NATIONAL CENTER ON SLEEP DISORDERS RESEARCH
LUNG, AND BLOOD INSTITUTE
Sleep Disorders Research Advisory Board Meeting Minutes
June 25, 2003
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
of December, 2002 Advisory Board Meeting Minutes
of the Director NCSDR
Health Initiative: Dr. Jacques Rossouw, WHI Project Officer
and Cancer: Dr. Jeffrey White, National Cancer Institute
of Board Chair for 2003-2004
of Medicine (IOM) Proposal: Dr. Emmanuel Mignot
Board Members Complete Term of Office
Resolution: IOM Study
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
Ms. Sandra McGinnis, Patient Advocate
Dr. Susan Redline, Case
Western Reserve University
Dr. Michael Sateia, Dartmouth Medical
Ms. Dara Spearman, University of Michigan
BOARD MEMBERS ABSENT
Dr. Sarah Caddick, Wadsworth Foundation
Dr. Rafael Pelayo, Stanford
Dr. Clifford Saper, Harvard Medical School
Mr. Phillip L.
EX OFFICIO MEMBERS PRESENT
Dr. Robert Wolfe Greene, University of Texas Southwestern Medical
Dr. Carl E. Hunt, SDRAB Executive Secretary
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
Dr. Daniel Chapman (by phone), Centers for Disease Control and
Dr. Harold Gordon, National Institute on Drug Abuse
Adrienne Oneto, Bureau of the Census
Dr. Thomas Raslear, Department of
Dr. Ellen Witt, National Institute on Alcohol Abuse and
LIAISON MEMBERS ABSENT
Dr. Mary Leveck, National Institute of Nursing Research
Dr. Nancy Pearson,
National Center for Complementary & Alternative Medicine
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
Ellen Sommer, NHLBI
Dr. Samuel Speciale, National Institute on Aging
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
Ms. Pat Britz, National Sleep Foundation
Engelhart, American Sleep Apnea Association
Ms. Joanne Hawana, FDC Reports -
"The Blue Sheet"
Ms. Judy Milton, Sleep Research Society
Ms. Nancy Moy,
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
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
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
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.
- 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
- 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
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
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
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
- 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
- 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
- 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
- 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
> 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
- 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 firstname.lastname@example.org
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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
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
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
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'
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
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
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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A. 2003 National Sleep Disorders Research Plan: Dissemination Plans and
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
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
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
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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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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Dr. Quan thanked the participants and adjourned the meeting at 3:46 p.m.
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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
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ADDENDUM TO MINUTES
SLEEP DISORDERS RESEARCH ADVISORY BOARD
June 25, 2003
INSTITUTE OF MEDICINE RESOLUTION
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.
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.
such as insomnia, obstructive sleep apnea, restless legs syndrome and narcolepsy
are extremely prevalent, affecting at least 30 to 40 million Americans.
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
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.
Last Updated September 2011