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NCT07447284NARecruiting

The Improving Sleep in African American Couples Study (ISAAC)

MetroHealth Medical Center

Start Date

7/24/2026

Completion Date

7/1/2028

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.

Eligibility Criteria

Age Range: 30 years to No maximum

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

Interventions

BEHAVIORAL

CPAP Training and Education

BEHAVIORAL

Virtual Disease Support Group Sessions

BEHAVIORAL

Couple CPAP Training and Education

BEHAVIORAL

Couples Virtual OSA Support Group Sessions

BEHAVIORAL

CPAP Tele-monitoring and Feedback

BEHAVIORAL

Couples' Cognitive Behavioral Therapy

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Conditions

Obstructive Sleep Apnea (OSA)

Locations

The MetroHealth System

Cleveland, Ohio 44109

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States