NATIONAL CENTER ON SLEEP DISORDERS
RESEARCH NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Sleep Disorders Research Advisory
Board Meeting Minutes December 11, 2002
The 17th meeting of the Sleep Disorders Research
Advisory Board (SDRAB) was convened at 8:45 a.m. on Wednesday, December 11,
2002, in the Natcher Conference Center on the campus of the National Institutes
of Health (NIH) in Bethesda, Maryland. The meeting was adjourned at 3:30 p.m.
Stuart Quan, MD, presided as Chair TABLE OF
CONTENTS
Attendees Opening Comments Adoption of
June, 2002 Advisory Board Meeting Minutes Introduction of New Members Report of the Director NCSDR National Children's Study: Dr. Tamar Lasky, National Institute of
Child Health and Human Development Workshop
Report - Cardiovascular Consequences of Sleep-Disordered Breathing: Dr. Stuart
Quan Education Subcommittee
2003 Revised National Sleep Disorders Research
Plan New Agenda Item Public Reports Adjournment Certification
NCSDR Home
Page
Sleep Disorders
Research Advisory Board Page
BOARD MEMBERS PRESENT
Dr. Stuart F. Quan (Chair) Dr. Mary Carskadon
Dr. Kathryn Lee Ms. Sandra McGinnis Dr. Rafael Pelayo Dr. Susan
Redline Dr. Michael Sateia
EX OFFICIO MEMBERS PRESENT
Dr. Carl E. Hunt, SDRAB Executive Secretary Dr.
Timothy Hays (for Dr. Israel Lederhendler) Dr. Paul Nichols
LIAISON MEMBERS PRESENT
Dr. Deborah Ader Dr. Harold Gordon Dr. Nancy
Pearson Dr. Christopher Platt Dr. Thomas Raslear Dr. Roger Rosa
Dr. George Ruby Dr. Ellen Witt
FEDERAL EMPLOYEES PRESENT
Ms. Pamela Anikeeff, NHTSA Mr. Al Golden,
NHLBI Ms. Sue Rogus, NHLBI Ms. Susan Sagusti, NHLBI Ms. Ellen
Sommer, NHLBI Dr. Michael Twery, NHLBI
INVITED GUESTS PRESENT
Dr. Tamar Lasky, NICHD Dr. David White (present
by phone)
MEMBERS OF THE PUBLIC PRESENT
Robert Balkan, Restless Legs Syndrome Foundation
Jerome Barrett, American Academy of Sleep Medicine Pat Britz, National
Sleep Foundation Darrel Drobnich, National Sleep Foundation Christin
Engelhart, American Sleep Apnea Association Richard Gelula, National Sleep
Foundation Carey Pulvino, American Academy of Sleep Medicine Judy Yore,
Sleep Research Society
Return to Table of Contents
I. OPENING COMMENTS - Dr.
Stuart Quan Dr. Stuart Quan, Sleep Disorders Research Advisory
Board (SDRAB) Chair, welcomed the Board members, members of the public, and
others in attendance. Dr. Quan noted that an important focus of the meeting
would be review of and vote on the revised National Sleep Disorders 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.
Return to Table of Contents
II. ADOPTION OF MINUTES
FROM JUNE 26, 2002, MEETING - Dr. Stuart Quan
Approval of the minutes of the June 26, 20002 SDRAB
meeting was moved, seconded, and approved unanimously without further
discussion.
Return to Table of Contents
III. INTRODUCTION OF NEW
MEMBERS
Dr. Hunt announced that two members will be leaving
the Trans NIH Sleep Research Coordinating Committee (SRCC). Dr. Paul Nichols,
NINDS, will be replaced by Dr. Merrill Mitler, and Dr. Karin Helmers, NINR,
will be replaced by Dr. Mary Leveck.
Dr. Hunt also introduced the four new members
appointed to the SDRAB effective July 1, 2002:
- Dr. Kathryn Lee, a Professor of Family Health Care
Nursing at the University of California School of Nursing, whose specialty is
sleep disruption and disorders in women
- Dr. Rafael Pelayo, an Assistant Professor in the
Department of Psychiatry and Behavioral Science from Stanford University, a
Sleep Medicine physician who has a special interest in educating health care
workers and the general public about sleep, as well as pediatric sleep
disorders.
- Dr. Susan Redline, Chief of the Division of
Clinical Epidemiology at Rainbow Babies and Children's Hospital, Department of
Pediatrics, Case Western Reserve University, who is a Sleep Medicine physician
with a research focus on the genetic epidemiology of sleep disordered breathing
- Dr. Michael J. Sateia, Professor of Psychiatry and
Director, Section of Sleep Medicine at Dartmouth-Hitchcock Medical Center,
whose research interests include insomnia and its pharmacotherapy, alertness
monitoring, and sleep curriculum development.
Dr. Hunt also announced two new Liaison Members of
the SDRAB:
- Dr. Christopher Platt, Neuroscience Program
Director, National Science Foundation
- Dr. George Ruby, Acting Director of Occupational
Medicine, Occupational Safety and Health Administration, U.S. Department of
Labor.
Return to Table of Contents
IV. REPORT OF THE DIRECTOR,
NCSDR Dr. Carl E. Hunt
Dr. Hunt updated members on the National Center for
Sleep Disorders Research (NCSDR) web site,
www.nhlbi.nih.gov/sleep. He also
introduced a new member of the NCSDR administrative staff, Ms. Pamela Palmer.
Dr. Hunt reported that NIH Sleep Research Funding has
doubled from 1995 ($72,815,000) to 2001 ($145,085,000). There is, however,
still substantial opportunity for growth.
Dr. Hunt discussed a new NHLBI/NIA RFA on the role of
sleep disordered breathing (SDB) in metabolic syndrome, whose goal is to
elucidate the relationships between SDB and obesity, hypertension,
dyslipidemia, insulin resistance, and vascular inflammation. Applications are
due by February 11, 2003. Other RFAs potentially related to sleep research were
available in the Board briefing book, including a request for information on
developing and applying nanoscience and nanotechnology to heart, lung, blood,
and sleep disorders (due January 24, 2003).
Dr. Hunt responded to a previous request by Board
members to provide reports from recent workshops on sleep issues (available in
the Board briefing book). These included "The CVD Consequences of Sleep
Disordered Breathing (draft);" "RLS: Diagnosis and Diagnostic and Epidemiologic
Tools;" "Neurobiology of Sleep and Waking: Implications for Insomnia" (the
report for which is on the NCSDR web site); "Sleep, Fatigue and Medical
Training: Optimizing Learning and the Patient Care Environment" (which will be
published in Sleep, March, 2003); and "Cardiovascular and Sleep Related
Consequences of TMJ Disorders" (the report for which is on the NCSDR web site).
Future meetings of potential interest to the Board (available in the Board
briefing book) include the NCSDR-sponsored "Effects of Sleep Disorders and
Sleep Restriction on Adherence to CVD Treatment Recommendations" (March 12-13,
2003).
Dr. Hunt reported on several other activities
sponsored by NCSDR. A monograph on sleep and sleep disorders in women will be
published in 2003 in an American College of Obstetrics and Gynecology
monograph. The NCSDR bookmark is being revised to include up-to-date
information about NCSDR programs and contact resources.
Dr. Hunt concluded by reviewing the process leading
to the final draft of the 2003 Revised National Sleep Disorders Research Plan
(see VIII below). This included creating a 14-member research task force,
developing a draft, active participation by the Trans-NIH Sleep Research
Coordinating Committee, and obtaining public comments at national sleep
research meetings and from posting the draft plan on the NCSDR web site for 2
months.
Return to Table of Contents
V. NATIONAL CHILDREN'S
STUDY - Dr. Tamar Lasky, National Institute of Child Health and Human
Development (NICHD)
Dr. Tamar Lasky presented the National Children's
Study (NCS), a 21-year prospective cohort longitudinal study of 100,000 people
whose goal is to determine the basic mechanisms, interrelationships, and
effects of chemical, physical, behavioral, and socio-cultural environmental
factors on child health and development. This national study is sponsored by
NICHD, the Centers for Disease Control and Prevention, the National Institute
of Environmental Health Sciences, and the Environmental Protection Agency. The
study is designed to identify safe/dangerous exposure levels and attribute
causality for child health risks. NCS study subjects will include children and
their families, possibly beginning with enrollment of women prior to or at
least during pregnancy.
Priority areas of focus of the NCS will include the
impact of environmental exposures on birth defects, fetal growth,
neurobehavioral and neurocognitive development, physical growth, injury,
asthma, and obesity. Key measures anticipated are environmental samples,
biomarkers for chemical exposures, and personal interviews/histories.
NCS will have multiple enrollment sites across the
U.S. The planning process includes large-scale collaboration mediated by an
interagency coordinating committee, a federal advisory committee and 22 working
groups, each comprised of 10-20 federal and non-federal scientists. The initial
authorization for the project was $18 million, with additional funding to be
appropriated over time. NCS planners are currently developing methodologies and
pilot studies for the initiative, with enrollment scheduled to begin in 2005.
The study web site, http://NationalChildrensStudy.gov,
is already posting useful information, such as a database of biomarkers for
chemical exposures and outcomes.
Dr. Carl Hunt and Dr. Mary Carskadon are members of
the Development & Behavior Working Group and have developed a 2-page draft
of a core hypothesis for the NCS related sleep problems and disorders in
children. It is important to that information on sleep be collected because
sleep affects so many study variables, such as injury, development, and
metabolic outcomes.
Several Board members expressed the opinion that
sleep should be a core priority, since more children are likely to have sleep
deprivation than other environmental risks, such as lead exposure. Members
suggested a variety of ways that sleep could be included in the study as it
interrelates with other priorities as an exposure or an outcome, such as:
-Sleep disorders as an early indicator, correlate, or
outcome of attention deficit hyperactivity disorder (ADHD). -SDB and asthma
in childhood. -Prematurity and the increased the risk of childhood sleep
apnea. -The effects of various childhood exposures on development of sleep
apnea. -Cultural issues, such as the impact of co-sleeping. -Sleep
problems in under-served, under-represented populations. -Ethnic minorities
and sleep apnea.
In addition, Board members noted that just asking how
much sleep a participant gets during the interview would provide critical
information. Discussion also included the need to develop easy, inexpensive,
and reliable tools to measure sleep disturbances in children. The next step
will be to develop a core content of sleep-related information that will need
to be collected in all enrollees at to-be-determined intervals. Advisory Board
members are encouraged to provide input to Drs. Carskadon and Hunt to assist in
developing the sleep-related core content for the study design.
Return to Table of Contents
VI. WORKSHOP REPORT:
Cardiovascular Consequences of Sleep-Disordered Breathing - Dr. Stuart Quan
Sleep Disorders Research Advisory Board Chair Dr.
Stuart Quan reported on the September 2002 workshop sponsored by NCSDR and
NHLBI related to the CVD consequences of SDB. Key points include the following.
- SDB increases the risk of hypertension; the higher
a patient's score on the apnea-hypopnea index by quartile, the higher the risk.
Possible mechanisms are increased sympathetic activation and endothelial
dysfunction. Increased levels of endothelin, a vasoconstrictor peptide, have
been found in patients with SDB. Some studies have also found diminished
endothelial cell production of nitric oxide, a vasodilator. Intermittent
hypoxia and sleep deprivation may each promote production of pro-inflammatory
cytokines that impair endothelial function.
- SDB is associated with an increased prevalence of
cardiovascular disease (CVD) (including hypertension, myocardial infarction,
stroke, and congestive heart failure). The risk factors for SDB and CVD are
highly interrelated. For example, obesity is a major risk factor for SDB,
hypertension, and CVD. Sleep deprivation caused by SDB appears to contribute to
the development of insulin resistance and may be a risk factor for obesity.
Obesity and SDB may interact to produce CVD, possibly through the secretion of
adipokines. Inflammation also appears to play a role in the pathogenesis of
CVD. Emerging evidence suggests that the intermittent hypoxia caused by SDB may
trigger an inflammatory response and the release of substances implicated in
coronary heart disease.
- Important future research priorities include 1)
prospective epidemiological studies to elaborate the relationship among
inflammatory biomarkers and hypertension and SDB; and 2) studies to understand
the role and mechanisms of the sympathetic nervous system, to disentangle the
complex interactions of SDB and diverse CVD risk factors, to identify
subpopulations at special risk, and to develop non-invasive biomarkers of
vascular disease that could be useful both for diagnostic and for treatment
studies in order to assess the role of SDB as a risk factor for CVD and the
impact of therapy..
- SDB has been associated with hypercoagulability,
and patients with pulmonary embolism or deep vein thrombosis have a higher
incidence of SDB. While some studies have observed enhanced platelet adhesion
and aggregation with SDB, larger, well-controlled studies of SDB and hemostasis
are needed to define the relationship and mechanisms of action and, ultimately,
determine whether patients with SDB should be treated for hypercoagulability.
- SDB is common in patients with heart failure.
Epidemiological research is needed on the prevalence of SDB in those with
asymptomatic heart disease, as well as additional studies on the impact of SDB
on heart failure and the impact of treating sleep apnea on cardiac function. -
While cardiac arrhythmias are seen in some patients with SDB, better studies
are needed regarding incidence and prevalence and to determine: 1) whether an
independent association exists between arrhythmias and SDB or if they are
simply a sign of underlying heart disease; and 2) whether arrhythmias occurring
during SDB have prognostic value.
- Additional study of gene-environment interactions
is needed to better characterize the obstructive sleep apnea (OSA)/SDB/CVD
phenotype. An important step would be to include SDB assessment in CVD
epidemiological studies. Research is also needed to identify genes common to
SDB and CVD and to determine whether SDB patients with different genetic
backgrounds have differing susceptibility to CVD.
The workshop participants concluded that basic
research and animal studies of underlying mechanisms were needed to answer the
critical research questions. To carry out the epidemiologic research suggested,
it will first be necessary to develop simpler screening tools than today's
polysomnograms. Participants also agreed that major clinical intervention
trials were not warranted until SDB phenotypes, causal mechanisms, and
effective, well-tolerated therapies became available.
Return to Table of Contents
VII. EDUCATION
SUBCOMMITTEE - Ms. Sue Rogus, Ms. Ellen Sommer
The Sleep Well. Do Well. Star Sleeper Campaign
Ms. Ellen Sommer updated the Board on the Sleep Well.
Do Well. Star Sleeper campaign, which features Garfield as its "spokescat."
Targeting children ages 7-11 as well as parents, teachers and principals,
pediatricians, and school nurses, the campaign promotes at least nine hours of
sleep a night for children to do their best in all endeavors.
In 2002, promotions included an audio news release
suggesting getting nine hours of sleep a night as a New Year's resolution for
children, a media event with third graders in San Antonio, another media event
in connection with the American Academy of Pediatrics meeting in Boston, and a
second "back to school" campaign.
In addition, 1,100 second and third graders
participated in the "How I Get a Heap of Sleep" contest, sending in three ways
they get a good night's sleep. The contest included tested classroom activities
that reached one million children.
The campaign's web site
http://www.nhlbi.nih.gov/health/public/sleep/starslp/
also continues to evolve, now featuring interactive games with sleep messages,
such as a create your own Garfield comic and "Mission Z" in which children work
to turn off alien sound waves that disturb sleep. Millions of visits to the
site have been recorded, and thousands of links to the site appear on search
engines and related web pages. A separate portal for teachers contains
activities and lesson plans, and portals also exist for parents and
pediatricians with relevant information and tips.
Board members raised the possibility of having the
site (or a related CD) available in pediatricians' offices and asked whether
any outcome evaluation has been developed yet. Ms. Sommer explained that media
exposure and other process evaluation data were easy to obtain. However, an
outcome evaluation that would survey users regarding knowledge or behaviors was
complicated by the need for Office of Management and Budget clearance and would
be expensive. The group discussed using an RFA to conduct evaluation and
getting the sleep community to help. In response to questions, Ms. Sommer noted
that the site does not contain links to medical help for sleep disorders,
although it does link to the NCSDR site. She also reported that testing has
shown that children are very familiar with Garfield, view him positively, and
believe him, and that he also has strong appeal for adults.
Ms. Rogus reported that the American Academy of
Pediatrics, the National Association of School Principals, the National
Association of School Nurses, and various elementary schools are important
partners in the Garfield campaign. The Duluth, Michigan, public schools served
as a prototype and tested the campaign materials. All schools can download the
materials from the campaign web site. Other Educational Activities
The high school curriculum on the biology of sleep,
sleep disorders, and biological rhythms, discussed at the June, 2002, Board
meeting, will soon appear on the NHLBI and NIH Office of Scientific Education's
web sites. The curriculum is also being presented at the 2003 meeting of the
National Science Teacher's Association.
A sub-panel of the Working Group on Sleepiness and
Adolescents (ages 13-22) presented a two-hour session at the annual meeting of
the American Academy of Pediatrics. The Group is also developing two papers for
submission to the Pediatrics on the state of the science and on clinical
approaches to sleepy adolescents.
Future educational activities will include enhanced
promotion of the Garfield campaign, revising the narcolepsy fact sheet, and
disseminating the high school curriculum and Working Group papers.
Ms. Rogus also noted that partner groups helped with
educational activities beyond the Garfield campaign, including examples such as
Jordan's Furniture Stores, which handed out sleep materials with children's
bedding; Sweet Dreamzzz in Detroit, a group of volunteer mothers; and the
Better Sleep Council, which has been working with the bedding industry. Board
members suggested that sleep advocates, family physicians, and nurse
practitioners might also be appropriate educational partners.
Dr. Quan asked Ms. Rogus to report back to the Board
on the issue of snoring toys, which Dr. Pelayo described as sending the
incorrect message that snoring is funny, rather than a potential health
concern. Dr. Pelayo will contribute background information.
Return to Table of Contents
VIII. 2003 REVISED
NATIONAL SLEEP DISORDERS RESEARCH PLAN - Dr. David White, Dr. Stuart Quan, and
Board Members
Dr. David White, Chair of the Task Force that
developed the 2003 Revised Sleep Research Plan, provided an overview of the
Plan, which features 30 scientific sections with background information,
progress since the 1996 Research Plan, and future research recommendations. He
reviewed the research recommendations highlighted in the Executive Summary,
including the following:
1. An improved understanding of all aspects of the
neurobiology and functions of sleep;
2. Enhanced understanding of the impact of reduced or
restricted sleep on both behavior and neurobiologic and physiologic functions
across the entire age spectrum;
3. Improved understanding of the processes that lead
to specific sleep disorders-the most important of these are insomnia, restless
legs syndrome, sleep apnea and disorders of ventilatory control, and primary
disorders of hypersomnolence;
4. Careful assessment of the normal human sleep
phenotypes and the normal range of variation;
5. Development of new treatments for sleep disorders,
with comprehensive outcome evaluation and appropriately-powered clinical trials
leading to clinical management guidelines for the following disorders, which
represent the greatest needs and opportunities: adult and pediatric obstructive
sleep apnea, insomnia, narcolepsy and restless legs syndrome;
6. How sleep affects, and is affected by, a variety
of disease processes, including medical conditions, neurologic disorders,
psychiatric, alcohol and substance abuse, and pediatric genetic and
neurodevelopmental disorders;
7. Development of sleep educational programs for
health professionals and the public;
8. Greater application of new technologies and
methodologies to sleep research and patient management;
9. Expanding research training, which is essential to
expanding sleep research.
Plan Approved, with Revisions
The Task Force was complimented by the Advisory Board
for creating a balanced, logically flowing document responsive to the needs of
the sleep community. The Board unanimously approved the Research Plan with the
understanding that the minor modifications recommended by the Board will be
made by the NCSDR.
Implementation of Revised Research Plan
Following final editing by NCSDR staff, the Research
Plan will go to Dr. Lenfant, Director of NHLBI, and Dr. Zerhouni, Director of
NIH, for their review and approval. The final document will be posted on the
NCSDR web site, with printed copies available thereafter. Discussions are in
process regarding possible publication of the Executive Summary in the journal
Sleep and perhaps other scientific journals.
The Advisory Board discussed recommendations for
implementing the Plan. Suggestions included:
1. Selecting one or two topics and bringing in
experts to future meetings to advise the Board on implementation strategies;
2. Relying on the Board's own expertise to making
recommendations; or
3. A combination of the above. Members expressed
concerns about making decisions too quickly or focusing too narrowly,
especially in light of the opportunities for cross-disciplinary activities.
To take the first step in implementation of the Plan,
the Advisory Board addressed the need to develop novel tools for assessing
sleep and measuring sleep-related exposures and outcomes methods and for
assessing sleepiness in large studies. Sensitive, specific, and reliable tools
are needed to determine the function of sleep and to measure the physiologic
processes leading to sleep deprivation.
The Board also made the following suggestions for
other priority topics for implementation:
- Relationship of learning, memory, and sleep. -
Sleep and the development of neurocognitive function from childhood through
adulthood.
Return to Table of Contents
IX. NEW AGENDA ITEM: WHERE
ARE SLEEP GRANTS REVIEWED?
Dr. Quan reported that Dr. Allan Pack has requested
that the Advisory Board collect information on where NIH sleep research
applications are reviewed, and how this process might be altered by further
reorganization of study sections. For example, Dr. Pack said that the pulmonary
section does not currently review proposals related to SDB. Dr. Hunt agreed to
investigate this issue and report back to Dr. Quan and the Board.
Return to Table of Contents
X. PUBLIC REPORTS AND
OTHER COMMENTS
Several organization representatives reported on
recent activities. Written reports submitted were available to Board members in
their meeting materials
Mr. Jerome Barrett from the American Academy of Sleep
Medicine advised the Board that the Academy has relocated to Chicago. Many
staff are new, including Carey Pulvino, who handles the Sleep Medicine
Education and Research Foundation, and Judith Yore, who will work with the
Sleep Research Society (SRS). Recent Academy activities include working on
Sleep Medicine certification by the American Board of Medical Specialties and
development of an ACGME approved fellowship program in Sleep Medicine.
Mr. Bob Balkan from the Restless Legs Syndrome
Foundation updated the Board on a May workshop held at NIH on RLS diagnostic
and epidemiologic tools. In addition, the Foundation launched a database of
health care providers with expertise in RLS on its web site and recently held
its first national RLS patient meeting.
Ms. Christin Engelhardt, Executive Director of the
American Sleep Apnea Association, reported on public education activities
including the involvement of actor George Kennedy as a spokesperson. The
Association also is working with the American Society of Anesthesiologists on
pre- and post-surgery guidelines for sleep apnea.
Mr. Richard Gelula, Executive Director of the
National Sleep Foundation (NSF), reported on the recent national summit on
drowsy driving, and on new pediatric sleep guidelines. In March, 2003, NSF and
the National Institute on Aging will sponsor a Congress on Sleep, Health and
Aging. NCSDR is also a co-sponsor for this conference. Aging will an important
focus for National Sleep Awareness Week (March 31-April 6, 2003).
Return to Table of Contents
XI.
ADJOURNMENT
Dr. Quan thanked the participants and adjourned the
meeting at 3:15 PM.
Return to Table of Contents
XII. 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
Return to Table of Contents
|