Sleep Health Topical PCORI Funding Announcement -- Cycle 3 2023

This PCORI Topical PCORI Funding Announcement (PFA)  seeks to fund high-quality, comparative clinical effectiveness research (CER) projects that focus on sleep health. 

Research Initiative Highlights

Quality sleep is an important component of health and quality of life, but over 50 million people of all ages in the United States experience sleep-related problems. This Topical PFA will solicit applications focused on sleep health. PCORI is particularly interested in applications focusing 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, and 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.

Applications designed to develop new technology (such as mobile apps) will be considered nonresponsive. Cultural adaptation of efficacious technology-based interventions to promote sleep health equity in underserved communities may be responsive. Additionally, at least one primary outcome must be focused on improving sleep health.

PCORI is particularly interested in submissions that address the following Special Areas of Emphasis (SAEs):

1. Promoting Sleep Health Equity: Historically underserved and disenfranchised populations experience poorer sleep health than the general population and often lack access to adequate screening for and treatment of sleep disorders. PCORI is interested in studies comparing strategies to enhance access to efficacious screening and/or treatment for sleep disorders and to promote sleep health. Studies could include cultural tailoring as appropriate for specific populations.
2. Chronic Conditions Co-occurring with Sleep Disturbances: Sleep can be impacted by interventions designed to address chronic conditions co-occurring with sleep disturbances. PCORI is interested in studies of the effectiveness of interventions addressing health conditions such as obesity, mental health disorders (e.g., anxiety) and substance use disorders on the outcomes of sleep disorders (e.g., OSA and insomnia).
3. Focus on Sleep Health Beyond Diagnosed Sleep Disorders: Poor sleep can negatively impact physical and mental health in individuals without a diagnosed sleep disorder. PCORI is interested in studies comparing interventions designed for individuals with short or irregular sleep duration, irregular sleep-wake schedules, or otherwise disrupted sleep. Studies could focus on improving sleep health using technology-based interventions, clinical or care delivery interventions (e.g., improving provider assessment of sleep health), and/or addressing social needs with documented impact on sleep health, among other approaches.

The purpose of identifying these SAEs is to encourage submissions to these areas, not to limit submissions to these topics. Applicants addressing an SAE should identify the area that is best associated with their research approach.

Applicants are strongly encouraged to propose individual, or cluster randomized, controlled trials; however, well-specified natural experiments and well-designed observational studies will also be considered. Proposed studies should examine 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. Applicants are encouraged to pay special attention to issues of intervention implementation with an aim of facilitating widespread uptake of findings after completion of the study. However, strict implementation or dissemination studies will not be considered responsive nor will studies focused on the development of research methods. Applicants should propose well-justified sleep-related outcomes that are clinically meaningful and considered important by patients and that can be impacted by the proposed intervention within the study duration.

Applicants should consider, as appropriate, the full range of sleep-related clinical and patient-centered outcomes data relevant to patients and other stakeholders. PCORI’s Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research inform the expectations for applicants and the corresponding evaluation of applications submitted in response to this PFA.

This funding announcement will accept applications with direct costs up to $12 million dollars and up to five years in duration. 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. PCORI may consider applications that exceed the stated direct cost cap. Applicants must discuss such a request with PCORI to seek permission to exceed the direct cost cap prior to submission of a Letter of Intent.  Please contact PCORI ([email protected]) to schedule a consultation. For additional information, please see the full announcement.