SLEEP AND SLEEP DISORDERS IN CHILDREN Release Date: June 6, 2001 RFA: RFA-HL-01-006 National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov) National Institute of Mental Health (http://www.nimh.nih.gov) National Institute of Nursing Research (http://www.ninr.nih.gov/) National Institute of Child Health and Human Development (http://www.nichd.nih.gov) Letter of Intent Receipt Date: September 20, 2001 Application Receipt Date: October 16, 2001 THIS RFA 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 RFA/PA. PURPOSE The purpose of this initiative is to improve our understanding of fundamental biological mechanisms through which sleep deprivation and sleep disorders affect the cardiopulmonary, hematological, immunological, mental, and behavioral health of children. Specific objectives are to advance our understanding of age-specific and individual requirements for sleep in children; define pathophysiological mechanisms underlying the emergence and progression of childhood sleep disorders; and identify genetic factors and phenotypic variations in sleep characteristics that determine childhood patterns of sleep and circadian rhythmicity. Basic and clinical research is needed to provide a better understanding of the inter-relationship between sleep and other physiological systems. Although sleep and sleep disturbances are important to health throughout childhood, the major focus of this RFA is on school-age children 4 to 18 years old. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Sleep and Sleep Disorders in Children, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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 RFA will use the National Institutes of Health (NIH) 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 RFA may not exceed four years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Awards will be made and managed by the National Heart, Lung, and Blood Institute (NHLBI) and/or National Institute of Child Health and Human Development (NICHD) and/or the National Institute of Mental Health (NIMH) and/or the National Institute for Nursing Research (NINR). Policies that govern the research grant programs of the NIH will prevail. The anticipated award date is July1, 2002. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined 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 FUNDS AVAILABLE The NHLBI intends to commit $3.1 million, the NICHD intends to commit $375,000, the NIMH intends to commit $375,000, and the NINR intends to commit $375,000 in total costs during fiscal year 2002 to fund eight to ten new grants in response to this RFA. An applicant may request a project period of up to four years and a budget for direct costs of up to $250,000 per year (10 modules). Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NHLBI, NICHD, NIMH, and NINR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background Sleep is widely recognized as an essential biological function, but the mechanisms through which sleep influences overall health, and the significance of sleep disorders at different stages of childhood development are not well understood. Sleep difficulties in young children are among the most common behavioral disturbances that families bring to the attention of pediatricians. Sleep disorders and sleep deprivation impair performance in school and diminish physical and mental health. Many children complain about feeling tired during the day. An estimated 20 to 30 percent of school-age children experiences some type of sleep disturbance and 15 percent report falling asleep during school. There is concern that children may be particularly vulnerable to abnormalities resulting from sleep disturbances that may contribute to subsequent morbidity and mortality risks and potentially significant dysfunction as adults. Sleep disturbances are associated with altered immune responsiveness and with hormonal abnormalities that reduce resilience to stress and the ability to regulate blood sugar. Disturbed sleep can also impair physical growth and sexual maturation by impeding the normal nocturnal secretion of growth hormone, and gonadotropins. Animal studies indicate that sleep deprivation alters the pattern of gene expression in the brain and accelerates the loss of brain cells. However, little is known about the impact of sleep deprivation on childhood development and its potential consequences on health. Certain sleep disorders such as narcolepsy emerge by adolescence and persist into adulthood. On average 14 years elapse between the onset of narcoleptic symptoms and correct diagnosis. Failing to recognize the condition may lead to mislabeling a child as having learning disabilities or mood disorders increasing the risk of impaired personal and professional development. Sleep apnea affects 1-3% of children and accumulating evidence indicates that apnea produces high blood pressure in children as young as two years old. Extrapolating from findings in adults, children with sleep apnea may be predisposed to cerebrovascular, cardiovascular, and infectious/ inflammatory diseases. Sickle cell disease has been associated with sleep apnea in children and some reports have linked apnea-induced hypoxemia with sickle crises. Insomnia, hypersomnia, and abnormal function of the body=s internal clock (the circadian pacemaker located in the suprachiasmatic nucleus) profoundly affects behavioral patterns in children but the neurobiology and genetic factors underlying these disorders and their impact on child health are not well understood. Parasomnia type disorders such as sleep terrors, enuresis, and bruxism may reflect a developmental process for many children that potentially interferes with school performance and aspects of physical health. Children with chronic illnesses such as HIV infection and asthma have more difficulty sleeping and may experience higher rates of sleep disturbances than the normal population. Children with sleep disturbances may remain untreated because indications for treatment are not well-defined and there is a paucity of mechanistic research to support the development of evidence-based strategies for diagnosis and treatment. Research Scope This RFA is designed to stimulate basic and clinical research that will advance our understanding of (1) the biological, age-specific and ontogenic requirements for sleep in healthy children; (2) pathophysiological mechanisms underlying the onset and progression of childhood sleep disorders; and (3) the effects of sleep disorders and sleep deprivation on the cardiopulmonary, immunological, hematological and behavioral health of children. Genetic control of normal sleep and phenotypic variations in the amount, timing, architecture, and electrophysiological characteristics of sleep have been reported, but the inter-relationship of these factors on the developmental maturation of sleep patterns and circadian rhythmicity, and on the emergence of sleep disorders in children needs to be determined. Listed below are examples of studies that would be responsive to this program. These are only illustrative examples and applicants are encouraged to propose other topics consistent with the goals of this program. Not all areas need to be addressed in a single application. o Elucidate the role of sleep timing and pattern in mechanisms regulating the growth and development of healthy children. o Elucidate the neurobiological and genetic basis of individual variation in the sleep response to physical fatigue or sleep deprivation in healthy children. o Elucidate the inter-relationship between sleep and host defense mechanisms in healthy children and in children with primary or secondary sleep disturbance. o Elucidate pathophysiological mechanisms linking sleep disturbances in children to autonomic, hormonal, immunological, or other abnormalities contributing to the development of heart, lung, and blood diseases. o Elucidate the role of sleep in the acquisition of childhood motor and behavioral skills, the control of attention, adaptive coping skills, and the developmental integration of new experiences (e.g. procedural learning, emotional maturation, and cognitive development). o Elucidate pathophysiological mechanisms linking sleep disturbances (e.g. sleep architecture, habits, and deprivation) in children to mental, behavioral, emotional, and cognitive abnormalities as well as changes associated with puberty. o Elucidate neurobiological mechanisms underlying the onset of sleep disorders such as narcolepsy, insomnia, and restless legs syndrome in children. o Identify biological and genetic factors that affect the susceptibility of children to circadian rhythm sleep disorders, especially delayed sleep phase syndrome. SPECIAL REQUIREMENTS In order to be considered responsive to this announcement, applications must propose hypothesis-driven studies that focus on biological requirements for sleep or the mechanisms linking sleep disturbances to cardiopulmonary, immunological, hematological, mental, or behavioral abnormalities in school- age children. For the purpose of this RFA, studies must focus on school-age children 4 to 18 years of age. If studies of the inter-relationship between chronic disorders and sleep are proposed, the focus must be on mechanisms underlying sleep disturbance. Studies of the circadian system, if proposed, must also be tightly coupled to mechanisms of sleep control. Studies proposing the use of nonmammalian species or in vitro preparations should clearly establish the relationship of these models to the goals set forth in this RFA. Collaborations and consortia promoting interdisciplinary approaches between scientists studying pediatric sleep disorders, cardiology, pulmonology, vascular and sickle cell disease, infectious disease, genetics, neurophysiology, endocrinology, immunobiology, and psychology are strongly encouraged. In such cases, each participant's contribution should be identified and well-integrated into the overall experimental design. The elucidation of ethnic, cultural, and environmental factors influencing sleep in children, and pharmacological studies focused on investigating the efficacy of sleep promoting agents or stimulants to counteract daytime somnolence or dyssomnias will not be supported under this RFA. Studies of drug and alcohol abuse, dementia, pain syndromes, anxiety disorders, and the disruptive effects of drug therapy on sleep would also be unresponsive to this RFA. Applications focused on the development of methodology, large clinical studies, or the establishment of large epidemiological cohorts that collect data for future studies are not within the scope of this program. Upon initiation of the program, periodic meetings will be organized to encourage the exchange of information among investigators who participate in this program. Travel funds for a two day meeting each year, most likely to be held in Bethesda, Maryland, must be included in the module calculation. Applicants must include a statement indicating their willingness to participate in these meetings. Applicants are encouraged to contact the program officials listed under INQUIRIES for further information. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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. 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. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent Dr. Deborah Beebe (see address listed under Inquiries below) by September 20, 2001. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714, email: GrantsInfo@nih.gov. 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a maximum of ten modules or $250,000 in direct costs per year. The 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 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 all 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 all 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. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Please note that color figures or photos present in the body of the grant application should also be present in the appendix, or high-quality reproductions of the pages containing color or half-tone figures should be included in the appendix. The reviewers will receive a black-and-white copy of the grant application together with the appendix. Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application as well as all five collated sets of Appendix material must be sent to Dr. Deborah Beebe at the address listed under Inquiries. Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR also will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Principal investigators should not sent supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you have not yet received such a letter, contact, Dr. Deborah Beebe at the address listed under Inquiries. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI, NICHD, NIMH, or NINR. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the NHLBI, NICHD, NIMH, and/or NINR Advisory Council(s). 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. (1) 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? (2) 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? (3) 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? (4) 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)? (5) 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. Schedule Letter of Intent Receipt Date: September 20, 2001 Application Receipt Date: October 16, 2001 Peer Review Date: February/March 2002 Council Review: May 2002 Earliest Anticipated Start Date: July 1, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael Twery, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Rockledge 2, Suite 10018, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: mt2d@nih.gov Lynne M. Haverkos, M.D., MPH Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05B, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6881 FAX: (301) 480-7773 E-mail: lh179r@nih.gov Israel I. Lederhendler, Ph.D. Coordinator for Sleep Research National Institute of Mental 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 Karin F. Helmers, Ph.D. National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Tel: (301) 594-2177 Fax: (301) 480-8260 Email: karin_helmers@nih.gov Direct inquiries regarding review issues, send letter of intent, and two copies of the application to: Deborah Beebe, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Dr.,Room 7178 (MSC 7924) Bethesda, MD 20892-7924 Telephone: (301) 435-0270 Fax: (301) 480-3541 Email: db57j@nih.gov Direct inquiries regarding fiscal matters to: Robert Vinson 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 E-mail: rv7g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.233, 93.242, 93.361, 93.837, 93.838, and 93.839. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 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. The PHS strongly encourages all grant 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, any 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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