Opportunity Information: Apply for RFA HL 10 023
Apply for RFA HL 10 023
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Reducing Cardiovascular Disease Risk Through Treatment of Obstructive Sleep Apnea (U34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233 National Center on Sleep Disorders Research 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research.
- This funding opportunity was created on Nov 27, 2009 and posted on Nov 27, 2009.
- Applicants must submit their applications by Jan 21, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $650,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Special district governments County governments Private institutions of higher education State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities For profit organizations other than small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses.
- 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.
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Opportunity Summary:
The grant opportunity "Reducing Cardiovascular Disease Risk Through Treatment of Obstructive Sleep Apnea (U34)" (Funding Opportunity Number RFA HL 10 023) is an NIH/NHLBI cooperative agreement designed to support early-stage clinical trial planning and pilot work focused on obstructive sleep apnea (OSA) treatment as a strategy to reduce cardiovascular disease (CVD) risk. The mechanism is a three-year Clinical Trials Planning Grant Cooperative Agreement (U34), which signals that awardees are expected to work collaboratively with NIH staff and that the emphasis is on generating the practical and scientific groundwork needed before launching a larger, definitive clinical trial.
At its core, the program is looking for pilot studies that evaluate positive airway pressure (PAP) therapy in people who already have OSA, are at high risk for cardiovascular disease, and have not previously been treated with PAP. The initiative is built around two main objectives. First, applicants must test whether it is realistically feasible to deliver and sustain long-term PAP treatment over roughly 12 to 18 months in this higher-risk population. Second, the pilot studies must collect data on how PAP affects surrogate markers tied to cardiovascular risk, meaning biologic and physiologic indicators that reflect changes in pathways related to heart and vascular disease even if the study is not large or long enough to measure hard clinical endpoints like heart attacks or strokes.
Because the goal is to prepare for future large-scale, event-driven Phase III trials, the funding announcement places heavy weight on feasibility and implementation outcomes. Projects are expected to generate clear evidence about whether patients can be found, enrolled, and kept in a study for a year or more, and whether randomization procedures work smoothly in real-world settings. The announcement explicitly calls out typical feasibility metrics such as recruitment rates, retention and follow-up completion, success of randomization, delivered "dose" of PAP treatment (often meaning actual nightly usage and exposure over time), and the practicality and credibility of control-group designs. Control-group design is highlighted because PAP trials can be challenging: investigators must consider how to maintain masking or minimize bias, how to create a comparison condition acceptable to participants, and how to avoid high dropout or cross-over that could undermine interpretation in later definitive trials.
A major related emphasis is adherence and acceptability, since PAP effectiveness depends strongly on consistent use. Applicants are expected to measure and report outcomes that reflect how well participants tolerate and accept PAP, their satisfaction with treatment, and objective adherence data. In PAP research, adherence is often captured via device-recorded usage metrics (for example, hours of use per night, proportion of nights used, or sustained use over months), and the announcement signals that understanding these patterns in a high-CVD-risk population is essential before scaling up to larger trials.
On the cardiovascular side, the FOA encourages collection of surrogate outcomes spanning several mechanistic domains linked to both OSA and cardiovascular risk. These include measures related to sympathetic nervous system hyperactivity, vascular dysfunction, inflammatory markers, platelet aggregation, and neuroendocrine and metabolic function. In practical terms, that could translate to examining how PAP impacts things like autonomic balance, endothelial function, systemic inflammation, pro-thrombotic activity, and metabolic regulation, since OSA has been associated with intermittent hypoxia and sleep fragmentation that can worsen these pathways. The FOA deliberately keeps the outcomes broad, giving investigators flexibility to select scientifically justified markers that fit their study design and the patient population being targeted.
The intended population is clearly defined: individuals with established obstructive sleep apnea who are at high risk for cardiovascular disease and who have not previously used PAP. This focus is meant to avoid confounding from prior PAP exposure and to prioritize participants most likely to benefit if PAP meaningfully improves cardiovascular risk profiles. The end goal is not simply to show short-term physiological change, but to determine whether a longer-term PAP intervention is doable, acceptable, and capable of moving risk-related biomarkers in a favorable direction, thereby justifying a subsequent large Phase III outcomes trial.
Administratively, this was a discretionary health funding opportunity offered by the National Institutes of Health, with an expected two awards and an estimated total funding level of $1.5 million. The award ceiling listed is $650,000, and there is no cost sharing or matching requirement. The posted date was November 27, 2009, with an original and current closing date of January 21, 2010, and an archive date of February 21, 2010. The program is associated with CFDA numbers 93.233 (National Center on Sleep Disorders Research), 93.837 (Cardiovascular Diseases Research), and 93.838 (Lung Diseases Research, reflecting the cross-cutting nature of sleep apnea across heart and lung health.
Eligibility was broad and included many types of organizations: public and private institutions of higher education, nonprofits (including 501(c)(3) and certain others), for-profit organizations other than small businesses, small businesses, and a range of government entities (state, county, city/township, special district), as well as tribal governments and tribal organizations. The eligibility section also explicitly included organizations such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, regional organizations, and U.S. territories or possessions, along with eligible federal agencies.
Overall, the opportunity was structured as a bridge between basic evidence that PAP can improve sleep apnea and the larger unanswered question of whether treating OSA can meaningfully reduce cardiovascular risk over the long term. By funding pilot studies that stress-test recruitment, adherence, retention, and control-group approaches while simultaneously tracking biologic markers tied to CVD pathways, the NHLBI aimed to build a solid foundation for the design of rigorous, event-driven Phase III clinical trials in the future.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Reducing Cardiovascular Disease Risk Through Treatment of Obstructive Sleep Apnea (U34)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA HL 10 023.
Which agency is offering this opportunity?
This is a National Institutes of Health (NIH) opportunity administered through the National Heart, Lung, and Blood Institute (NHLBI).
What type of award mechanism is this?
The mechanism is a Clinical Trials Planning Grant Cooperative Agreement (U34) with a three-year project period.
What does it mean that this is a "cooperative agreement" (U34)?
A cooperative agreement indicates that awardees are expected to work collaboratively with NIH staff. The emphasis is on building the practical and scientific groundwork needed before launching a larger, definitive clinical trial.
What is the main purpose of this U34 program?
The program supports early-stage clinical trial planning and pilot work focused on treating obstructive sleep apnea (OSA) as a strategy to reduce cardiovascular disease (CVD) risk, with the larger goal of preparing for future event-driven Phase III trials.
What kind of intervention is the program centered on?
The FOA centers on positive airway pressure (PAP) therapy for people who already have obstructive sleep apnea.
Who is the intended study population?
The intended population is individuals with established obstructive sleep apnea who are at high risk for cardiovascular disease and who have not previously been treated with PAP.
Why does the FOA focus on participants who have not previously used PAP?
The FOA highlights this population to avoid confounding from prior PAP exposure and to focus on people most likely to show meaningful changes in feasibility, adherence, and cardiovascular risk-related markers when starting PAP.
How long is the PAP intervention expected to be sustained in these pilot studies?
The FOA emphasizes testing the feasibility of delivering and sustaining long-term PAP treatment over roughly 12 to 18 months.
What are the two main objectives applicants are expected to address?
First, applicants must test whether it is feasible to deliver and sustain long-term PAP treatment (about 12 to 18 months) in a high-CVD-risk OSA population. Second, applicants must collect data on how PAP affects surrogate markers tied to cardiovascular risk.
Does this funding support a large Phase III outcomes trial?
No. The FOA is designed to generate pilot and planning data needed before a larger, definitive (often event-driven) Phase III trial is launched.
What kinds of outcomes does the FOA prioritize?
The FOA places heavy weight on feasibility and implementation outcomes (for example, recruitment, retention, adherence, and practicality of study procedures), while also encouraging collection of surrogate cardiovascular risk markers.
What feasibility metrics are specifically called out in the FOA?
The FOA explicitly highlights feasibility metrics such as recruitment rates, retention and follow-up completion, success of randomization, delivered "dose" of PAP treatment (often reflected by actual nightly use over time), and the practicality and credibility of control-group designs.
What does "delivered dose" of PAP mean in this context?
In PAP studies, "delivered dose" commonly refers to actual exposure to therapy, often measured as device-recorded nightly usage (for example, hours per night, proportion of nights used, and sustained use over months).
Why does the FOA emphasize adherence and acceptability?
PAP effectiveness depends strongly on consistent use. The FOA expects projects to measure how well participants tolerate and accept PAP, their satisfaction with treatment, and objective adherence patterns to determine whether long-term PAP is realistic in this higher-risk population.
How is PAP adherence expected to be measured?
The FOA points to objective adherence data, typically captured through PAP device-recorded usage metrics (such as hours of use per night, proportion of nights used, and whether use is sustained over time).
What does the FOA say about control groups in PAP trials?
Control-group design is highlighted as a key challenge. The FOA signals that investigators need to consider how to maintain masking or minimize bias, create a comparison condition acceptable to participants, and reduce dropout or cross-over that could undermine later definitive trials.
Are applicants required to track cardiovascular outcomes like heart attacks or strokes?
No. The FOA emphasizes surrogate markers tied to cardiovascular risk pathways, acknowledging that pilot studies may not be large or long enough to measure hard clinical endpoints such as heart attacks or strokes.
What are "surrogate markers" in this FOA?
Surrogate markers are biologic and physiologic indicators that reflect changes in pathways related to cardiovascular risk, even if the study is not designed to detect differences in major clinical events.
What cardiovascular and biologic domains are suggested for surrogate outcomes?
The FOA encourages surrogate outcomes across mechanistic domains linked to OSA and cardiovascular risk, including sympathetic nervous system hyperactivity, vascular dysfunction, inflammatory markers, platelet aggregation, and neuroendocrine and metabolic function.
Does the FOA restrict investigators to a fixed list of surrogate outcomes?
No. The FOA keeps outcomes broad and gives investigators flexibility to select scientifically justified markers that match their study design and target population.
Why is the NHLBI funding this kind of pilot work?
The FOA is positioned as a bridge between existing evidence that PAP can treat sleep apnea and the larger question of whether treating OSA can meaningfully reduce cardiovascular risk over the long term. The goal is to build a solid foundation for designing rigorous Phase III trials.
How many awards were expected under this FOA?
The FOA anticipated approximately two awards.
What was the estimated total funding available?
The estimated total funding level was $1.5 million.
What is the award ceiling listed in the announcement?
The award ceiling listed is $650,000.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
When was this opportunity posted, and when did it close?
The posted date was November 27, 2009. The original and current closing date was January 21, 2010. The archive date was February 21, 2010.
Which CFDA numbers are associated with this program?
The opportunity is associated with CFDA 93.233 (National Center on Sleep Disorders Research), 93.837 (Cardiovascular Diseases Research), and 93.838 (Lung Diseases Research).
What types of organizations were eligible to apply?
Eligibility was broad and included public and private institutions of higher education; nonprofits (including 501(c)(3) and certain others); for-profit organizations other than small businesses; small businesses; and many government entities (state, county, city/township, special district), as well as tribal governments and tribal organizations, U.S. territories or possessions, and eligible federal agencies.
Did the FOA explicitly encourage applications from specific institution types?
Yes. The eligibility section explicitly included HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, and regional organizations.
What kinds of study design challenges is this FOA trying to "stress-test"?
Based on the FOA description, the pilot work is meant to stress-test real-world recruitment and enrollment, long-term retention and follow-up, randomization procedures, sustained PAP delivery and adherence, and control-group approaches that remain credible while minimizing bias, dropout, and cross-over.
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