The Improving Sleep in African American Couples Study (ISAAC)

MetroHealth Medical Center440 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

440

Conditions

Obstructive Sleep Apnea (OSA)

Interventions

CPAP Training and EducationBEHAVIORAL

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

Virtual Disease Support Group SessionsBEHAVIORAL

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.

Couple CPAP Training and EducationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (2)

The MetroHealth System

Cleveland, Ohio, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Mean Nightly CPAP Use at 1 Year

Mean CPAP use at year will be the total hours of CPAP use divided by the number of days observed for the patient over the course of a year.

Time frame: From enrollment until 1 year.

Secondary Outcomes

Mean Nightly CPAP Use

Mean CPAP use will be the total hours of CPAP use divided by the number of days observed for the patient over the course of the designated time interval.

Time frame: From enrollment to 30 days, 90 days, and 6 months.