The Improving Sleep in African American Couples (ISAAC) Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of this randomized study is to compare a combined behavioral intervention (remote tele-monitoring and feedback, virtual cognitive behavioral couple therapy, and couple-oriented peer support) on continuous positive airway pressure (CPAP) adherence, quality of sleep, functional status, and quality of life among patients with obstructive sleep apnea (OSA) and their bed partners.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:
• 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
• Bed partner for ≥ 6 months and willing to participate
• English proficient
Locations
United States
Ohio
The MetroHealth System
RECRUITING
Cleveland
Pennsylvania
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
Contact Information
Primary
Marquisha Marbury
mmarbury@metrohealth.org
216-778-8484
Time Frame
Start Date: 2026-07-24
Estimated Completion Date: 2028-07
Participants
Target number of participants: 440
Treatments
Placebo_comparator: Usual Care
Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual.
Active_comparator: Couple-oriented Intervention Arm
Patients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following~1. CPAP instruction from sleep technologist~2. 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner~3. Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes~5\. 5 cognitive behavioral couple therapy sessions
Related Therapeutic Areas
Sponsors
Leads: MetroHealth Medical Center
Collaborators: MetroHealth System, Ohio, University of Pittsburgh, National Heart, Lung, and Blood Institute (NHLBI)