NATIONAL CENTER ON SLEEP DISORDERS RESEARCH
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

Sleep Disorders Research Advisory Board Meeting Minutes
June 26, 2002

The 16th meeting of the Sleep Disorders Research Advisory Board (SDRAB) was convened at 8:40 a.m. on Wednesday, June 26, 2002, in the Natcher Conference Center on the campus of the National Institutes of Health (NIH) in Bethesda, Maryland. The meeting adjourned at 3:00 p.m. Dr. Emmanuel Mignot presided as Chair.

TABLE OF CONTENTS

Attendees
Call to Order
Approval of December 5, 2001 Board Meeting Minutes
Report of the NCSDR Director
Sleep Research Update: National Institute of Neurological Disorders and Stroke
Presentation- Metabolic Consequences of Sleep Restriction
Sleep Academic Award Program
Education Subcommittee
Closed Session: Election of Chair for 2002-03
Research Subcommittee Report
New Business
Organization Updates
Adjournment
Certification

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Sleep Disorders Research Advisory Board Page

BOARD MEMBERS PRESENT

Dr. Emmanuel Mignot (Chair)
Dr. Gene D. Block
Dr. Sarah J. Caddick
Dr. Mary Carskadon
Dr. Carol A. Landis
Dr. Stuart F. Quan

EX OFFICIO MEMBERS PRESENT

Dr. Gregory Belenky
Dr. Robert Wolfe Greene
Dr. Carl E. Hunt, Executive Secretary
Dr. Andrew Monjan
Dr. Paul Nichols

LIAISON MEMBERS PRESENT

Dr. Deborah Ader
Dr. Harold Gordon
Dr. Timothy Hayes (for Dr. Israel Lederhendler)
Dr. Karin Helmers
Dr. Nancy Pearson
Dr. Thomas Raslear
Dr. Roger Rosa
Dr. Bette Siegel
Mr. David Wade

FEDERAL EMPLOYEES PRESENT

Mr. Al Golden, NHLBI
Dr. Audrey Penn, NINDS
Ms. Sue Rogus, NHLBI
Ms. Ellen Sommer, NHLBI
Dr. Michael Twery, NHLBI

INVITED GUESTS PRESENT

Dr. Judith Owens
Dr. Eve Van Cauter
Dr. David White

MEMBERS OF THE PUBLIC PRESENT

Ms. Georianna Bell, Restless Legs Syndrome Foundation
Dr. Richard Bootzin, Sleep Research Society
Ms. Christin Engelhardt, American Sleep Apnea Association
Ms. Judith Estrin, Prospect Associates
Mr. James Perlstrom, SSA
Mr. Nathaniel Pobster, HLB Newsletter
Ms. Teresa Wilson, Prospect Associates


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I. CALL TO ORDER - Dr. Emmanuel Mignot

Dr. Emmanuel Mignot, Sleep Disorders Research Advisory Board Chair, called the 16th meeting of the Sleep Disorders Research Advisory Board to order at 8:40 a.m. He welcomed the Board members, members of the public, and others in attendance. Dr. Mignot noted that an important focus of the meeting would be a review of the research plan. Dr. Carl Hunt called attention to the materials in the meeting book, and he asked members to review the statement on confidentiality/ethics issues.

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II. APPROVAL OF DECEMBER 5, 2001 BOARD MEETING MINUTES – Dr. Emmanuel Mignot

Approval of the minutes was moved, seconded and approved unanimously without further discussion.

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

Dr. Hunt reviewed the 11 organizations participating in the Trans-NIH Sleep Research Coordinating Committee (SRCC), including two new members, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Dr. Nancy Pearson of NCCAM and Dr. Deborah Ader of NIAMS join the SDRAB as new liaison members. Ms. Adrienne Oneto is the new representative of the Bureau of the Census as a Liaison Board member. As the new Director of NIH effective May, 2002, Dr. Elias Zerhouni becomes a new Ex Officio member of the SDRAB.

Dr. Hunt reviewed the growth of NIH funding for sleep research, from $72.815 million in 1995 to $145.083 million in 2001. This represents a 99 % growth rate, slightly exceeding the rate for all NIH funding. He also noted the following:

· Research on the relationship of sleep to the metabolic syndrome is part of a $16-million RFA for studies that will focus on the biologic basis of obesity-related cardiovascular disease (CVD).

· A workshop on Cardiovascular Consequences of Sleep-Disordered Breathing (SDB) will be held September 12-13 in Bethesda.

· The NCSDR is preparing a monograph entitled "Sleep and Sleep Disorders in Women," to be published by the American College of Obstetrics and Gynecology in 2003.

Dr. Hunt reported that the Sleep Research Plan Revision Task Force met in December 2001 and April 2002, with the Trans-NIH Sleep Research Coordinating Committee ( SRCC) playing an active role. This was followed by conference calls and participation in an open session of the annual meeting of the Associated Professional Sleep Societies (APSS) in Seattle in June 2002. The latest draft of the research plan (the "June Draft") will be sent to all sleep-related professional societies for their comment and also will be placed on the NCSDR Web site in early July. The deadline for all public comments will be August 23. The Task Force will meet in October to review all comments received and to develop the final draft. After final approval by the Trans-NIH SRCC and SDRAB, the plan will be released by January, 2003.

Dr. Hunt reported that the revised plan provides a comprehensive summary of achievements since 1996, identifies existing gaps, and prioritizes strategies for future programs made possible by new knowledge and technologies. The plan will provide an enhanced focus for research and educational program development for the sleep research community, and will identify new opportunities for interdisciplinary sleep research partners and academic health centers. It will also help the NIH Institutes and Centers and other Federal agencies establish priorities for sleep funding and program development. Other stakeholders include professional and public sleep organizations and the Congress.

Dr. Andrew Monjan suggested that the NCSDR track the number of grants submitted as well as those funded, using information from the IMPACT-2 database. As a potentially useful indicator of the total size of the sleep research pool of investigators, the Sleep Center will explore tracking this parameter on an annual basis.

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IV. SLEEP RESEARCH UPDATE: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) - Dr. Audrey S. Penn

Dr. Audrey Penn, Acting Director, National Institute of Neurological Disorders and Stroke (NINDS), described the Institute's sleep research portfolio of 69 grants (including supplements). The research is supported by 13 funding mechanisms, though 46 of the 69 grants are investigator-initiated R01s. The studies fall in the following areas:

· Basic studies: 5 studies include those on regulation of sleep and arousal, REM sleep mechanisms, dopamine pathways, and hypocretin/orexin.

· Sleep disorders: 9 studies focus on narcolepsy; restless legs syndrome (in the context of peripheral neuropathy, and NINDS intramural studies and protocols); and fatal familial insomnia. Research on neurological disorders influenced by sleep and circadian rhythm includes studies of epilepsy, dementia (in collaboration with the National Institute of Mental Health and the National Institute on Aging), stroke, movement disorders, and multiple sclerosis are also funded.

· Circadian rhythm: 31 studies focus on genetics, regulation entrainment, and plasticity; suprachiasmatic nucleus; and melatonin.

· Instrumentation: 7 studies are devoted to measurement of vigilance, attention, and alertness; evoked potentials and EEG; phototherapy; and magnetoencephalography. Most of this research is part of the Small Business Program.

Dr. Penn also described the NINDS' Specialized Neuroscience Research Programs (SNRP) at minority academic institutions. The goals of the SNRP are to continue the ensure the development of a diverse neuroscience workforce, encourage the interest of potential neuroscientists early in their education, foster research training in minority institutions, and facilitate collaboration between researchers in minority and majority institutions. The SNRP program has awarded 11 grants, including 3 sleep-related studies being conducted at Howard University, the University of Alaska, and the University of Texas at San Antonio.

Dr. Penn said that there is some NINDS research on the relationship between neurological disorders and sleep disorders, but there should be more. The topic of sleep will be discussed at the NINDS Extramural Retreat in 2004. In response to a suggestion that supplements to grants could foster add-on research on sleep, Dr. Penn said that a workshop could be held to explore this idea.

Dr. Hunt stressed the need to study sleep disorders and stroke (e.g., stroke as a complication of untreated sleep apnea). He suggested that NINDS input be included in the Research Plan.

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V. METABOLIC CONSEQUENCES OF SLEEP RESTRICTION - Dr. Eve Van Cauter

Dr. Eve Van Cauter, Professor and Research Associate at the University of Chicago, reviewed several studies examining the impact of sleep on the regulation of metabolism. She noted that the association between hormones and sleep was identified more than 30 years ago when it was reported that adult men secrete growth hormone during the early phase of sleep. Since then, research has indicated a deleterious effect of sleep loss on the endocrine system and glucose modulation.

· One study examined the effect of sleep debt and sleep recovery on hormone concentrations and glucose tolerance (GT) in healthy males ages 18-27. One week of sleep restriction produced dramatic results: a 30 percent slower response to both the GT test and acute insulin response compared with results in rested subjects. Sleep deprivation also raised the 24-hour cortisol profile.

· Another study found that sleep deprivation resulted in 30 percent lower levels of leptin. Amazingly, the effect is similar to that observed with caloric restriction (3,000 calories over 3 days), signaling a negative energy balance. A more recent study examined the effect of 10 vs. 4 hours of sleep on appetite. Subjects who slept 4 hours were always hungry and craved starchy, sweet, and salty foods. These results suggest that sleep deprivation produces a signal mimicking negative energy balance, inducing people to eat and thereby predisposing to obesity. This may have implication for sleep deprivation during sleep apnea as well, creating a vicious cycle in these often already obese patients.

· A study to examine whether chronic sleep restriction is a risk factor for insulin resistance and obesity examined the effect of less than 6.5 hours of sleep vs. 7.5-8.5 hours of sleep in two groups of healthy youth whose sleep habits were monitored. The glucose curves were almost identical in both groups, but the short-sleep group was more insulin-resistant.

Dr. Van Cauter said that these results indicate an association between sleep debt, obesity and diabetes. Sleep deprivation would affect GT and leptin levels and increase the appetite for unhealthy foods. She noted that sleep restriction would have greater impact on obese individuals, who have higher leptin levels to begin with, and on populations such as Mexican Americans and older adults.

During the discussion, Dr. Van Cauter noted that the studies were performed in males only. Because females have higher baseline levels of some hormones (e.g. leptin), sleep restriction might have worse effects in women than in men. An epidemiological study found an inverse relationship between increased body mass index (BMI) and sleep duration in women. There are no data to answer the following questions: Is sleep deprivation related to diabetes and obesity in Native Americans? Are women on oral contraceptives at higher risk of short sleep? Is exercise is a countermeasure to sleep loss? Does insufficient sleep makes compliance to a diet more difficult? All these questions are potentially related to these recent findings.

Dr. Van Cauter also made the following observations: (1) sleep apnea is a risk factor for diabetes while diabetes may be exacerbated by sleep deprivation; 2) the severity of sleep apnea increases with sleep restriction; (3) sleep deprivation may activate the sympathetic system, with cardiovascular impact. (4) sleep debt is generally not paid back fully by weekend sleep. Sleep deprivation may thus play a role in the metabolic syndrome and interact with obstructive sleep apnea.

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VI. SLEEP ACADEMIC AWARD PROGRAM - Dr. Judith Owens

Dr. Judith Owens, Associate Professor of Pediatrics at Brown Medical School, provided an update on the 2001-2002 Sleep Academic Award (SAA) Program. The program, which began in 1995 and will end in 2003, develops curriculum educational resources to advance the knowledge of sleep and sleep disorders in medical schools at all levels, and to enhance the sleep knowledge and skills of faculty and medical professionals.

Dr. Owens reviewed the recent accomplishments of the SAA program in the areas of curriculum and faculty development.

· A collaborative project of the SAA program has produced a model curriculum on Sleep and Chronobiology for medical schools, based on four core competencies and instructional objectives.

· A discussion group on faculty development in sleep education was presented by SAA members at the 2002 Association of Professional Sleep Societies (APSS) meeting in Seattle. The program presented an overview of SAA resources, a model curriculum, and "stealth techniques"-ways to compete for curriculum time in medical school.

· MedSleep-a collaboration between American Academy of Sleep Medicine (AASM) and SAA-develops and distributes SAA educational resources and products free of charge on the AASM website to all interested educators. Educational products available include slide sets, case histories, surveys, curriculum outlines, and a CD with faculty training materials.

· Over 120 "sleep education advocates" have been identified by the SAA program at medical schools across the US and Canada. These individuals advocate at their institutions, network to continue the development and dissemination of educational materials, and provide feedback and evaluation.

· Preliminary results of an AASM Medical School Education Committee survey on the current state of sleep education in medical schools revealed an average increase (from 1.2 hours to 4.1 hours) since 1993 in teaching time for preclinical basic science about sleep. There was also a reported increase in teaching time in sleep medicine for clinical clerkships and in a number of subspecialty fellowship programs. Lack of curriculum time and faculty time were identified as continued obstacles to educational efforts. More data from the survey are expected.

Dr. Owens reported that the "Sleep, Fatigue, and Medical Training: Optimizing Learning and the Patient Care Environment" conference was held in October 2001 and funded by the Agency for Healthcare Research and Quality. The planning of this conference represented the efforts of a number of SAA members. Participants included representatives from AASM, Sleep Research Society (SRS), NCSDR, and the American Medical Association (AMA); a white paper summarizing the conference proceedings is in preparation. Two review articles on the topic of sleep loss and fatigue in medical training that are joint efforts of the SAA group will be published in Sleep and JAMA. In addition, a collaborative focus group/survey study of residents at six SAA sites to assess residents' perception of sleep loss and fatigue and use of alertness management strategies is currently nearing completion. An abstract on this project was presented at the 2002 APSS meeting.

Dr. Owens provided an in-depth look at the SAA program at Northwestern University's School of Medicine, which offers lectures on sleep in years 1 to 4 of training, as well as a summer research in sleep elective, small group sessions, and an elective sleep clinic/laboratory. The residency program offers lectures, case conferences, elective research, fellowships, and mentored clinical research. The principal investigator is a member of the Dean's Council on Medical Education.

Dr. Owens discussed the positive impact of the SAA, quoting from individuals in the program. She noted that attracting young investigators from multiple disciplines and levels increases the visibility and impact of sleep medicine, and it also helps add to the science of sleep.

Dr. Owens made the following recommendations to extend the impact of the SAA:

· Provide funding for career sleep education awards (e.g., 5-year renewable awards), as well as Young Investigator Grants, and other small grant mechanisms to attract new investigators (medical students, residents) and researchers from other fields into sleep.

· Encourage the development of faculty development programs to extend the impact of the SAA program at individual institutions.

· Develop educational outcomes research projects that will identify additional educational needs and provide data on the effectiveness of sleep education programs in changing knowledge, attitudes, and behaviors of physicians in training.

· Develop sleep education curriculae for allied health professions (nursing, pharmacology, clinical psychology).

· Partner with appropriate medical subspecialty groups for development and dissemination of education programs.

· Assess educational intervention outcomes (knowledge, attitudes, behavior) at the continuing medical education (CME) level. In particular, assess the impact of education interventions on the identification of sleep disorders, appropriate management, and quality of life in clinical practice.

Dr. Hunt discussed the possibility of conducting an external evaluation of the SAA program. Dr. Owens suggested that a conference be held to look at successful SAA programs and strategize for continuing the SAA effort. Possible funding mechanisms for continuing collaborative educational projects among the Sleep Academic awardees were discussed, including the AASM Sleep Medical Education Research Fund (SMERF) mechanism.

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VII. EDUCATION SUBCOMMITTEE - Ms. Sue Rogus, Ms. Ellen Sommer

Ms. Sue Rogus provided the following update on NCSDR education activities:

· The NHLBI and CenterNet produced "Sleep Apnea: Is Your Patient at Risk," a continuing medical education (CME) video. CenterNet, a joint program of the Association of Academic Health Centers and Healthcare Management TV, will air the video for more than 1,700 hospitals, and will offer the program for sale through its Web site, as part of its NIH Bench to Bedside continuing education series.

· The Working Group on Sleepiness and Adolescents/Young Adults (ages 13-22 years), co-chaired by the American Academy of Pediatrics (AAP) and the NCSDR, has met twice and is developing two publications for pediatricians. One summarizes the state of the science in sleepiness and adolescents. The second paper is a practical approach to the sleepy adolescent.

· At the upcoming American Academy of Pediatrics (AAP) conference in October 2002 in Boston, members of the Working Group will present a special 2-hour session, "Sleepiness and Adolescents: A Deadly Combination." The NCSDR will also exhibit at the conference, and is exploring a collaborative media activity in conjunction with the Garfield campaign.

· The NCSDR and the NIH's Office of Science Education (OSE)have produced a high school supplementary curriculum on the biology of sleep, sleep disorders, and biological rhythms (currently in press). The curriculum, which has been field-tested, includes a 10-day sleep diary and five classroom lessons. It will be offered free of charge to high school science teachers, and materials will also be available on the OSE Web site. Objectives are to help students understand the importance of sleep to health and the consequences of lack of sleep, to provide experience with the scientific process, and to convey the purpose of scientific research.

Sleep Well. Do Well. Star Sleeper Campaign

Ms. Ellen Sommer reviewed the latest developments with the Sleep Well. Do Well. Star Sleeper Campaign, which features Garfield as its "spokescat" and targets children ages 7-11 - as well as parents, teachers and principals, pediatricians, and school nurses - with messages about the importance of at least nine hours of sleep each night for children to do their best at whatever they do. An active media outreach program was initiated with the launch of the Campaign in February 2001. Activities and products produced since then include a "Back to Sleep Campaign," a television public service announcement (PSA), an "End of Daylight Savings Time Campaign," a matte feature article, a print PSA, and a "New Year's Resolution" audio news release, all of which generated excellent coverage for the Campaign.

In addition, ongoing outreach to selected major media has resulted in coverage in Parents' Magazine, Washington Parents, the CBS Early Show, Sleep Savvy (a magazine of the Better Sleep Council), among other publications, and stories will appear in the Baltimore Sun and Parade Magazine in August. A media event held in a San Antonio elementary school in April, in conjunction with the Annual Conference of the National Association of Elementary School Principals, also received good media coverage.

Upcoming activities include another Back-to School campaign, which will include a contest and winner's event; a media event (similar to one in San Antonio) in conjunction with the AAP conference in Boston; and updating of the Star Sleeper Website homepage. The homepage will contain portals for teachers, parents, and kids. The portal for kids, "Mission Z," will include games and invite visitors to join Garfield and the "Star Sleeper Squad" to carry out a mission.

Partnership Activities

Ms. Rogus reviewed the following activities of several partner organizations in the Garfield campaign.

· The AAP will participate in the October 2002 media event. The NCSDR and AAP are exploring the possibility of jointly producing products for pediatricians.

· The National Association of Elementary School Principals (NAESP) is working with the NCSDR to implement sleep education in schools in selected states.

· The Better Sleep Council (representing bedding manufacturers and retailers) will participate in a joint media outreach effort, and there is a possibility that some members will carry the Garfield doll and "fun pad" in stores.

· The National Association of School Nurses (NASN)is now an official partner in the campaign, and is placing an article about the program in its newsletter to all members. The NASN may participate in the development of sleep educational materials for school nurses.

These organizations communicate with their members through newsletters and Web sites. Several will participate in the NCSDR's Back-to-School campaign.

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VIII CLOSED SESSION: ELECTION OF CHAIR FOR 2002-03 Dr. Mignot/Board

During a closed session, the Advisory Board elected Dr. Stuart Quan as Advisory Board Chair for the year beginning July 1, 2002. Dr. Mary Carskadon was subsequently appointed as the Education Subcommittee Chair for the year beginning July 1, 2002.

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IX RESEARCH SUBCOMMITTEE: SLEEP RESEARCH PLAN REVISION - Dr. David White

The Research Subcommittee had the opportunity to provide input on the 118-page "June draft" of the Revised Research Plan. To begin, Dr. David White, chair of the Sleep Research Plan Revision Task Force, listed the topics in the five main sections of the report: (1) Basic Sleep Science and Methodology, (2) Education and Training (3) Sleep and Health, (4) Restricted Sleep, and (5) Sleep Disorders

Dr. White described how the 14-member Task Force had worked to review the issues, accomplishments, and research priorities and to identify and fill gaps in the draft. At the APSS meeting in Seattle, it was suggested that separate sections be created for manpower issues and for women and sleep. Dr. White said that an executive summary is now in early draft form. It will identify priorities within each section, and the new draft will be circulated to Trans-NIH SRCC and SDRAB members for review.

The June draft (about 125 pages) covers the broad field of sleep problems and disorders, with 5 or 10 pages devoted to each discipline. The target audience is the sleep research community at large, including investigators and scientists involved in program development. The Board engaged in an active discussion with Trans-NIH SRCC members and other attendees regarding suggested refinements to the June draft.

Next Steps

· The Task Force will review all public comments after the August 23, 2002 deadline. There will be 2 conference calls in September, following which the October draft will be prepared. At an October meeting in Bethesda, the final draft will be developed. Advisory Board members are requested to send their comments on the draft to Dr. Hunt or Dr. White via e-mail, including specific suggested language. The final document will be approved by the Trans-NIH SRCC and by the SDRAB, with final acceptance of the revised plan scheduled for the December, 2002 meeting.

Dr. Mignot thanked the Advisory Board for its efforts on behalf of the Research Plan. Dr. Hunt stressed the need for fresh perspectives, noting that all comments will be carefully considered.

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X NEW BUSINESS

Dr. Hunt acknowledged the contributions of the members of the Board who are now completing their 4-year appointments: Dr. Mignot, Dr. James Everett, and Dr. Carol Landis. He presented them with a certificate and letter from NHLBI Director Dr. Claude Lenfant as well as a Garfield doll.

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XI ORGANIZATION REPORTS/UPDATES

Board members were advised that written updates from member organizations could be found in their Program Briefing Books. Several participants provided additional updates of activities of their organizations.

The Narcolepsy Network representative announced that the Network is revising its narcolepsy fact sheet. Christin Engelhardt reported that the American Sleep Apnea Association dramatically expanded the health care professional section of its Web site. She added that a letter to be published in the August issue of American Family Physician advises screening for sleep apnea before surgery.

Dr. Greene reported that the Department of Veterans Affairs (VA) has a total of $9,101,122 in sleep-related research projects during FY 2002. This included $3,239,102 from the VA, $4,588,117 from NIH (including 35% from NIMH, 31% from NHLBI), $404,351 from other Federal sources, $869,552 from external sources.

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XII ADJOURNMENT - Dr. Mignot

Dr. Mignot thanked the participants and adjourned the meeting at 3:00 pm.

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XIII CERTIFICATION

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

Emmanuel Mignot M.D., Chair
Sleep Disorders Research Advisory Board

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

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