Improving CPAP use among African Americans with sleep apnea
A Pilot Study to Determine the Feasibility of a Couples' Oriented Intervention to Promote CPAP Adherence Among African American Patients With Obstructive Sleep Apnea
This study is testing a new couple-focused program to see if it can help African Americans with sleep apnea use their CPAP machines more regularly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05955287 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of a couple-oriented intervention designed to enhance CPAP adherence in African American patients suffering from moderate to severe obstructive sleep apnea. The study will involve 20 participants and their partners, who will be randomly assigned to either receive standard care or the couple-oriented intervention, which includes education, personalized fittings, and support groups. The intervention also incorporates cognitive behavioral therapy sessions to improve knowledge and self-efficacy regarding CPAP use. The goal is to determine the feasibility of this approach in improving adherence rates.
Who should consider this trial
Good fit: Ideal candidates for this study are African American adults aged 18 and older who have a bed partner and are diagnosed with moderate to severe obstructive sleep apnea.
Not a fit: Patients who are terminally ill, mentally incompetent, or have unstable housing may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve CPAP adherence rates among African American patients with sleep apnea, leading to better health outcomes.
How similar studies have performed: While there have been studies focusing on CPAP adherence, this couple-oriented approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must have same bed partner(s) for at least 6 months. * Must be at least 18 years of age Exclusion Criteria: * Must be Proficient in speaking English * Non-compliance to management of OSA * Apnea hypopnea Index ≥ 15 events/hours * Terminally ill * Mentally incompetent * unstable housing * need for BPAP or VPAP\\PAP).
Where this trial is running
Cleveland, Ohio
- MetroHealth Medical System — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: John D Thornton, MD, MPH — MetroHealth System, Ohio
- Study coordinator: John D Thornton, MD,MPH
- Email: dthornton@metrohealth.org
- Phone: 216-778-3732
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.