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A PCORI Funding Announcement (PFA) will open on September 6, 2023 to fund high-quality, comparative clinical effectiveness research (CER) projects that focus on sleep health.
PCORI is particularly interested in applications which focus on sleep in high-need and/or underserved populations, including but not limited to:
- Shift workers
- Hospitalized patients
- Pregnant and postpartum persons
- Rural populations
- Low-income populations
- Persons with intellectual and developmental disabilities
- Sexual/gender minorities
- Racial/ethnic minorities
- Individuals with comorbid chronic conditions
Applications may propose comparative clinical effectiveness studies of screening, diagnostic and treatment approaches for sleep disorders (e.g., insomnia and/or obstructive sleep apnea [OSA]); interventions promoting sleep health; or system-level strategies delivered in hospital, clinic or community settings to improve patient-centered sleep outcomes.
PCORI is particularly interested in submissions that address the following Special Areas of Emphasis:
- Promoting sleep health equity
- Chronic conditions co-occurring with sleep disturbances
- Focus on sleep health beyond diagnosed sleep disorders
Trial Design
Individual, or cluster randomized, controlled trials. Well-specified natural experiments and well-designed observational studies will also be considered.
Population
Trials should include large and diverse populations with an overall sample size that will allow precision in the estimation of hypothesized effect sizes and, as appropriate, analysis of heterogeneity of treatment effect.
Outcomes
Well-justified sleep-related outcomes that are clinically meaningful and considered important by patients, which can be impacted by the proposed intervention within the study duration.
Funding
- Total allocated for this PFA: Up to $50 million
- Total direct funding: Up to $12 million, although PCORI may consider studies over this allocation if permission is granted by PCORI prior to submission of the letter of intent.
- For this funding announcement, applicants may request coverage of patient care costs (including medical products, procedures and care services) for potential funding by PCORI. These costs are included as part of the overall direct costs.
Maximum project duration
Five years.
Important dates
September 6 – Applications open
September 20 – Town Hall
October 3 – Letters of Intent due
January 9, 2024 – Applications due
April 2024 2023 – Merit review
July 2024 – Awards announced
November 2024 – Earliest start date
For more information or to request a brief consultation, please contact Leslie MacGregor, PCORI Funding Specialist: Leslie_MacGregor@hms.harvard.edu