The Improving Sleep in African American Couples Study (ISAAC)

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.

Conditions

• Obstructive Sleep Apnea (OSA)

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Pittsburgh

  collaborator OTHER

• MetroHealth System, Ohio

  collaborator OTHER

• MetroHealth Medical Center

  lead OTHER

Principal Investigators

• John Thornton, MD, MPH · MetroHealth System, Ohio

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-24

Primary Completion

2028-07-31

Completion

2028-07-31

Countries

• United States

Study Locations