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

Sleep Disorders Research Advisory Board Meeting Minutes
April 10, 2000

The twelfth meeting of the Sleep Disorders Research Advisory Board was convened on Monday, April 10, 2000, in Building 45, Natcher Conference Center, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:30 a.m. to adjournment at 4:40 p.m. Dr. David White presided as Chair.

TABLE OF CONTENTS
Attendees
Call to Order and Opening Remarks
Review of Confidentiality and Conflict of Interest Procedures
Report of the Director
Sleep Academic Award
Comments by Director, NHLBI
Education Subcommittee
NINDS Current Plans and Efforts in Sleep Research
Research Subcommittee
Sleep Related Activities In the Department of Transportation
New Business
Future Sleep Disorders Research Advisory Board Meeting
Certification

BOARD MEMBERS PRESENT:
Ms. Carol Bell Anderson
Dr. Mary Carskadon
Robert Greene (ex-officio)
Dr. Carol Landis
Dr. Israel Lederhendler (ex-officio)
Dr. Claude Lenfant
Ms. Sandra McGinnis
Dr. Emmanuel Mignot
Dr. Richard Millman
Dr. Andrew Monjan (ex-officio)
Dr. Michael Rosbash
Dr. Fred Turek
Dr. Michael Twery (ex-officio)
Ms. Carol Walker
Dr. David White
Dr. Marian Willinger (ex-officio)

BOARD MEMBERS ABSENT:
Dr. Gregory Belenky (ex-officio)
Dr. F.J. Brinley, Jr. (ex-officio)
Dr. James Everett, Jr.
Mr. Morris Lyons

FEDERAL EMPLOYEES PRESENT:
Dr. Gerald Fischbach, Director, NINDS
Dr. Timothy Hays, NIMH
Dr. Karin Helmers, NINR
Ms. Mary Lawrence, NCSDR
Dr. Charlotte McCutchen, NINDS
Dr. Thomas Raslear, DoT
Ms. Sue Rogus, NHLBI
Ms. Ellen Sommer, NHLBI
Mr. David Wade, DoC

LIAISON MEMBERS PRESENT:
Dr. Harold Gordon
Dr. Mary Leveck
Dr. Roger Rosa

LIAISON MEMBERS ABSENT:
Dr. Frank Sulzman
Dr. Ellen Witt
Dr. Jesse Blatt
Dr. Daniel Chapman
Dr. Charles Cortinovis
Ms Kathy Creighton
Dr. Sony Sobrian

MEMBERS OF THE PUBLIC PRESENT:
Mr. Robert Balkam, Restless Legs Syndrome (RLS) Found.
Mr. Jerry Barrett, American Academy of Sleep Med. (AASM)
Dr. Robert Basner, American Thoracic Society
Ms. Pat Britz, National Sleep Foundation
Dr. Daniel Buysse, AASM
Mr. Bob Cloud, Narcolepsy Network
Mr. Darrel Drobnich, NSF
Ms. Christin Engelhardt, American Sleep Apnea Assoc.
Mr. Richard Gelula, NSF
Dr. Susan Harding, Sleep Academic Award Program
Ms. Cate Murray, RlLS Foundation
Mr. Nathanial Polster, HLB Newsletter
Ms. Becky Ramsing, Prospect Associates, Inc.
Dr. Susan Redline, Sleep Heart Health Study
Dr. Arthur Strauss, Sleep Disorders Dental Society
Ms. Sue Shero, Prospect Associates, Inc.

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I.     CALL TO ORDER AND OPENING REMARKS - Dr. Michael Twery

Dr. Michael Twery, Acting Director, National Center on Sleep Disorders Research (NCSDR) called the twelfth meeting of the Sleep Disorders Research Advisory Board to order at 8:30 a.m. on April 10, 2000. Dr. Twery informed the Board of Dr. Kiley's promotion to Director, Division of Lung Diseases, National Heart, Lung, and Blood Institute (NHLBI). A search for a replacement was underway, and that he would be Acting Director, NCSDR, during the interim. This change in leadership does not affect the status of the NCSDR within the NHLBI. Board members and Community partners were encouraged to contact him with questions or suggestions related to the Board or NCSDR activities. Dr. Twery reviewed the meeting agenda and the contents of the meeting Briefing Book.

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II.    REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES - Dr. Michael Twery

Dr. Twery presented the policy on confidentiality and avoidance of conflict of interest.

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III.   REPORT OF THE DIRECTOR - Dr. Michael Twery

This report presented a summary of NIH sleep related activities for fiscal year (FY) 1999. Approximately $119 million was awarded by the eight Trans-NIH Institutes and the National Center on Research Resources (NCRR) across the NIH for sleep research in FY99. This represents an increase of about 18% over the 1998 total for sleep related research. The Center also tracks the number and status of sleep applications received across NIH. For 1999, the total number of sleep related applications received across NIH was 269 including 212 new applications. A total of 112 applications, or approximately 41%, were funded, compared to approximately 25% of applications received being funded in 1993. The amount of sleep research funding by the Trans-NIH Institutes and the NCRR has increased approximately 57% between 1993 and 1999. Over the same period, the number of applications received at these Institutes has been sustained at about 230 - 250. Dr. Twery highlighted the relationship of the NCSDR to other NIH Institutes and Federal agencies and sleep education activities. The NCSDR website was launched in January and is accessible from the NHLBI web page. A comprehensive list of sleep related scientific initiatives was reviewed.

New and continuing activities for FY00 included:

Scientific activities: The RFA on Genomic Applications for Heart, Lung, and Blood Research (HL-99-02) had a receipt date of March 14, 2000; RFA on Oxygen Sensing During Intermittent Hypoxia will be released soon; NIH Sleep Training Grant Program (PA-97-064) and Sleep Heart Health Study (SHHS) are still active, including a newly awarded SHHS Coordinating Center (HL-99-014); Nocturnal Asthma, Chronobiology and Sleep RFA (HL-99-011) will be awarded in FY00.

Several meetings have been held or are scheduled for FY00, including: The International Sleep and Breathing Symposium; The NASA Neurolab Symposium; NIAAA Workshop on Sleep and Alcohol; NHLBI/NIA Workshop: Sleep and Host Defense Mechanisms; Society for Neuroscience (SFN) Symposium on the Neurobiological Mechanisms Regulating Sleep, and the Sleep and Circadian Biology DataBlitz; NHLBI Workshop: Research Training and Career Development; National Institute on Neurological Disorders and Stroke(NINDS)/NIH workshop on the Dopamine Connection in Restless Legs Syndrome (RLS), Periodic Limb Movement Disorder, Parkinsonism and Narcolepsy; NHLBI Neurobiology of Sleep and Sleep Apnea Specialized Centers of Research RFA Coordination meeting; and, NHLBI Sleep Academic Award (SAA) RFA Coordination meetings.

Future Activities will include a symposium at the Society for Behavioral Medicine meeting on Sleep Research: New Frontier for Behavior Medicine; American Thoracic Society (ATS) noontime session on the SHHS; a workshop on SAA Faculty Development at the Association of Professional Sleep Societies (APSS) Meeting; and an RFA Coordination Meeting on Obstructive Sleep Apnea in Children.

Collaborative activities: The SFN DataBlitz/mini symposium will have multiple sponsors this year; Presentations/workshops will be held at the annual meeting of ATS, APSS, and SFN; the expert panel report “Drowsy Driving and Automobile Crashes” was developed with the National Highway and Traffic Safety Administration; Workshop recommendations from the NCSDR/NIH National Science Foundation/Center for Biological Timing Workshop “What is Sleep? What is it Good For?” will appear in the April 2000 issue of the Journal of Biological Rhythms; Agency for Healthcare Research and Quality Evidence Based Report on Sleep Apnea Diagnosis; National Research Council/Institute of Medicine Workshop: “Sleep Needs, Patterns, and Difficulties of Youth; NCSDR continues to build and strengthen collaborative activities with professional and voluntary organizations, maintains active and ongoing collaboration with other NIH Institutes, and co-ordinates research activities with the Trans-NIH Sleep Research Coordinating Committee.

Dr. Twery recognized retiring Board members Dr. Fred Turek, Ms. Carol Walker, and Mr. Morris Lyons. On behalf of the NHLBI, NCSDR, and other Board members, he expressed appreciation for their service and contributions to planning sleep programs during their tenure. The Board was invited to send suggestions for the replacement of retiring members.

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IV.    SLEEP ACADEMIC AWARD: PROGRESS AND PLANS FOR LONG-TERM CONTINUATION OF SLEEP EDUCATION INTERVENTIONS IN MEDICAL SCHOOL - Dr. Susan Harding

The SAA Program was initiated in 1996 to improve the quality of sleep medicine education nation- wide. The full program consists of 20 sites, that will meet regularly until 2003 when formal grant support will end. The goals of the SAA program are to encourage curricular development and research in medical school; to increase the knowledge and skills of medical professionals; to develop and evaluate the impact of sleep curricular models that can be adapted and institutionalized by medical schools nationwide; and to promote an institutional environment that encourages appropriate sleep medical care as more is learned about sleep disorders.

Dr. Harding reviewed the accomplishments of selected SAA sites in developing mechanisms to incorporate sleep medicine into the medical school curricula such as increased student contact with patients having sleep disorders; developing sleep related clinical research; examining sleep knowledge and attitudes among physicians and trainees; and increasing program publications on sleep medicine topics.

The SAA program has four working groups to coordinate their efforts in the following areas: Curriculum and Resource Development; Dissemination; Evaluation; and Faculty Development. Each Awardee has a working group primary assignment, but interacts with all group efforts.

The Curriculum and Resource Development Group is working toward the development of a model curriculum in sleep and chronobiology. Currently there is a publication in press in the journal Academic Medicine. Future goals include developing a set of learning objectives for sleep medicine content so that learning objectives will be available for the curriculum model. A key component of the Dissemination Working Group is the Education Resource Development and Dissemination Program, recently named the Medical Education in Sleep (MEDSleep) project. Future goals include disseminating strategies to add sleep topics into the medical school curriculum and developing outreach programs for non physician health care professionals. The Evaluation Working Group is cataloguing the evaluation needs of SAA awardees, such as establishing quality assurance for existing curricular tools; evaluating MEDSleep materials; establishing liaisons with other organizations; and establishing a publications subcommittee.

The Faculty Development Working Group has organized a faculty skills workshop for sleep medicine educators. This workshop was first held at APSS in 1999 and a second workshop is planned for APSS this year. Future goals include developing a mentorship network and holding similar workshops for other professional medical societies.

Dr. Harding discussed how to continue SAA educational programs beyond the time line of grant support for the individual awardees as well as some program wide solutions in addition to MEDSleep such as: developing transferable products, using state of the art technology; appointment of a Sleep Education Committee by the AASM; increasing SAA program visibility with publications; liaisoning with other societies to position educational curricula within courses; increasing sleep medicine topics on Board exams; and incorporating sleep medicine topics in widely used medical textbooks.

SAA awardees are a diverse group representing several professional societies including 6 sleep societies, 6 medical education societies and 15 other medical societies.

The MEDSleep project is a partnership with the American Academy of Sleep Medicine (AASM) to catalogue, evaluate, and disseminate educational products produced by the awardees. Currently, thirty eight products have been catalogued, with 12 of these set for the initial AASM website launch in a variety of formats. A vignette and problem based learning case bank are available including topics on insomnia and sleep disordered breathing, restless legs syndrome, narcolepsy, pediatric sleep topics, insufficient sleep, depression, autonomic dysfunction, and nocturnal angina.

Group discussion after the presentation focused on how these objectives will continue once funding runs out. Dr. Harding noted formation of an AASM Sleep Education Committee and an AASM Sleep Membership section will help insure the longevity of this effort after funding has expired.

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V.     COMMENTS BY DIRECTOR, NHLBI - Dr. Claude Lenfant

Dr. Lenfant addressed questions from the Board regarding the representation of sleep related research among applications received in response to RFA HL-99-024, Genomic Applications for Heart, Lung, and Blood Research; the concept of “piggy backing” studies and maximizing information gathered during longitudinal studies and clinical trials; the continued productive interaction between NHLBI and private Foundations. Such interactions are encouraged, especially in an effort to reduce duplication.

What has historically worked well after funding for an Academic Award program is for professional societies to collaborate with the awardees in ongoing efforts toward achieving the program goals. For the SAA, the intent is that those who received the grants will foster the awareness of the need for sleep in the curricula of their Institutions. The real benefits will come much more from the community than the Institute’s grant.

Dr. Lenfant spoke briefly about the search for a replacement for Dr. Kiley as Director, NCSDR. The vacancy announcement will close May 1. A search committee has been assembled and will convene shortly thereafter. The timing of the appointment of the selected candidate will depend on circumstances of the candidate. Dr. Lenfant thanked Dr. Twery for assuming the position of Acting Director, and also those who have communicated recommendations for members of the search committee and for a new Director for NCSDR. Dr. Lenfant concluded by expressing his appreciation to the outgoing Board members for their service on the Advisory Board.

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VI.    EDUCATION SUBCOMMITTEE

Update of NCSDR Education Activities - Ms. Sue Rogus

Ms. Rogus reported on the restless legs syndrome (RLS) project. The report “Restless Legs Syndrome: Detection and Management in Primary Care” is now complete and has just been printed. Members received a copy of the report in their briefing books. The manuscript has been accepted by American Family Physician and will be published sometime in the next several months. Dissemination of the report will be done through limited direct mail to target audiences, the NCSDR Web site, exhibits, partnership activities, and in response to requests. The RLS Foundation will print its own copies of the report and disseminate it through its existing channels to further the reach of this product.

The NCSDR’s Youth Initiative is a major, long-term project that targets various audiences, including high school students and teachers, and children 7 to 10 years old. The “Awake at the Wheel” materials developed in conjunction with Scholastic, Inc., targeting high school students and teachers, are now on the NCSDR Web site. The supplemental science curriculum, which includes the biology of sleep and its relationship to health, is being developed in conjunction with the NIH Office of Science Education. This component of the project is slated to be completed in the fall of 2001. The youth initiative seeks to focus on children at a younger age (7 to 10 years old) to instill an appreciation of the importance of sleep. The NCSDR has partnered with the Geppetto Group in New York, an agency that specializes in research with children. The Geppetto Group has conducted focus group testing to better understand children’s attitudes about sleep. Based on the focus group results, a preliminary concept was developed. The concept is that getting enough sleep will help you do your best in whatever you do—this relates to both academics and sports. In addition, the NCSDR will be entering into a major 5-year program with PAWS, Inc., that will involve using the character “Garfield” as a sleep “spokescat.” Additional information about the PAWS project will be available at the next board meeting.

The NCSDR Web site was launched recently and includes four main areas: Research, Professional Education, Patient and Public Information, and Communications. The site can be found at www.nhlbi.nih.gov/about/ncsdr.

Future NCSDR Education Activities

Ms. Rogus stated that a possible future activity is the development of a web-based continuing medical education (CME) program. The product would be based on existing NCSDR publications on sleep apnea, insomnia, problem sleepiness, and RLS. A mechanism for including information about narcolepsy in the CME package would be explored.

Dr. Richard Millman, chairman of the education subcommittee, stated that other future topics for consideration include development of a document on medications and sleep, sleep disorders in children, and narcolepsy. He added that outside support is often necessary to address issues. Ms. Rogus stated that defining the scope of some of these potential projects could be problematic. For example, virtually all medications affect sleep in some way, and it would be difficult to narrow the focus sufficiently. Dr. Millman added that sleep disorders in children may also be a problem because numerous topics and disorders could be covered.

Ms. Rogus stated that reaching minority audiences with information about sleep and sleep disorders will need to be a consideration for future activities. The goal of eliminating health disparities is a priority identified by the Department of Health and Human Services. To begin to address the issue of disparities, it is helpful to look at data that are available now. Ms. Rogus asked the partner sleep organizations to reflect on what they have done in the past and suggest possible future activities to reach minority audiences.

Sleep Apnea and Cardiopulmonary Disease in Minority Populations [Dr. Susan Redline]

Dr. Redline, a respiratory epidemiologist, reported on gender and ethnic differences in prevalence rates and risk factors for sleep apnea, especially African Americans. Recognized health concerns among African Americans include hypertension and cardiovascular disease, asthma, and learning and behavioral problems.
Dr. Redline reviewed the impact of obstructive sleep apnea (OSA) on health:

• OSA is a risk factor for cardiovascular disease.
• Asthma may be related to apnea.
• OSA can impair quality of life by causing sleepiness.
• Neurological functions (especially those requiring sustained attention) are impaired.
• Normal growth and development in children may be affected by OSA.

Dr. Redline referred members to an upcoming article in the Journal of the American Medical Association. The citation is: Nieto FJ, Young TB, Lind BK, et al. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. JAMA 2000;283:1829-1836.

A family study in Cleveland with a population that is 50-percent African American showed an overall trend for an increased prevalence of apnea in blacks younger than age 18. The increased prevalence becomes less pronounced with increasing age. The reason for this trend is unknown, but it may be due to survival bias. Data from the Sleep Heart Health Study, which includes more than 6,400 adults from 10 sites with a large population of Native Americans, show an increased prevalence of apnea that corresponds to an increasing body mass index in all groups (whites, African Americans, and Native Americans). Non-obese African Americans are at a higher risk for apnea compared with non-obese whites.

Dr. Redline stated that a question to be examined is whether the severity of OSA is greater in African Americans. Two recent articles have addressed this question. A 1995 study by Ancoli-Israel showed that among 346 elderly African Americans, an apnea-hypopnea index (AHI) of greater than 30 was more common than in whites (odds ratio 2.6; 8 versus 17 percent). In a 1999 study by Stepanski, among 198 children referred for sleep apnea evaluation, African Americans were found to be more hypoxemic (80-percent versus 90-percent saturation). It is not clear whether the disease is more severe in the African American group or whether the children with more severe symptoms were referred.

Risk factors for OSA tend to differ among Caucasians and African Americans. In Caucasians, older age and a small, bony airway (bracheocephaly) are risk factors, whereas younger age and more upper airway soft tissue place African Americans at higher risk for OSA. The genetic modes of transmission also appear to differ among Caucasians and African Americans. Obesity and male gender are risk factors in both groups.

Recent data from a Cleveland cohort of 9-year-old African American children with apnea showed a significant (7mm) increase in systolic blood pressure. Whether the higher blood pressure levels are explained by obesity or apnea is an area of study.

African Americans with an apnea/hypopnea index (AHI) greater than 5 also have significant decrements in quality of life compared with those an AHI less than 5. African Americans with apnea are twice as likely to fall asleep as those without apnea.

Dr. Redline offered the following summary:

• There appears to be an increased prevalence and severity of OSA among young African Americans.
• There is an increased prevalence of severe OSA among older African Americans.
• The impact of the risk factors differs among various population groups.
• Snoring may be under-reported in some groups. (For example, young African American males are the least likely to report/know their snoring habits.)

Dr. Redline briefly discussed treatment issues for minorities with OSA. There are no data that address the efficacy of surgery or oral appliances in minority groups. However, differences can be anticipated due to craniofacial variances. In addition, compliance with continuous positive airway pressure (CPAP) in subgroups is unknown. We need to examine how to optimize adherence accounting for cultural and societal factors. Recognition of OSA in minorities from the patient perspective is limited due to the following:

• Under reporting of snoring among African American men.
• Snoring viewed as a cultural norm.
• The multifactorial nature of sleepiness. (Environmental stresses play a large role.)
• Competing health and social problems. (Sleep disorders may appear relatively insignificant compared with other problems.)
• Limitations of some health insurance programs and poor access to referral centers.

Recognition of OSA may be limited from the physician’s perspective due to the following:

• The need to treat numerous competing health and societal problems.
• Snoring and sleepiness not articulated as problems.
• Lack of awareness among health care professionals about the risk factors for OSA and its association with other health conditions.
• Lack of data on efficacy of tonsillectomy and adherence to CPAP.

Dr. Redline outlined suggestions for further work with sleep apnea in minorities:

• Assess the specific impact of OSA on health and functioning in minority groups and characterize response to treatments.
• Assess the efficacy of and adherence to OSA therapies among minorities.
• Identify cultural and societal issues surrounding sleep apnea and sleep disorders.

Dr. Redline suggested that a good first step would be to address these issues by reviewing existing sleep health promotion materials with an emphasis on cultural and societal sensitivities, identifying which high-risk groups are being targeted (or not targeted), and assessing the receptivity and effectiveness of existing materials. Experience from other programs (such as obesity, hypertension, and asthma) can be examined and piggybacked to programs already in progress.

Discussion and Questions

Dr. Millman asked Dr. Redline to comment on the issue of getting minorities to come in for sleep studies and evaluations. Dr. Redline said that some groups are difficult to reach, but they are generally open to hearing messages. In some cases, it takes a lot of intensive work. A member added that in a veteran’s hospital with a large African American population, a simple step of adjusting CPAP masks to better fit facial structures improved compliance significantly.

In response to a question, Ms. Rogus stated that the NHLBI has specific minority programs and that programs such as asthma, obesity, and high blood pressure also have aspects that focus on minority issues. Dr. Redline added that the Robert Wood Johnson Foundation is also interested in minority issues.

Dr. Millman asked the sleep organizations to report any activities or future ideas to address minority issues. A representative of The American Sleep Apnea Association (ASAA) stated that ASAA focuses on snoring and falling asleep as risk factors for OSA in its publications because the intent is to reach a broad audience. In general, physicians are not looking for sleep apnea in their patients and need basic information rather than information tailored for specific groups. It may also be that physicians who treat minority populations do not attend national meetings where information is distributed. Some materials have been translated into Spanish with funding from the Robert Wood Johnson Foundation. The ASAA is working with corporate sponsors to explore potential funding for minority-related research. Dissemination of information through the Combined Federal Campaign health fairs for Federal employees, which minorities attend, was suggested.

A question was raised about whether other NHLBI programs work with foundations to target minority audiences. Ms. Ellen Sommer replied that the NHLBI is partnering with other organizations in a number of different areas to increase synergy and better utilize information. For example, the NHLBI’s National Asthma Education and Prevention Program funds seven community-based coalitions and plans to fund additional coalitions, as is the Robert Wood Johnson Foundation. The two organizations are working together to explore joint activities to support both sets of coalitions. She also stated that the NHLBI is working with organizations like the SPRY Foundation, which have good community-level networks. Overall, the NHLBI is increasingly working with other groups to get information into communities.

In response to a question about the type of outcome the NHLBI is seeking relative to addressing minority audiences, Ms. Sommer stated that the NHLBI education programs initially focus on creating awareness about an issue in the community and encouraging people to recognize symptoms and get help. So, a central function of the NHLBI education programs is to develop awareness activities for the target audience and complement that with the education of medical professionals.

In response to a question about why it has been difficult to get information to minority audiences, Ms. Sommer stated that the NHLBI’s education efforts are based on the latest science and that only now are there some data on sleep disorders in minorities that provide a base for such efforts. In the future, culturally sensitive activities based on the identified needs of various groups can be addressed.

Dr. Millman stated that the public probably knows more about sleep apnea than physicians do because there is information about it in lay publications. We need to continue to educate the general population and physicians while not ignoring minority populations. Currently, there is little motivation by sleep centers to get sleep materials for minorities.

In response to a question about whether a process exists for selecting the best organization to partner with in targeting minority populations, Ms. Sommer stated that the NHLBI usually looks for an issue area that is not being addressed by other organizations and increasingly is targeting communities at highest risk. Then it looks for partners that can help address the issues in those communities. She added that often the NHLBI is approached by organizations who are interested in doing a variety of activities. In terms of sleep and sleep disorders, the NHLBI is not aware of much current activity directed toward minority audiences, and the NHLBI would like to encourage activity, as well as get involved in this area.

A comment was made that a recent grant solicitation from the Robert Wood Johnson Foundation addresses under served populations and chronic diseases. Dr. Millman noted that the Board must identify future directions before identifying potential partners. We need to know what we want our partners to do.

A member stated that NIH strategic plans are now being refined to identify activities to decrease health disparities. An NIH committee oversees this process. Now is a very appropriate time for this Board to address minority issues. Dr. White stated that Dr. Redline’s idea for a workshop to address sleep disorders in minority populations is a good one. He asked the group how this and other ideas could be operationalized. One answer is that a proposal could be brought to the next Board meeting. Ms. Rogus, Dr. Millman, and Dr. Redline will work on a plan to bring to the Board. Ms. Rogus stated that persons from NHLBI and other institutes will be engaged to find out their experiences in this area. It may be possible to incorporate sleep content into models already in place. A Board member noted that other Institutes are interested in this topic and suggested that plans be made before next fall so that funding can be obtained for next fiscal year.

Dr. Millman recapped the various topics suggested for a future publication:

• Medications and their impact on sleep
• Sleep disorders in children
• A physician’s booklet on narcolepsy

General discussion about these topics followed. The following comments were offered:

• We now know a lot about narcolepsy—it seems that it would be a “do-able” project. On the other hand, a project on drugs and sleep would require much more in terms of process—it is a much larger area.
• The Narcolepsy Network is willing to raise funds to support a narcolepsy project.
• The project on sleep disorders in children would address not only sleep apnea but also sleep needs in children and adolescents. It would take a broad approach to the topic.
• For a pediatric project, we would need to work in partnership with the American Academy of Pediatrics to get the most impact.
• It seems that a narcolepsy project would be faster and shorter term. A project on sleep disorders in children is longer term, with more impact. There would likely be several products needed to support such a broad effort.
• Decisions about priorities need to take into account the science base for the topic, the size of the target audience, and the potential impact on society.
• Dr. White recapped that the next product to be developed would be similar to those already produced by the NCSDR on sleep apnea, insomnia, problem sleepiness, and RLS. It will be a product for physicians and health care professionals rather than patients.
• The narcolepsy project may be able to be completed in a relatively short time frame, allowing planning for a more comprehensive project to take place at the same time.
• A product dealing with children would be the first time this group has dealt with that target audience in this way and would increase diversity.
• The pediatric publication would have to be narrowed to some extent, for example, kindergarten through grade 12 and all the stages in between is a very broad range.
• There was agreement that we now have science on narcolepsy, but there will be a lot more known about pediatric issues in the next year or so.
• A document on children and sleep disorders could include information about narcolepsy without negating the need for a future document on narcolepsy.
• Narcolepsy is a very important topic, but the condition is rare. It is mentioned in the problem sleepiness document. Most primary care physicians would not see narcolepsy as something they will encounter frequently.
• Two areas could be addressed with one document if the piece on children included enough information about narcolepsy. There was general agreement with this concept.
• Ms. Rogus asked for clarification about what topics would be considered for the children’s document. Dr. White stated that for children (K through 12), causes of sleepiness would be the primary issue addressed.
• A caveat needs to be included that says sleepiness manifests differently at different ages.
• Should this document focus only on recognition and not deal with treatment? We may be taking on too much if we address treatment.
• There was agreement that any document needs to be well-focused.

Dr. White asked Board members for a show of hands to indicate support for or opposition to a proposal to produce a document on sleep in children that will focus primarily on sleepiness and include information about narcolepsy. The recommendation was passed for consideration by NHLBI.

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VII.   NINDS CURRENT PLANS AND EFFORTS IN SLEEP RESERCH - Dr. Gerald Fischbach

Dr. Fischbach described the neurodegenerative disorders researched at NINDS which may have important implications for the mechanisms underlying sleep and REM behavioral disorders. In fiscal year 1999, the NINDS sleep related grant portfolio exceeded $15 million.

Dr. Fischbach characterized sleep as an under-studied area, but vital to everyone’s health. The NINDS wants to be more actively involved in sleep research. Sleep disorders may be an early predictor of Parkinson’s disease, and vice versa. Researchers have had their attention directed to very specific circuits of the brain that may lead to periodic limb movement disorders during sleep and perhaps preceding sleep. Sleep has risen to the level of a major concern in neurological and psychiatric disorders of all kinds, and research on these disorders will shed light on normal neurobiological mechanisms underlying sleep.

Dr. Fischbach noted that a new mode of therapy for Parkinson’s disease has been discovered which includes activating a specific brain region (subthalamic nucleus). He predicted that more frequently therapy will be based on altering the electrophysiological activity of the brain, including therapy for debilitating sleep disorders.

In response to an RFA for Deep Brain Stimulation for Parkinson Disease and Other Neurological Disorders, seventy letters of intent and forty complete applications were received by NINDS . These projects will focus on the brain including the role of these pathways in sleep and sleep disorders.

A discussion of sleep as a neurologic state followed Dr. Fischbach’s presentation. Some clinicians feel that sleep disorders may be an early marker of Parkinson’s disease. There is a common element in degenerative disorders such as Parkinson’s and Alzheimer’s; sleep disorders may be central to both of them.

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VIII.  RESEARCH SUBCOMMITTEE

Sleep Recording in Rodents [Dr. Emmanuel Mignot]

Dr. Mignot reviewed potential available sleep recording systems that could be used by those who want to move into studying animal sleep. Currently six or seven systems are in use, including several that are commercially available.

The Board discussed the issues raised by not having a standard for sleep studies in rodents. In recognition of this problem, NINDS issued a contract solicitation last year and an electrophysiological system for rodents is being developed. The need for standardization is illustrated by the difficulty in reviewing data from other labs. The solution may eventually be market driven (i.e., let researchers pick the system they want). The Advisory Board has previously raised this issue and brought together national experts to address the problem. That working group was unable to develop a common solution. The Board decided that listing the current rodent recording systems on the Sleep Research Society/American Academy of Sleep Medicine websites would help facilitate sleep research in rodents.

Enhancing Research on Sleep Deprivation Effects [Dr. Fred Turek]

Dr. Turek led the discussion on “Enhancing Research on Sleep Deprivation Effects” with the question, “What are the health consequences of chronic sleep loss over long periods of time on the various physiological systems?” The discussion centered on how to take advantage of existing clinical trials and epidemiological studies to incorporate sleep related questions without over burdening the patient population. Specific challenges would include researchers with different agendas and ideas choosing their populations; the new challenge of linking basic science to clinical issues; how to get large centers together to discuss the studies already ongoing; how to facilitate the link between epidemiologic studies, clinical trials, and genetics. The challenge left with the Board is how a consortium might be structured to take advantage of clinical data, epidemiological studies, and the molecular genetic revolution, perhaps through high-powered bioinformatics interactions. A centralized bioinformatics organization to handle communication of data as it relates to sleep would be needed. A step-wise progression of bringing together epidemiological, clinical and basic researchers to stimulate the different types of science was suggested.

For example, some of the National Institute on Aging (NIA) longitudinal studies could be primed to introduce sleep into them. A multi-institute supplement program was suggested to allow researchers to get additional polysomnography data. A mechanism that allows for being opportunistic, such as a program announcement, was suggested.

Another challenge will be to get basic molecular advances to influence the clinical and epidemiological questions. A bridge between the genetic level and more clinical level, such as the behavioral neurosciences, to link the operations of genes and gene systems to larger phenomenon, was suggested. The discussion concluded with the decision to take this important issue to discussion by the Trans-NIH Sleep Research Coordinating Committee.

Phenotyping Human Sleep - [Dr. Emmanuel Mignot]

Understanding human sleep and sleep processes through genetic mechanisms was incorporated into the Genomic Applications for Heart, Lung, and Blood Research RFA. The best way to stimulate research in the area would be to use genetic information in epidemiological cohorts or other genetic studies. The idea would again be to add sleep to ongoing general population based studies. Discussion included the problem of different etiologies for the same phenotype.

Insomnia Workshop [Drs. David White, Robert Greene, Daniel Buysse, Mary Carskadon]

The neurobiological basis of insomnia presents an understudied but important area. Recent advances suggest that a workshop is needed to assess current understanding and identify research directions. Clinical as well as basic neuroscience approaches can be taken to the questions raised by insomnia. A basic neuroscience approach would involve some of the new transgenic and gene expression methods as well as newer electrophysiological findings involving new technology and in vitro approaches.

The AASM noted that this is a priority area for their organization that has lagged behind other areas in sleep disorders research. All the development, affective, and cognitive neurosciences can be brought to bear in the study of insomnia. Insomnia treatments would be stimulated by understanding the neurobiology of the condition better. The workshop mechanism is one that will bring together the scientists who will guide further research focused on this clinical problem from the basic perspective.

Potential topics for workshop discussion included the physiological transition from wake to sleep in a normal animal; how sleep is initiated and maintained in a normal animal; and the neurological mechanisms underlying disorders associated with insomnia such as stress or depression.

Future directions - [Dr. David White]

Initiative: Sleep Disorders in Children. Very little is understood in terms of the pathophysiology and consequences of sleep disorders in children. A growing number of people are involved in this research clinically and scientifically. A number of opportunities exist to examine how sleep loss affects behavior and development of children. The Board spoke about the importance of this area and whether the clinical and scientific framework exists in pediatric sleep issues. Data are not available on what sleep is like in children from ages 3 - 10. Developmental growth at that age is a research opportunity. Bringing in other fields, including epidemiological, mental health and non-sleep related expertise would assist in looking at the issues of how sleep provides the scaffolding for behavior and brain development. Data from animal studies are missing in this field.

Initiative: Biomarkers of the Interrelationships Between Sleep and Other Disease Processes. Several questions are crucial to the area of sleep biomarkers: what is the interrelationship between sleep and other disease processes; can sleep be used as a marker in other disease processes; is sleep affecting other diseases and do other diseases affect sleep. This concept embraces the Advisory Board discussions over several years regarding advancing understanding of how sleep deprivation affects general health, and efforts to provide the measurements of how sleep affects disease. Currently it is very difficult to study some of the adverse affects of sleep apnea clinically with the available technology tools. A sleep biomarkers initiative would provide a framework for basic research as well as for potential clinical application, such as inflamation.

This concept is distinct from the National Institute of Nursing Research PA-00-046, Biobehavioral Research for Effective Sleep, which was specifically not for sleep disorders. This concept would be specific to the disease.

Discussion included the personal statement by Board member Carol Walker of the relationship between physical deterioration and sleep disorders; the neurological connection between disease states and how sleep is impacted; the linkage to psychiatric disorders with sleep as a marker and consequence of these disorders. The programmatic challenge is to find avenues and ways linking specific known systems to known circuitry and systems associated with sleep onset and sleep maintenance in a mechanistic way, and to look at causal connections between various disease states and various aspects of sleep. Determining how sleep deprivation affects physiology is a key issue and should be pursued.

National Research Service Award T32-Program Announcement (PA) -Dr. Michael Twery

Dr. Twery noted that the T32 PA funded 4 grants. Continued support for this mechanism was recommended by the Board.

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IX.    Sleep Related Activities In The Department Of Transportation (DoT) - Human Factors Program - Dr. Tom Raslear

Dr. Raslear provided an overview of fatigue research at the DoT including a new initiative on fatigue management. The DoT does research focused on safety rather than biomedical issues with a strong interest in making operators safer and meeting the regulatory needs of government and industry.

At DoT, fatigue research includes the working environment, temperature, vibration, noise, sanitation, workload, information flow; and organizational climate. This fiscal year the Human Factors Coordinating Committee has produced a plan for operator fatigue management policy that will be funded by the various DoT components. This initiative is designed to develop a knowledge base to formulate strategies, tools, and technologies to forecast, detect, and pro-actively manage fatigue.

Phase 1 of this initiative will involve compiling a fatigue management resource on the best practices of fatigue management, including a consensus of experts, technology developers, and an initial assessment of promising approaches as determined by performance markers. A broad agency announcement will go out at the same time; its purpose is to foster partnerships and promote technology development including performance markers.

Phase 2 will run for four or more years, resulting in the second edition of the fatigue management resource and progress on a fatigue management analytical system.

Human factor representatives from each of the DoT modes will be available to speak about their programs at future Board meetings.

Discussion followed regarding engaging the sleep community and sleep researchers in DoT’s efforts. The Board will continue to follow DoT’s plan for operator fatigue management policy. The funds for this project will come from the Office of the Secretary of Transportation and each DoT component. Evaluation of the fatigue management plan will be part of the DoT initiative.

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X.     NEW BUSINESS - All

Board members expressed concern regarding potential decreases in the Department of Defense (DoD) commitment to sleep-related research. Board members requested that a DoD representative attend the next meeting to discuss an overview of DoD sleep related research.

In his closing comments, Dr. Twery reminded the Board that the NCSDR welcomes suggestions for potential candidates to replace retiring Board members.

The meeting was adjourned at 4:40p.m.

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XI. FUTURE SLEEP DISORDERS RESEARCH ADVISORY BOARD MEETINGS

2000                                                                                                                    2001
Wednesday, December 6                                                                                    Tuesday, June 26
                                                   January 2002 (Date To Be Announced)

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XII.    CERTIFICATION

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

David P.White,Chair
Sleep Disorders Research Advisory Board

Michael Twery, Ph.D.
Acting Exective Secretary
Sleep Disorders Research Advisory Board

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