NCT07447284

The Improving Sleep in African American Couples Study (ISAAC)

The Improving Sleep in African American Couples (ISAAC) Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multiple site randomized controlled trial of 220 African American patients diagnosed with moderate to severe OSA and their bed partners. Half of the patients will receive optimal usual care, consisting of sleep therapist-initiated CPAP education and training. Patients will follow up with their sleep providers per usual. The remaining patients and their bed partners will receive a couple-oriented intervention consisting of optimal usual care. Couples will participate in couple-oriented support groups led by an African American patient with long standing OSA treated with CPAP and their partner. Patients and partners will receive tailored text messages encouraging adherence. In addition, couples will receive cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

2 sites across 1 country: United States