Clinical trial Recruiting at 1 site Interventional Ages 30 and up

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 typeInterventional
Ages30 Years and up
SexAll
Enrollment440 (estimated)
SponsorMetroHealth Medical Center
Academic / other
Locations2 sites (Cleveland, Ohio and 1 other locations)
StatusRecruiting
StartedJuly 24, 2026
Main results expectedJuly 2028
Study endsJuly 2028
Registry record updatedAugust 27, 2026
Trial IDNCT07447284 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.