PA-00-046: BIOBEHAVIORAL RESEARCH FOR EFFECTIVE SLEEP

Department of Health
and Human Services (HHS)

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BIOBEHAVIORAL RESEARCH FOR EFFECTIVE SLEEP Release Date: January 19, 2000 PA NUMBER: PA-00-046 National Institute of Nursing Research National Heart, Lung, and Blood Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Mental Health National Cancer Institute THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Institute of Nursing Research (NINR), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), and the National Cancer Institute (NCI) invite applications to investigate sleep deprivation in health and illness. The goal of this program announcement is to stimulate clinical and applied research on behavioral, psychosocial and physiological consequences of acute and chronic partial sleep deprivation in either chronically ill or healthy individuals and to develop environmental, clinical management, and other interventions with the potential to reduce sleep disturbances and significantly improve the health of large numbers of people. Although sleep disorders are a cause of sleep loss in affected individuals, the questions to be addressed under this solicitation should focus on causes and consequences of sleep deprivation, apart from any sleep pathology. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Biobehavioral Research for Effective Sleep, is related to the priority areas of health promotion and disease prevention. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being utilized by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm RESEARCH OBJECTIVES Background Inadequate sleep or nonrestorative sleep has major implications for public health, safety, productivity, and well-being. It has been estimated that more than 60 million Americans, or approximately one in three adults, experience inadequate sleep that can interfere with daily activities. In fact, the report of the National Commission on Sleep Disorders Research concluded that inadequate sleep is such a pervasive problem that it appears to be accepted as a normal part of life. Excessive sleepiness has been associated with accidents at work or at home, and at least three percent of serious automobile accidents and fatalities are due to a fatigued driver. Accidents occurring as a result of sleep deprivation have major implications for public health and safety. In addition, partial and chronic sleep deprivation adversely affects individual job performance and quality of life. The NIH National Sleep Disorders Research Plan identified research needed in basic, clinical and applied areas. The basic and clinical areas of research have been the focus of other initiatives. The current program announcement focuses on the applied research areas, the sleep-related problems found in healthy and chronically ill individuals who have acute and chronic partial sleep deprivation. Partial chronic sleep deprivation in healthy individuals is primarily due to external demands as found in shift workers, medical students, nurses and working parents. In addition, sleep deprivation may be due to lifestyle choices as made by teens and young adults. Little is known about the consequences of sleep deprivation on quality of life and measures of behavioral, cognitive and psychosocial function. There are many chronic health conditions that interfere with sleep. Sleep disturbances are associated with Alzheimer’s Disease and other dementias, rheumatoid arthritis, fibromyalgia, AIDS, cancer, neurodegenerative disorders, chronic obstructive pulmonary disease, asthma, cardiovascular disease, urinary incontinence, drug abuse (as well as withdrawal from drug abuse) and chronic alcoholism. Sleep deprivation can be exacerbated by pain and by environmental conditions associated with hospitalization and home care that are not conducive to restorative sleep. Sleep deprivation can also increase the risk of depression in chronically ill individuals. Research is needed on sleep deprivation associated with medical disorders, and their link to other mental disorders, symptoms, and related disabilities. Little is known about sleep deprivation in children. A vast majority of children complain about feeling tired during the day and 15 percent of children have reported falling asleep during school at least once. Acute and chronic partial sleep deprivation in children has been associated with decreased cognitive functioning and school performance. Sleep deprivation may also be a risk factor for poor behavioral adjustment and behavioral problems such as attention deficit disorder. The potential consequences of sleep deprivation on behavior and growth across the different stages of development has not been well characterized. It has been estimated that over half of the 33 million adults over 65 years of age have some chronic sleep complaint which contributes to personal discomfort and illness, to caregiver burden, and to overall health care costs. Elderly individuals without sleep disorders may experience sleep disruption due to factors associated with the institutional care environment and/or poor sleep hygiene practices. The etiology of sleep deprivation (i.e., shift work, environmental conditions, lifestyle, chronic illness, medical treatment related effects) needs to be determined and specific at-risk populations with adverse health consequences need to be identified, apart from sleep disorders. Research is also needed to identify interventions (e.g., light therapy, behavioral interventions) to improve the quality of sleep in healthy and chronically ill individuals. Treatment approaches using sleep deprivation or phase shifting as an intervention for mental disorders in patients of any age is also an area of interest. Listed below are examples of studies that would be responsive to this program announcement. However, these are only illustrative examples and applicants are encouraged to propose other topics consistent with the goals of this program. Not all areas are required in a single application. o Identify specific chronically ill populations at increased risk (e.g., Alzheimer’s disease, rheumatoid arthritis, cardiopulmonary disease, cancer survivors, patients with alcohol problems) of chronic partial sleep deprivation and identify the etiology of excessive daytime sleepiness, apart from sleep disorders within these populations o Identify factors contributing to sleep deprivation (e.g., shift work, occupational demands, environmental conditions, alcohol and drug use, lifestyle choices, stress, medical treatment sequelae) and whether age, gender, and ethnicity may play a role o Determine the physiological, cognitive, behavioral, and psychosocial risks associated with varying lengths of sleep deprivation for both acute and chronic partial sleep deprivation in children, adolescents and adults o Elucidate the role of evening or bedtime alcohol use in sleep deprivation, and investigate the contribution of sleep deprivation to risk-taking behaviors such as drug and alcohol consumption o Identify effective recovery patterns following chronic partial sleep loss and whether rates of recovery vary by age and/or for physiological, behavioral and cognitive processes o Determine the restorative function of sleep in maintenance of health o Determine the relationship between menopause (natural or medically induced) and sleep disturbances o Develop interventions to improve the quality of sleep and to prevent sleep deprivation from occurring in healthy and chronically ill individuals across the lifespan including neonates, children, adolescents, adults, and older persons o Identify strategies to help children and adults adapt to the sleep disturbance associated with hospitals, critical care settings, and nursing homes o Develop and use improved approaches to assess acute and chronic sleep deprivation o Determine whether measurements of sleep quality can predict response to treatment of alcoholism and mental disorders across the life cycle o Determine how sleep patterns are affected by alcohol and psychoactive drug use and how the withdrawal from alcohol and drug use affects sleep patterns o Identify the relationship between partial sleep deprivation in children and adolescents and the relationship to possible effects on learning and behavior problems o Determine whether different stages of development alter the consequences of sleep deprivation in children and/or whether sleep is required for adequate growth and development INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html NOTE FOR APPLICATIONS FOCUSED ON AGING RESEARCH Some applications received in response to this program announcement are expected to focus on scientific issues related to aging and to aging-related aspects of disease. In this regard applicants may use Justification 1, the research topic to be studied is irrelevant to children, from the policy announcement. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. (This is not a Form page). o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and all future budget years. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Karin F. Helmers, PhD National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892 Tel: (301) 594-2177 Fax: (301) 480-8260 Email: karin_helmers@nih.gov Michael Twery, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Rockledge 2, Suite 10018 Bethesda, MD 20892-7952 Tel: (301) 435-0202 Fax: (301) 480-3557 Email: TweryM@nhlbi.nih.gov Andrew A. Monjan, Ph.D., M.P.H. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307, MSC- 9205 Bethesda, MD 20892-9205 Tel: (301) 496-9350 Fax: (301) 496-1494 Email: am39m@nih.gov Ellen Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Bldg, Suite 402 6000 Executive Blvd, MSC 7003 Bethesda, MD 20892-7003 Tel: (301) 443-6545 Fax: (301) 594-0673 email: ewitt@willco.niaaa.nih.gov Lynne Haverkos, MD, MPH Director, Behavioral Pediatrics and Health Promotion Research program National Institute on Child Health and Development 6100 Executive Blvd. Rm. 4B05B MSC 7510 Bethesda, MD 20892-7510 Tel: (301)435-6881 Fax : (301) 480-7773 email: haverkol@mail.nih.gov Harold W. Gordon, Ph.D. Clinical Neurobiology Unit Division of Treatment Research and Development National Institute on Drug Abuse Neuroscience Building Room 4234, MSC 9559 6001 Executive Boulevard Bethesda, MD 20892-9559 Tel: (301) 443-4877 Fax: (301) 443-6814 Email: hg23r@nih.gov Israel I. Lederhendler, Ph.D. Coordinator for Sleep Research National Institute of Mental Health National Institutes of Health 6001 Executive Boulevard, Room 7-170, MSC 9637 Bethesda, MD 20892-9637 Tel: 301/443-1576 Fax: 301/443-4822 e-mail: ilu@helix.nih.gov Noreen Aziz, MD, PhD, MPH Office of Cancer Survivorship Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd, MSC 7339 EPN Suite 539 Bethesda, MD 20892-7339 Tel: (301) 496-0598 Fax: (301) 496-8675 Email: na45f@nih.gov Direct inquiries regarding fiscal matters to: Cindy McDermott Office of Grants and Contract Management National Institute of Nursing Research Building 45, Room 3AN-12 6300 Center Drive MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-5979 Fax: (301) 480-8260 E-mail: cindy_mcdermott@nih.gov Raymond Zimmerman Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154, MSC 7926 Bethesda, Maryland 20892_7926 Telephone: 301 435_0171 Fax: 301 480_3310 Email: ZimmermR@nih.gov Joe Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Fax: (301) 402-3672 E-mail: ellisj@exmur.nia.nih.gov Judy Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Blvd, MSC 7003 Bethesda, MD 20892-7003 Phone: (301) 443-2324 Fax: (301) 443-3891 E-mail: jsimons@willco.niaaa.nih.gov Edgar D. Shawver Grants Management Branch National Institute of Child Health and Human Development Bldg. 6100, Rm. 8A17 9000 Rockville Pike MSC 7510 Bethesda, Md. 20892-7510 Tel: 301 435-6999 Fax: 301 402-0915 Email: ds117g@nih.gov Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse The Neuroscience Center 6001 Executive Boulevard, Room 3119 Bethesda, MD 20892 Tel: 301-443-6710 Fax: 301-594-6849 e-mail: gf6s@nih.gov Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, MSC 9605 Bethesda, MD 20892-9605 Tel: 301-443-2805 Fax: 301-443-6885 e-mail: Diana_Trunnell@nih.gov Bill Wells Executive Plaza South 243 Grants Administration Branch National Cancer Institute Bethesda, MD, 20892 Tel: 301-496-8796 Fax: 301-496-8601 e-mail: ww14j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361 (NINR), No. 93.837 (NHLBI), No. 93.866 (NIA), No. 93.273 (NIAAA), No. 93.865 (NICHD), No. 93.279 (NIDA), No. 93.242 (NIMH), and No. 93.399 (NCI). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement (10-98). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, and portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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