms. Georgiana Bell, Restless Legs Syndrome Foundation
Ms. Pat Britz, National Sleep Foundation
Ms. Christin Engelhart, American Sleep Apnea Association
Ms. Joanne Hawana, FDC Reports - "The Blue Sheet"
Ms. Judy Milton, Sleep Research Society
Ms. Nancy Moy, SRI International
Dr. Andy Pope, Institute of Medicine
Ms. Whitney Tull, Health and Medicine Council of Washington

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

Dr. Stuart Quan welcomed board members and other members of the audience. Board members, and staff including those present by phone, introduced themselves. Dr. Hunt called attention to the materials in the meeting book, and he asked members to review the statement on conflict of interest.

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ADOPTION OF MINUTES FROM DECEMBER 11, 2002 MEETING - Dr. Stuart Quan

It was moved and seconded that the Minutes of the December 11, 2002, SDRAB meeting be accepted as submitted. The Minutes were adopted unanimously.

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

NCSDR coordinates many of its activities through the Trans-NIH Sleep Research Coordinating Committee. The committee is composed of representatives from 10 NIH institutes and centers, each of which has a representative on the Sleep Disorders Research Advisory Board (SDRAB) as either a liaison or ex officio member.

Dr. Hunt discussed NIH sleep-related research funding. The total NIH sleep-related research funding increased from $72,815,000 in 1995 to $175,022,000 in 2002, a 140-percent increase. Funding for sleep research has more than doubled with the doubling of total NIH research funding. The number of applications for sleep research funding and the total number of sleep grants have increased faster than the overall NIH research funding, representing 1.2% of the total NIH budget in 2002 compared 0.9% in 1996.

New Initiatives:

- Responses to the RFA entitled "Role of Sleep and Sleep-Disordered Breathing in Metabolic Syndrome" are being reviewed. $3 million has been designated for this RFA. The goal of this RFA is to elucidate the relationship of sleep deprivation and sleep-disordered breathing to characteristics of the metabolic syndrome. Successful applicants will be funded in FY 2004.

- The program announcement entitled "Sleep Disturbance in Parkinson's Disease and Parkinson-Like Conditions" was released in June 2003. This new initiative is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and cosponsored by NHLBI.

Recent Conferences and Workshops:

- The report of the Cardiovascular Consequences of Sleep-Disordered Breathing, held in September 2002, has been completed and is being submitted for publication.

- The report from the workshop entitled "Restless Legs Syndrome: Diagnosis and Diagnostic and Epidemiological Tools," held in May 2002, was published in the journal Sleep Medicine (2003;4: 101-119).

- The report from the conference entitled "Sleep, Fatigue, and Medical Training: Optimizing Learning and the Patient Care Environment," held on October 28-29, 2001, was published in the journal Sleep (2003;26:218-225).

- A report is being developed for the workshop entitled "Effects of Sleep Disorders and Sleep Restriction on Adherence to Cardiovascular and Other Disease Treatment Regimens: Research Needs," held on March 11-12, 2003.

- The workshop entitled "Making Sense of SCN Heterogeneity: The Tissue Is the Issue" was held on June 16-18, 2003. The National Institute of Mental Health (NIMH) sponsored this workshop.

- The workshop entitled "Neuro-Immune Mechanisms and Chronic Fatigue Syndrome (CFS): Will Understanding Central Mechanisms Enhance the Search for the Causes, Consequences, and Treatment of CFS?" was held on June 16-18, 2003. The workshop was sponsored by the Office of Research on Women's Health, Trans NIH Working Group for Research on CFS, National Institute of Nursing Research (NINR), and NCSDR (NHLBI).

Sleep and Sleep Disorders in Women:

This monograph on sleep and sleep disorders in women has been prepared for publication in the American College of Obstetrics and Gynecology monograph series. Their circulation includes 17,000 practicing obstetricians and gynecologists. The monograph will be published in Spring, 2004. Topics include sleep, health, and the diagnoses and management of various sleep disorders.

State of the Science Conference on the Treatment of Chronic Insomnia:

This conference is being planned under the auspices of the Office of Medical Applications of Research (OMAR). NIMH is the sponsor of this conference; NIH cosponsors currently include NHLBI/NCSDR, NCCAM, NIA, NIAAA, NIDA, NINDS, NINR, ORWH, and NCSDR. Non-NIH federal co-sponsors currently include the VA, FDA, and DOT. Dr. Hunt outlined the key questions of the conference, and reviewed the conference planning process. An organizational meeting will be held July 29, 2003 and will include all cosponsors and the Agency for Healthcare Research and Quality (AHRQ). The next step will be to appoint the planning committee and develop the agenda for a meeting in December 2003.

National Sleep Conference:

A high profile national conference entitled "Frontiers of Knowledge in Sleep and Sleep Disorders: Opportunities for Improving Health and Quality of Life" has been scheduled for March 29-30, 2004. The sponsor of the conference is the Trans-NIH Sleep Research Coordinating Committee; cosponsors of the conference are the American Academy of Sleep Medicine (AASM), National Sleep Foundation, Sleep Research Society, American Sleep Apnea Association, Restless Legs Syndrome Foundation, and the Narcolepsy Network.

National Children's Study:

This is a study of the environmental effects on child health and development. The lead institutes within NIH are NICHD and NIEHS. Other federal lead agencies are the Environmental Protection Agency and the Centers for Disease Control and Prevention. The study involves 100,000 subjects and has 5 outcome themes and hypotheses. Twenty-two working groups are involved in planning the study. One of those working groups is the Development and Behavior Working Group, on which Drs. Hunt and Carskadon serve as members. A subcommittee of this Working Group, chaired by Dr. Carskadon, is developing a proposal for core sleep-related data that will be collected during pregnancy and from 0-5 years of age.

2003 National Sleep Disorders Research Plan:

The executive summary of the plan has been published in the journal Sleep (2003;26: 253-257). The plan is also posted on the NCSDR website as a .pdf file. A government printing of 8,000 copies is in process. Editorials and commentaries on the plan have been published in various journals (e.g., Sleep, Research in Nursing & Health), and submissions to additional journals are being developed, including a clinical update coming out in the October issue of Occupational Health Nursing [AAOHN] that concludes with a reference to the National Sleep Disorders Research Plan.

Additional commentaries need to be published, however, to ensure broad dissemination of the plan to current and potential trainees, potential interdisciplinary sleep research partners, and public and private funding agencies. Most of the commentaries published to date have been in clinical journals, and assistance from the Board is needed to ensure also reaching basic science audiences. Since the critical mass of scientists and clinicians necessary to fully implement the plan does not currently exist, it is hoped that the Plan will serve as a stimulus for new investigators and trainees to enter the field.

Dr. Quan thanked Dr. Lee and her colleagues for writing editorials in several journals. He encouraged other members of the board and members of the audience to inform others about the plan.

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WOMEN'S HEALTH INITIATIVE(WHI): Dr. Jacques Rossouw, WHI Project Officer, NHLBI

Dr. Rossouw, the WHI Project Officer, discussed the history and timeline of WHI. WHI began at NIH in 1991. The clinical coordinating center was funded in 1992 and the clinical centers were funded in 1993-1994. During 1993-1998, participants were enrolled. In 1997, the program office was transferred from the Office of the Director of NIH to NHLBI. In 2000 (and repeated in 2001), an excess of cardiovascular risk was observed in the hormone trials. In 2002, the trial of estrogen and progestin was stopped early. The remaining trials are scheduled to end in 2005. Funding for the clinical coordinating center will end in 2007.

Key points from Dr. Rossouw's description of WHI include:

- WHI has 40 clinical centers throughout the United States. Each center recruited more than 3,500 participants.

- The study has four clinical trials-two hormone trials, a calcium and vitamin D trial, and a dietary modification trial-and one observational study. Participants in the WHI clinical trials totaled 68,133; on average, they were followed up for 8.4 years. Women who were ineligible for the clinical trials or who chose not to enroll in the clinical trials were enrolled in the observational study. More than 93,000 women were enrolled in the observational study.

- The objectives of the WHI observational study are to improve estimates of known predictors, find new predictors and markers, evaluate the effects of change in biomarkers on disease, and compare results of the study with the clinical trial cohort.

- WHI participants were postmenopausal women, aged 50 to 79, who had no plans to move in the next 3 years, who were free of serious illness, and who gave informed consent.

- Three significant health outcomes of the WHI estrogen and progestin trial are the following: The trial revealed early harm for coronary heart disease, continuing harm for stroke, and increasing harm for breast cancer. This risk-benefit profile was unsuitable for primary prevention of chronic diseases in postmenopausal women. The global index did not incorporate data from measures of health-related quality of life.

- The objectives of the quality of life (QOL) study were to test the effects of estrogen and progestin on health-related quality of life (e.g., sleep, cognitive functioning) and to assess whether the effects of hormone therapy varied depending on certain factors (e.g., age, body mass index, menopausal symptoms).

- Some measures used in the QOL study were RAND-36, a depression score, a WHI insomnia rating scale, a sexual satisfaction question, and a modified minimental state examination.

- The primary results of the quality of life study were the following:

> No clinically meaningful differences existed between treatment and placebo groups after 1 year. Three of the thirteen measures showed statistically significant improvements in physical functioning, bodily pain, and sleep (0.4 difference on a 20 point scale).

> Compared to baseline-women aged 50-59 who reported moderate-to-severe vasomotor symptoms-75 percent of the estrogen and progestin group and 50 percent of the placebo group showed reduction in hot flashes and night sweats after 1 year.

> Compared to baseline-women aged 50-54 who reported moderate-to-severe vasomotor symptoms-women showed an improvement in sleep (a 1-point difference on a 20-point scale) after 1 year.

- In the clinical trials, all women receive the QOL questionnaire at baseline, at 1 year, and at closeout; some of them receive the QOL questionnaire every 3 years. In the observational study, all women receive the QOL questionnaire at baseline and after 3 years. Data are available at those intervals.

- Designed by WHI QOL experts, the WHI insomnia rating scale has undergone a validation study, which will be published. The scale asks questions about sleep during the prior 4 weeks. Four items assess problems with initiation and maintenance of sleep. One item assesses the quality of sleep. The questionnaire includes questions on sleep (e.g., questions about taking medication or alcohol to sleep, daytime napping, snoring, and average duration of sleep).

Dr. Rossouw discussed procedures for accessing WHI data. Extensive data have been accumulated but only a fraction of the data has been published to date. WHI investigators have priority in accessing the data. A procedure for collaborating with investigators exists. To access data at this point in the WHI timeline, non-WHI investigators must team up with a WHI investigator. A list of investigators is posted on the WHI Web site (www.nhlbi.nih.gov/whi ). In October 2003, a monograph, which contains all the baseline data in the clinical trial and observational study, will be published in International Journal of Epidemiology. In December 2003, baseline data from the observational study will be available as a limited access dataset at www.nhlbi.nih.gov/resources Funding after late 2006 will include support of a service infrastructure and a broad agency announcement (BAA) to the entire scientific community. About $35 million will be set aside for this BAA. WHI and non-WHI investigators can apply for this funding. Other Institutes may wish to co-sponsor the BAA to enable study of additional scientific issues. In Fall, 2008, clinical trial data will also be available as a limited access dataset. WHI does not have a committee that analyzes WHI's sleep data. However, WHI has a behavioral committee that is validating the sleep questions. Dr. Sally Shumaker is chair of the group interested in sleep. Dr. Rossouw will facilitate SDRAB members establishing contact with appropriate WHI investigators. Dr. Shumaker is suggested as an appropriate person to contact concerning WHI sleep data. Dr. Rossouw can be contacted at RossouwJ@NHLBI.NIH.GOV. Dr. Shumaker can be contacted at shumaksa@wfu.edu

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CHRONOBIOLOGY AND CANCER - CURRENT PROGRAMS AND FUTURE OPPORTUNITIES: Dr. Jeffrey White, National Cancer Institute

Dr. White is the Director of the Office of Cancer Complementary and Alternative Medicine (OCCAM) at the National Cancer Institute (NCI). OCCAM develops NCI's complementary and alternative medicine (CAM) agenda, coordinates NCI's CAM projects; serves as NCI's liaison with other government and nongovernmental organizations interested in CAM cancer; and is an interface to the public, CAM community, and oncology community concerning CAM cancer research.

Dr. White discussed approaches relevant to OCCAM's mission. These approaches include unconventional uses of conventional approaches (e.g., off-label uses of nonchemotherapy drugs); natural product drug development; certain dietary supplements; mind-body interventions (e.g., psychotherapy); multidisciplinary practices; support of host defense mechanisms, and the interface of human physiology with cancer therapeutics (e.g., chronobiology).

Dr. White commented on the Innovative Cancer CAM Initiative in Cancer Centers. Spanning fiscal years 2001-2003, this initiative is designed to increase high-quality CAM research, to encourage cancer centers to develop CAM programs, and to encourage collaborations with CAM practitioners. This initiative funds six cancer centers and has a maximum of $400,000 per year. Dr. White mentioned that some of the NCI-sponsored cancer centers conduct sleep research.

Dr. White described a February 2003 OCCAM invited speaker series on chronobiology, melatonin, and cancer. The summary of this meeting is in press, and a webcast of the meeting is on the OCCAM Web site.

Dr. White commented on NCI's sleep and chronobiology research in the period 1993-2003. This research included a focus on fatigue, sleep, and circadian rhythms in breast cancer; the effect of opioids on sleep and fatigue; insomnia intervention for breast cancer survivors; the development of a fatigue assessment sleep/activity monitor; and circadian physiology. The largest interest in sleep research appears to be in the Division of Cancer Control and Population Sciences (DCCPS). At least eight program directors in DCCPS have sleep in their portfolio. Sleep-cancer research appears to be relatively low in proportion to its potential importance in improving patient care, however, and chronotherapy research is not widespread in the United States.

Participants discussed sleep-cancer research topics that could be explored in the future. The relationship between deterioration in the sleep-wake cycle and the terminal stage of cancer needs to be explored. Because deterioration in that cycle may promote disease, it may be beneficial to maximize a cancer patient's sleep and wakefulness. Another board member commented that a change in the quality of sleep affects the immune system and hence may increase susceptibility to various cancers. Dr. White agreed that it would be beneficial to design studies to examine those two relationships.

Participants discussed strategies for stimulating interest in sleep-cancer research in the scientific community. Dr. White said that OCCAM would be interested in exploring topics of mutual concern (e.g., chronobiology, circadian time chemotherapy) with SDRAB. It was suggested that a workshop might be an appropriate forum to develop research hypotheses and to bring together the relevant disciplines. Since large, multicenter clinical trials constitute the bulk of NCI-supported work, the language of future NCI initiatives can be expanded to include sleep content. This inclusion would encourage collaborative groups to incorporate sleep measures in data collection. There is also a need to support research using animal models.

Dr. Hunt commented that the Trans-NIH Sleep Research Coordinating Committee looks forward to productive discussions with NCI representatives and the development of interdisciplinary programs of mutual interest.

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

Ms. Rogus, Coordinator of NCSDR's Sleep Education Activities, updated the audience on the high school curriculum on sleep, sleep disorders, and biological rhythms. At the meeting of the National Science Teachers Association, the curriculum was well received. The curriculum will be printed in late 2003. The curriculum will be made available to all high school science teachers and will be posted on the Web site of the Office of Science Education, the lead office in preparing the curriculum.

Ms. Sommer, Senior Health Communications Specialist, updated the board concerning the Garfield Star Sleeper Campaign. OPEC will have a new communications contract in August to assist in developing future campaign activities. The "How I Get a Heap of Sleep" Contest, held in the Fall of 2002, was targeted at to 7- to 9-year-olds. Contestants were asked to describe in writing three things that they did before bed to help them get a good night's sleep. There were more than 1,000 entries. Three grand prize winners and 20 first-place winners were selected. Sample winning entries included having a warm bath and bedtime story, finishing homework early, and not watching television when it is time to go to bed. Dr. Lenfant, Dr. Hunt, and Garfield attended a special event in January at which the Grand Prize Winners received their awards. The contest and event received excellent media coverage, including national and local television in many cities (e.g., New York, Chicago, San Francisco). Major newspapers (e.g., The Wall Street Journal) carried stories on the winners' event.

Ms. Sommer displayed the Garfield Star Sleeper Web site, showed some of the childrens' games, shared May 2003 usage of the Web site (roughly 39,000 visits in May), and outlined future directions for the Web site, including expanded content for health care providers and new games.

Ms. Rogus discussed future educational activities. They include establishing new and innovative partnerships, developing a strategic plan for promoting the Garfield campaign, disseminating the high school curriculum, publishing the Working Group on Sleepiness and Adolescents' paper in the journal Pediatrics, assessing and revising existing factsheets, and reaching minority audiences (e.g., Hispanics and African-Americans) with sleep messages.

Dr. Hunt commented that a proposal was being developed to evaluate the Garfield campaign. Another board member recommended assessing knowledge and attitudes of children and teachers as a first step in outcomes assessment of the Garfield campaign.

Board members discussed target audiences of the high school curriculum on sleep, sleep disorders, and biological rhythms. Dr. Quan suggested that AASM inform its members about the curriculum. The target audience for the curriculum should include school psychologists, school nurses, athletic coaches, physical education teachers, district school superintendents, and behavioral science teachers. Dr. Quan suggested using this curriculum for college students.

Board members discussed dissemination of the curriculum. It was suggested that sleep experts go to schools and share their clinical experiences with teachers, and that the compilation of a list of sleep experts who could volunteer to educate their communities on sleep would help to ensure that the curriculum has priority in their respective communities' high schools. It was also suggested that partnering with local drivers' education programs would be useful, and could help incorporate parts of the curriculum To advance the curriculum in a community, collaborating with a public figure who has a sleep disorder was also recommended .

Board members suggested other methods for disseminating NCSDR's sleep messages in the community, including producing and disseminating a CD on Garfield to pediatrician offices. Another board member suggested distributing the NCSDR bookmark to public libraries and bookstores.

Discussion then focused on NCSDR Fact Sheets and other educational brochures and materials. Dr. Hunt alerted board members that the educational materials on sleep apnea and restless legs syndrome are scheduled to be reviewed for possible updating in the near future. Ms. Engelhart, of the American Sleep Apnea Association, suggested that the title of the sleep apnea materials for providers be changed to "Recognizing Sleep-Disordered Breathing in Your Patient Population" and that the text "when you are prescribing Continous Positive Airway Pressure be revised.

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ELECTION OF BOARD CHAIR FOR 2003-2004

During this closed session, Dr. Stuart Quan was unanimously re-elected Chair of the Board for the year beginning July 1, 2003.

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SLEEP DISORDERS: INSTITUTE OF MEDICINE (IOM) PROPOSAL-Dr. Emmanuel Mignot

Dr. Mignot, Professor of Psychiatry and Behavioral Sciences and Director of the Center for Narcolepsy at Stanford University, discussed the growth in sleep medicine and sleep research in the past 30 years. In 1970, few sleep centers existed worldwide. Today, more than 2,000 specialized sleep centers are in the United States alone, and there are more than 4,000 sleep medicine practitioners. Although the number of sleep practitioners has increased rapidly, the growth in number of sleep researchers has been much slower and there are presently too few sleep researchers to meet the needs addressed, for example, in the 2003 National Sleep Disorders Research Plan. Still unknown are the causes of restless legs syndrome and insomnia, the relationship between sleep disorders and other diseases (e.g., insomnia and depression), and the mechanism by which sleep disorders affect the progression of other diseases. It is imperative that researchers from other fields work with sleep researchers to answer many puzzling multidisciplinary, sleep-related questions.

Dr. Mignot discussed causes for the lack of qualified sleep researchers. One cause is the absence of established career paths (e.g., future faculty positions) in the sleep discipline. Another cause is that there are not sufficient numbers of sleep clinicians to meet the demands of the large patient population and also meet the needs for additional clinical sleep research.

Dr. Mignot suggested that the sleep field would benefit dramatically from independent review and guidance, and that the Institute of Medicine (IOM) is uniquely positioned to conduct such a review. Nationally recognized and multidisciplinary, IOM advises national decision makers on issues of health, biomedical research, and health policy. The majority of its studies are requested and funded by the Federal Government. IOM members include high-ranking and well respected scientists, researchers and academicians. As such, IOM recommendations have wide-ranging credibility and can stimulate change not only at federal agencies such as NIH, but also within academic health centers.

Dr. Mignot proposed three tasks for the IOM. First, IOM could review the current state of sleep medicine and research in medical schools. Second, IOM could identify the structural barriers to care, research and training. Third, IOM could propose solutions (especially solutions regarding training).

Dr. Mignot posed questions to the board. What is the most important question that IOM should address? What is the best format? How can effects be maximized at NIH and in academia?

The question of how much of the $175 million spent by NIH in 2002 on sleep research was actually used to train sleep investigators was raised. What is the ratio? How does this ratio compare with other fields at the same level of development as the sleep field? It was pointed out that the problem was not the scarcity of training grants but the lack of a structure that incorporates sleep research, training, and medicine in academia in the same way that happens in other disciplines, e.g. cancer.

Dr. Pope, representing the Institute of Medicine, described funding of IOM projects. Modern projects usually involve several cosponsors, including IOM. Nonfederal agencies can contribute to IOM studies. There are three ways in which IOM studies are initiated: (1) Congress may instruct IOM to conduct a study, (2) an agency, a group of agencies, or an advisory board may suggest that IOM perform a study, or (3) a board within IOM may suggest that IOM perform a study.

Dr. Pope described the two types of IOM studies. IOM conducts traditional studies (e.g., the report on medical errors titled To Err Is Human: Building a Safer Health System (2000)). These studies involve a 12- to 15-member committee, which meets four or five times; span 12-18 months; and cost approximately $600,000-850,000. IOM also conducts workshop-based studies; they are not as in-depth or comprehensive, but are only about half as expensive. IOM primarily conducts reviews of existing research data; when necessary IOM can ask a sponsor to collect new data.

Dr. Pope cited IOM's 1985 Injury in America Report and compared the field of injury control and prevention in 1985 with the sleep field today. Prior to the IOM report, only a few persons considered the injury problem serious. The IOM report identified injury as a serious public health problem. The IOM report led to the creation of the Center for Injury Control and Prevention in the Centers for Disease Control, and the field is now large.

There was the suggestion that a workshop-based study would be inadequate. Federal and nonfederal agencies would be involved. Two types of training would occur: training that stems from bringing in scientists from other disciplines and training that is traditional (e.g., fellowships).

One follow-up comment pointed out that the interfacing of sleep with other disciplines could serve as a model in academia for interdisciplinary team research. The IOM proposal should emphasize that point.

Following additional SDRAB discussion, a consensus was reached to develop a formal recommendation that can be included in these Minutes and directed to NCSDR and to the Trans-NIH Sleep Research Coordinating Committee. Dr Quan will draft this recommendation and circulate it to Board members for further revision, followed by an electronic ballot.

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DISCUSSION

A. 2003 National Sleep Disorders Research Plan: Dissemination Plans and Opportunities

Board members commented on dissemination of the research plan. Dr. Sateia is pursuing the inclusion of an editorial in the American Journal of Psychiatry. An alternative may be an article in the American Psychiatric Association monthly newsletter.

B. 2003 National Sleep Disorders Research Plan: Prioritization of Recommendations and Next Steps

Dr. Quan asked the board to advise NCSDR and the Trans-NIH Committee on implementing the research plan. What should be the order of priority for implementing the plan's recommendations?

In response, board members proposed several future steps. Dr. Quan expressed the need for proposals that translate the known (e.g., the treatment of insomnia) in a form useful to the public; he also expressed the need to know more about the neurobiology of sleep-disordered breathing. It was stated that studies should examine the effect of sleep disorders treatment on existing mental illnesses and their development. The effect of sleep disorders treatment on physical illnesses also need to be examined. Studying the influence of sleep disorders on the progression of disease was also recommended.

A parallel strategy to increase the body of scientific knowledge, and at the same time translate or apply what is currently known to improve public health was discussed.

Suggestions then focused on mood disorders and the neurobiology of restricted sleep. Using the 2001 report of the workshop on the neurobiology of restricted sleep as a guide, research programs need to be implemented to enhance our understanding of the neurobiology of insomnia and examine the effects of insomnia on other medical conditions, especially mood disorders.

The discussion then focused on the relationships between sleep disorders, insomnia and chronic illnesses. This is another area for future reseach emphasis.

C. Other Issues

An unresolved question from the December 2002 SDRAB meeting pertains to where sleep-related applications submitted to NIH are reviewed. NCSDR and the Trans-NIH Committee will continue to investigate this issue.

Dr. Quan read a letter from the board of directors of the American Sleep Apnea Association. The board asked SDRAB to encourage the National Health and Nutrition Examination Survey and other national surveys to include questions on sleep apnea. Ms. Engelhart pointed out that if questions were included, data obtained from the answers could be included in NHLBI's Morbidity and Mortality Chart Book. Dr. Quan stated that SDRAB would support the inclusion of sleep questions on national surveys.

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THREE BOARD MEMBERS COMPLETE TERM OF OFFICE

Dr. Hunt announced that the term of office expires 6-30-03 for Dr. Mary Caskardon, Ms. Dara Spearman, and Ms. Sandra McGinnis. Dr. Caskardon has contributed substantially to the sleep field and to the activities of the SDRAB. Ms. Spearman, a third-year medical student at the University of Michigan, has provided a unique and important perspective for the SDRAB. Ms. McGinnis, a patient advocate, has also brought a unique perspective to the Board, and has been instrumental in promoting community-based opportunities for implementation of Garfield campaign activities. Dr. Hunt thanked them for their service on the board and presented them with a letter from Dr. Lenfant, a certificate from NIH, and a Garfield doll.

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PUBLIC REPORTS

A. Sleep Research Society (SRS)-Ms. Judy Milton

Ms. Milton summarized the society's 2003 activities. At the 2003 APSS meeting, SRS presented its Distinguished Scientist Award and its young investigator awards-one for human research and one for animal research. To commemorate the 50th anniversary of the discovery of REM sleep, SRS bestowed awards for seminal contributions in sleep research and recognized founders who had made contributions between 1952 and 1962 and significant early contributors who made contributions from 1963 to 1972. SRS bestowed 78 travel awards to student members to attend the June, 2003 APSS meeting. More than 200 persons attended the society's annual trainee day. The SRS board has revised its bylaws and distributed them to members for them to vote on the bylaws.

B. Restless Legs Syndrome Foundation (RLS)-Ms. Georgiana Bell

Ms. Bell summarized the foundation's 2003 activities. The foundation recently celebrated its 10-year anniversary. The foundation has produced a CD entitled "Understanding and Diagnosing Restless Legs Syndrome." At the APSS meeting, foundation staff distributed 1,100 of the CDs and gave a 2-hour presentation on restless legs syndrome; more than 375 persons attended the presentation. The foundation is translating its materials into six languages, is producing international Web sites, is updating and expanding its core Web sites, and expanding its brain bank program and its research funding program.

C. American Sleep Apnea Association (ASAA)-Ms. Christin Engelhart

Ms. Engelhart highlighted ASAA's 2003 activities. ASAA's pediatric sleep apnea pieces were popular. ASAA's REM study, presented at the APSS meeting, received significant media interest. ASAA has been assisting the American Society of Anesthesiologists in developing the sleep apnea section of its Web site. ASAA participated in a National Transportation Safety Board hearing, entitled "Medical Oversight of Noncommercial Drivers," held in March 2003.

D. American Academy of Sleep Medicine (AASM)-Dr. Jerry Barrett

Dr. Barrett summarized AASM's 2003 activities. AASM has designed a training program entitled "Sleep Alertness and Fatigue Education in Residency" for ACGME. In April 2003, AASM approved training programs in sleep medicine, and a curriculum will be developed. Applications for programs could be accepted as early as January 2004. Approximately 250 groups will be interested in applying for admission to these programs. AASM and the American Board of Sleep Medicine are working with the American Board of Medical Specialties to design a multidisciplinary, stand-alone examination in sleep medicine sponsored by the American Board of Internal Medicne, the American Board of Pediatrics, and the American Board of Psychiatry and Neurology; the first examination may be administered as early as Fall, 2005. AASM is rewriting the international classification of sleep disorders. In June 2003, AASM administered its first examination for the subspecialty of behavioral sleep medicine. In June 2003, 4,500 persons attended the Associated Professional Sleep Societies Scientific Meeting. AASM and SRS held a sleep research fundraising dinner entitled "Discovering the Secrets of Sleep"; all the money raised at the dinner will be used to support sleep research

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BOARD RESOLUTION: IOM STUDY

The IOM resolution was prepared by the SDRAB subsequent to the meeting and was approved by electronic ballot. A copy of the approved resolution is attached to these Minutes.

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ADJOURNMENT

Dr. Quan thanked the participants and adjourned the meeting at 3:46 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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Background

Dr. Emmanuel Mignot presented an overview of the current status of the field of sleep medicine/sleep disorders research, and described the need for an independent review and assessment of the field by the Institute of Medicine (IOM). Dr. Mignot's presentation emphasized the relevance of sleep medicine to public health, the high prevalence of sleep disorders in the general population and the barriers hindering sleep disorders research and the training of qualified investigators for the field.

Based on the presentation and discussion that followed, the Sleep Disorders Research Advisory Board unanimously approved Dr. Mignot's proposal for an IOM study to provide an independent assessment of the field and make recommendations for improvement of the coordination, efficiency, and effectiveness of sleep research and training of sleep researchers. Sleep research training has also been identified as a major priority in the 2003 National Sleep Disorders Research plan. This resolution has been unanimously approved by the Board concurrent with final approval of the Minutes.

Resolution

Whereas,
The field of sleep medicine is uniquely relevant to public health at all levels of society, and to medicine across multiple specialties.
The field has grown exponentially in the last 10 years.
Sleep disorders such as insomnia, obstructive sleep apnea, restless legs syndrome and narcolepsy are extremely prevalent, affecting at least 30 to 40 million Americans.
Sleep deprivation is increasingly recognized as a major cause of accidents and fatalities and can have deleterious neuroendocrine consequences such as obesity and cognitive impairment.
In contrast to the rapid growth of the clinical discipline, sleep disorders research and sleep research training have lagged behind -- largely because of structural barriers inside academic health centers and elsewhere.
The multidisciplinary nature of sleep disorders research and sleep medicine, together with the critical need for enhanced dissemination of current knowledge and implementation of changes in clinical practice to improve public health, represent major challenges.
Due to the multidisciplinary nature of sleep research and sleep medicine, there are many Institutes and Centers at NIH that have interest in and support sleep related research, and participate in the Trans-NIH Sleep Research Coordinating Committee.

Be it resolved that the Sleep Disorders Research Advisory Board recommends that the National Center on Sleep Disorders Research and the Trans-NIH Sleep Research Coordinating Committee endorse this proposal for an IOM study, and collaborate with NIH and IOM to develop and implement a study that will lead to recommendations for improvement in the coordination, efficiency, and effectiveness of research and research training in sleep and sleep medicine.