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NOT YET RECRUITING
NCT07447284
NA

The Improving Sleep in African American Couples Study (ISAAC)

Sponsor: MetroHealth Medical Center

View on ClinicalTrials.gov

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.

Official title: The Improving Sleep in African American Couples (ISAAC) Study

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2026-03-01

Completion Date

2028-07

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

CPAP Training and Education

Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.

BEHAVIORAL

Virtual Disease Support Group Sessions

Patients will attend 3 virtual webinars on prevention and management of diseases affecting the Black community including hypertension, obesity, cardiovascular disease, and cancer led by African American providers.

BEHAVIORAL

Couple CPAP Training and Education

Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.

BEHAVIORAL

Couples Virtual OSA Support Group Sessions

Patient and their bed partner will participate in 3 virtual group sessions moderated by an African American patient with longstanding OSA who regularly uses CPAP and their bed partner.

BEHAVIORAL

CPAP Tele-monitoring and Feedback

Patients' CPAP adherence will be regularly monitored and automated feedback provided to patient and bed partner when there is change in CPAP use.

BEHAVIORAL

Couples' Cognitive Behavioral Therapy

Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.

Locations (2)

The MetroHealth System

Cleveland, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States