OBSTRUCTIVE SLEEP APNEA IN CHILDREN NIH Guide, Volume 26, Number 39, December 5, 1997 RFA: HL-98-004 P.T. National Heart, Lung, and Blood Institute National Institute of Dental Research National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 30, 1998 Application Receipt Date: June 23, 1998 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS AND INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS AND MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The primary goal of this initiative is to define abnormalities in airway structure and function responsible for obstructive sleep apnea (OSA) in children (3-12 years of age) and to identify physiological and clinical measures associated with increased morbidity. Specific objectives include the identification of neural and soft tissue factors increasing airway collapsibility; soft tissue and craniofacial features that elevate airway resistance; defects in ventilatory control reflexes that compromise airway patency; the genetic and epidemiological risk factors for OSA; and the neuropsychological, cognitive, and behavioral consequences of OSA in children. It is anticipated that these studies will provide new strategies for the diagnosis and treatment of OSA in children. 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 request for applications (RFA), Obstructive Sleep Apnea in Children, is related to the priority areas of heart disease and stroke, chronic disabling conditions, mental health and disorders, oral health, maternal and infant health, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Foreign institutions may not apply. However, subcontracts to foreign institutions may be allowed if justified. Ethnic minority individuals, women, and persons with disabilities are especially encouraged to apply as principal investigators. Institutions submitting multiple applications in response to this RFA must ensure that each application is independent and does not have scientific overlap with other applications from the same institution. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) mechanism of support. Awards will be made and managed by the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Dental Research (NIDR), and/or the National Institute of Child Health and Human Development (NICHD). Policies that govern the research grants programs of the NIH will apply. However, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts currently being examined by the NIH. 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 in the application 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, applicant institutions, reviewers, and Institute staff. For this RFA, funds must be requested in $25,000 direct cost modules up to a maximum of 10 modules ($250,000 direct costs) per year. A feature of the modular grant concept is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information will be required in the application. Any budget adjustments made by the Initial Review Group will be in modules of $25,000. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page are not required as part of the initial application. If there is a possibility for an award, the necessary budget, Other Support and Checklist information will be requested by staff at NHLBI and/or NIDR and/or NICHD following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of these modifications to standard PHS 398 application kit instructions. This RFA is a one time solicitation. Future requests for continuation beyond this initial award period will compete with all investigator initiated applications and be reviewed according to customary peer review procedures. FUNDS AVAILABLE It is anticipated that during fiscal year 1999, support will be available for total costs of approximately $1,800,000 from the NHLBI, $600,000 from NIDR, and $200,000 from NICHD for the first year of this initiative. Award of grants pursuant to this RFA is contingent upon the receipt of such funds for this purpose. It is anticipated that approximately five to seven grants will be awarded under this program. Applicants may request up to four years of support. However, the specific number of awards will depend on the merit and scope of the applications received, overall program balance, and on the availability of funds. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Facilities and administrative (indirect) costs will be awarded based on the negotiated rates. RESEARCH OBJECTIVES Background Obstructive sleep apnea (OSA) is widely recognized as a potentially serious medical condition in adults. However, we do not know the prevalence of OSA in children or whether the OSA syndrome in children and adults represents the same disease process. Limited epidemiological data suggests that the prevalence of OSA may follow a bimodal distribution, with peaks in childhood and in later life, and that, unlike the syndrome in adults, obesity or daytime sleepiness may not be a reliable indicator of childhood OSA. Studies also suggest that ethnicity may be a significant risk factor, because African-American children appear to be two to three-fold more likely to have OSA than Caucasian children. However, without clearly established guidelines or thresholds to define clinically significant OSA in children, the use of adult criteria probably underestimates the true prevalence of OSA in this population. The lack of systematically collected data on the pathogenesis of OSA in children has contributed to inconsistencies in identifying and treating children at risk. For instance, children with OSA symptoms are routinely subjected to procedures modifying craniofacial and soft tissue features (e.g., tonsillectomy and adenoidectomy) without the benefit of definitive diagnostic tools or substantive evidence that surgery reduces health risks associated with sleep-disordered breathing or improves long-term outcome. OSA is most likely a manifestation of multiple risk factors including anatomical, neuromuscular, and hormonal factors. In children, the relative contribution of these factors to OSA may differ from that in adults and influence the effectiveness of specific therapies. Extrapolating from findings in adults, unrecognized OSA may predispose children to cardiovascular and cerebrovascular disease, learning/performance deficits, and decrements in several quality of life measures. For adults, OSA could be a modifiable risk factor for hypertension. However, very little is actually known about the specific risks associated with OSA in children including its effects on cardiovascular and respiratory control mechanisms; problem sleepiness; and cognitive, behavioral, and neuropsychological development. Adult data suggests that the successful treatment of OSA reduces some risks but the efficacy or appropriateness of these treatments in children is unclear. Research Scope Substantial data in adults indicate that precise interactions between airway anatomy and the control of pharyngeal dilator muscles are necessary to maintain airway patency. Sleep negatively impacts these interactions in some adults leading to airway collapse. However, these physiological interrelationships need to be investigated in children. How development affects airway anatomy, pharyngeal neuromuscular control, and regulation during sleep has been minimally studied in children. Whether pharyngeal muscles respond to similar stimuli in children as adults and are affected by sleep in a similar manner is unknown. Gender and obesity influences on airway anatomy and motor control also need to be explored in children. The mechanisms terminating apneas during sleep are reasonably well-defined in adults but have not been studied at all in children. The neural and chemosensory mechanisms controlling ventilation during sleep have been minimally studied in children particularly as they relate to development of sleep apnea. Arousal responses to obstructive events in children could have a different threshold and functional relationship to sleep compared to adults. Fundamental research is needed to establish indices in children for measures such as respiratory disturbance frequency, arousal, and oxygen desaturation and to define the natural history and pathophysiological mechanisms responsible for airway abnormalities and OSA during childhood. Precise definitions of OSA phenotypes are essential to conduct studies into the genetic basis of childhood abnormalities in ventilation. Among the traits that are likely to be responsible for OSA in children, are differences in craniofacial structure, soft tissue structures, obesity, and neural control of the airway. A number of genetic disorders, such as Down's syndrome and Treacher Collins syndrome, may induce changes in craniofacial or soft tissue growth and increase the risk of OSA in children. Studies are needed to determine the genes and nature of genetic abnormalities affecting craniofacial structure/function, airway size, and sleep in order to develop appropriate therapeutic strategies for OSA. Criteria for identifying children with clinically significant OSA need to be established to better associate health risks, and to determine whether procedures used in the diagnosis and treatment of OSA in adults are applicable to OSA in children. There is a need for studies to investigate whether OSA impairs the function of sleep in children and if there are cardiovascular, ventilatory, neuroendocrine, neuropsychological, cognitive, or behavioral consequences to apnea-induced hypoventilation and sleep fragmentation. For instance, it is not known whether OSA may cause emotional or behavioral difficulties; or impairs the learning ability, linguistic function, or working memory of children. Whether children may experience adverse health effects even when there is no evidence of sleep disruption needs to be studied. New techniques, such as functional magnetic resonance imaging, can facilitate studies of the intermittent changes in brain metabolism and neural behavior of OSA in children. There is evidence that abnormal neural endocrine growth hormone function in children with OSA may lead to growth retardation. Whether upper airway obstruction influences physical development or the growth of craniofacial features affecting airway function needs to be studied. Whether OSA influences the severity of other childhood respiratory disorders, such as asthma, is also an area in need of investigation. These topics serve as examples and are not a comprehensive or exclusive list of the areas that could be considered under this initiative. Not all areas are required in an application. Applicants are encouraged to propose other topics consistent with the goals of this program. SPECIAL REQUIREMENTS Proposed studies must focus on defining the abnormalities in airway structure and function responsible for OSA in children (3-12 years of age) or on identifying physiological and clinical measures associated with increased morbidity. Studies should provide strategies for either the diagnosis or treatment of OSA in children by determining risk factors or evaluating therapeutic approaches (e.g., tonsillectomy and adenoidectomy). However, large clinical studies or trials and the establishment of large descriptive epidemiological cohorts that collect data for future studies are not within the scope of this RFA. Applications that do not propose hypothesis-driven studies or are limited to measuring the efficacy of potential treatments will be considered unresponsive to this RFA. Studies that focus on animal or in vitro models to test hypotheses must provide a strong rationale for relevance to airway abnormalities and apnea in children. Applications directed at the development of model systems alone will not be accepted. Collaborations and consortia promoting interdisciplinary approaches between pulmonologists, neurologists, epidemiologists, neuroendocrinologists, psychologists, otolaryngologists, and other clinical or basic disciplines are strongly encouraged. In such cases, each participant's contribution should be identified and well-integrated into the overall experimental design. Upon initiation of the program, the NHLBI, NIDR, and NICHD may co-sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. Travel funds for a one day meeting each year, most likely to be held in Bethesda, Maryland, should be included in the module calculation. Applicants should also include a statement indicating their willingness to participate in these meetings. 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 of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies of the policy from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 30, 1998, 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, 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 subsequent applications, the information that it contains allows NIH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be faxed or sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). 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) 710-0267, E-mail: ASKNIH@od.nih.gov. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. 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, to identify the application as a response to this RFA, check "YES" in item 2 of page 1 of the application and enter the title "Obstructive Sleep Apnea in Children, HL-98-004". The following modifications are made to the standard PHS 398 application instructions: BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and modifications made to the standard PHS 398 application instructions as described below: o FACE PAGE As a reminder, Item 7 should be completed to indicate Modular Direct Costs requested and Item 8 should reflect Total Costs (Modular Direct plus facilities and administrative costs). o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete Form Page 4 of the PHS 398 (rev 5/95). It is not required nor will it be accepted at the time of application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev. 5/95). Only the requested total direct costs line for each year must be completed based on the number of $25,000 modules being requested. Applicants may not request a change in the amount of each module. A maximum of 10 modules ($250,000 direct costs) per year may be requested and each applicant may request up to four years of support for this RFA. Equipment is included in the budget limitation. If an application includes research activities that involve institutions other than the application institution, the activity is considered a consortium effort. The total cost (direct costs and facilities and administrative) of consortium arrangements are included in the budget limitation. If there is a possibility of an award, applicants will be asked to confirm that the salary budgeted for any one project member does not exceed an annual rate cap of $125,000 per year in any budget period. Direct cost budgets will remain constant throughout the life of the project (i.e. the number of modules will not be subject to escalation). However, in the event that the number of modules required to accomplish the proposed research changes in any future year, appropriate justification must be provided. Total Direct Costs for the Entire Proposed Project Period should be shown in the box provided on Form Page 5. o BUDGET JUSTIFICATION -Budget justifications should be provided under "Justifications" on Form Page 5 of the PHS 398. -List the names, role on the project and proposed percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on their role on the project. -Identify all consultants by name and organizational affiliation and describe the services to be performed. -Provide a general narrative justification for individual categories (equipment, supplies, etc.) required to complete the work proposed. More detailed justifications should be provided for high cost items. Any large one-time purchases, such as large equipment requests, must be accommodated within the budget limitations. -Separate justification should be provided for the use of grant funds to support a scientific element of the project outside the United States or its territories including but not limited to travel, surveying, and data or sample collection. o CONSORTIUM/CONTRACTUAL COSTS If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of intent from each collaborating institution should be submitted with the application. Only the percentage of the consortium/contractual TOTAL COSTS (direct plus facilities and administrative costs) relative to the total DIRECT COSTS of the overall project needs to be stated at this time. The following example should be used to indicate the percentage cost of the consortium, "The consortium agreement represents 27% of overall $175,000 direct costs requested in the first year". A budget justification for the consortium should be provided as described in the "Budget Justification" section above (no Form Page 5 required for the consortium). Please indicate whether the consortium will be in place for the entire project period and identify any future year changes in the percentage relative to the parent grant. If there is a possibility for an award, the applicant will be requested to identify the actual direct and facilities and administrative costs for all years of the consortium. Please note that total subcontract costs are not to be calculated in $25,000 modules. However, when subcontract funds are added to the parent grant budget, the total cost of the consortium or contract must be included in the number of $25,000 modules requested. o BIOGRAPHICAL SKETCH -Biographical sketches are required for key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. -Complete the educational block at the top of the form page; -List current position(s) and those previous positions directly relevant to the application; -List selected peer-reviewed publications directly relevant to the proposed project, with full citation; -The applicant has the option to provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. o OTHER SUPPORT Do not complete the "Other Support" pages (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete Other Support information will be requested by the staff of NHLBI or collaborating Institutes if there is a possibility for an award o CHECKLIST No "Checklist" page is required as part of the initial application. A completed Checklist including a breakdown of facilities and administrative cost calculations (rate, base, and base exclusions) will be requested by the staff of NHLBI or collaborating Institutes if there is a possibility for an award. 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. APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW. Submit a signed, typewritten original of the application 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 must be sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. Applications must be received by June 23, 1998. If an application is received after this 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 will also 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. A sample budget is available upon request from Mr. Raymond Zimmerman at the phone number listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness to this RFA by the collaborating Institutes. 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 receive primary assignment to NHLBI and receive secondary assignment to NIDR and NICHD. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, NHLBI. Final Institute primary assignments will be determined by the collaborating Institutes. As part of the initial merit review, all applications will receive a written critique and undergo a review in which only those applications deemed to have the highest scientific merit of the applications under review (usually two to three times the number of applications that the NHLBI and participating Institutes anticipate being able to fund under the program) will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council and the Advisory Councils of NIDR and/or NICHD. The following criteria will be considered when assessing the scientific and technical merit of a research grant application: (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 key personnel? (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? The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. AWARD CRITERIA The anticipated date of award is March 1, 1999. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score, the availability of funds, relevance to the scientific programs of the participating Institutes, and overall programmatic balance. Subject to the availability of necessary funds and consonant with the priorities of this RFA, the NHLBI and/or NIDR and/or NICHD will provide funds for a project period up to four years. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael J. Twery, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7024, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: TweryM@nih.gov James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 7024, MSC-7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: KileyJ@nih.gov Linda A. Thomas, Ph.D. Inherited Diseases and Disorders Program National Institute of Dental Research 45 Center Drive, Room 4AN24J Bethesda, MD 20892-6402 Telephone: (301) 594-2425 FAX: (301) 480-8138 Email: ThomasL@DE45.nidr.nih.gov G. Reid Lyon, Ph.D. Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-9849 FAX: (301) 480-7773 Email: LyonR@hd01.nichd.nih.gov Direct inquiries regarding review matters and address the letter of intent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: ScheireJ@nih.gov Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: ZimmermR@gwgate.nhlbi.nih.gov Martin R. Rubinstein Grants Management National Institute of Dental Research 45 Center Drive, Room 4AN44A Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: Martin.Rubinstein@nih.gov Edgar D. Shaver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: ShawverD@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. 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, 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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