The National Heart, Lung, and Blood Institute (NHLBI) is offering a Clinical Trials Planning Grant Cooperative Agreement (U34) to conduct pilot studies evaluating the treatment of obstructive sleep apnea (OSA) using positive airway pressure (PAP). This grant is for the purpose of assessing the feasibility of long-term (12-18 months) PAP treatment in patients at high risk for cardiovascular disease (CVD) who have established OSA and no prior PAP experience. Studies will also gather data on PAP’s impact on surrogate markers of cardiovascular risk, such as vascular dysfunction, inflammatory markers, and metabolic function. The initiative aims to identify optimal study design strategies for future event-driven Phase III clinical trials, focusing on recruitment, retention, PAP adherence, and potential changes in CVD risk profiles.
Opportunity ID: 50418
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-10-023 |
| Funding Opportunity Title: | Reducing Cardiovascular Disease Risk Through Treatment of Obstructive Sleep Apnea (U34) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 27, 2009 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jan 21, 2010 |
| Current Closing Date for Applications: | Jan 21, 2010 |
| Archive Date: | Feb 21, 2010 |
| Estimated Total Program Funding: | $1,500,000 |
| Award Ceiling: | $650,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Small businesses State governments Native American tribal governments (Federally recognized) City or township governments Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Independent school districts County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities For profit organizations other than small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | Purpose. The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) solicits three-year Clinical Trials Planning Grant Cooperative Agreement (U34) applications from institutions or organizations for pilot studies evaluating the treatment of obstructive sleep apnea (OSA) using positive airway pressure (PAP). The purposes of these studies are twofold. First, the studies should be designed to provide information regarding feasibility of long-term (12 to 18 months) PAP treatment of OSA in patients at risk of CVD. Second, the studies should provide data regarding the effects of PAP on surrogate markers of cardiovascular risk. Outcomes relevant for this FOA are broad and include a range of feasibility metrics (recruitment, retention, randomization, dose of PAP treatment, and design of control groups) and adherence outcomes (measures of patient acceptance of, satisfaction with, and adherence to PAP treatment); sympathetic nervous system hyperactivity; vascular dysfunction; inflammatory markers; platelet aggregation; and neuroendocrine and metabolic function. Populations that are at high risk for cardiovascular disease with established OSA and no prior history of PAP treatment will be the central focus of this initiative. Specific goals are to establish feasibility of long-term PAP treatment in high-risk individuals, to evaluate the potential for such treatment to produce changes in cardiovascular disease risk profiles, and to identify feasibility of study design strategies for future event-driven Phase III clinical trials. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-10-023.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| ADOBE-FORMS-A | Adobe-Forms-A | PKG00014835 | Dec 21, 2009 | Jan 21, 2010 | View |
Package 1
Mandatory forms
50418 RR_SF424-1.1.pdf
50418 RR_KeyPersonExpanded-1.1.pdf
50418 RR_OtherProjectInfo-1.1.pdf
50418 RR_PerformanceSite-1.1.pdf
50418 PHS398_CoverPageSupplement-1.1.pdf
50418 PHS398_ResearchPlan-1.1.pdf
50418 PHS398_Checklist-1.1.pdf
Optional forms
50418 PHS398_CoverLetter-1.1.pdf
50418 PHS398_ModularBudget-1.1.pdf
50418 RR_Budget-1.1.pdf
50418 RR_SubawardBudget-1.2.pdf
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