Improving Sleep in African American Couples: A CPAP Adherence Study
Official title: The Improving Sleep in African American Couples (ISAAC) Study
Run by MetroHealth Medical Center · NCT07447284 · Data updated 2026-11-12
This study tests whether a couple-focused program including remote monitoring, virtual therapy, and peer support can help African American adults with moderate to severe sleep apnea use CPAP more consistently and sleep better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years and up |
| Sex | All |
| Enrollment | 440 (estimated) |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Status | Recruiting |
| Started | July 24, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT07447284 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 30 or older with moderate to severe OSA (AHI ≥ 15) and a bed partner willing to participate, who are English-speaking.
✕Probably not a fit
Patients without a willing bed partner or those not able to engage in telemedicine or behavioral therapy components may have limited benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial enrolls 220 African American patients with moderate to severe obstructive sleep apnea and their bed partners. Participants are randomized to either optimal usual care with CPAP education and standard follow-up, or to an enhanced couple-oriented program that adds tele-monitoring, tailored messages, and cognitive behavioral couple therapy led by a health psychologist. The intervention aims to improve CPAP adherence, sleep quality, functional status, and quality of life for both partners. The study leverages multiple sites and community-informed components to assess whether engaging couples improves treatment engagement and outcomes. Primary results will compare CPAP adherence between groups over the study period.
Why it matters
Potential benefit: If successful, the approach could improve CPAP use and overall well-being for patients with OSA and their partners.
How similar studies have gone: Previous studies suggest that behavioral and partner-supported approaches can improve CPAP adherence, but this specific couple-focused, tele-monitored program in African American patients is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria - Patient: * Moderate or severe OSA (Apnea hypopnea index ≥ 15 events/hour) * Age ≥ 30 years * Bed partner for ≥ last 6 months who is willing to participate * English proficient Inclusion Criteria - Bed Partner * Bed partner for ≥ 6 months and willing to participate * English proficient Exclusion Criteria - Patient: * Terminal illness * Neurocognitive disorder that prevents informed consent * Unstable housing * Need for other forms of positive airway pressure (BPAP or VPAP) * Pregnancy
Where it's running
-
The MetroHealth System
Cleveland, Ohio, United States Recruiting -
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States Not yet recruiting
Study contacts
- Principal investigator: John Thornton, MD, MPH — MetroHealth System, Ohio
- Study coordinator: Marquisha Marbury
- Email: mmarbury@metrohealth.org
- Phone: 216-778-8484
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.