The Improving Sleep in African American Couples Study (ISAAC) (ISAAC)

The Improving Sleep in African American Couples (ISAAC) Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marquisha Marbury; Phone Number: 216-778-8484; Email: mmarbury@metrohealth.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • The MetroHealth System
      • Contact: Marquisha Marbury; Phone Number: 2167788484; Email: mmarbury@metrohealth.org
      • Principal Investigator: John Thornton, MD, MPH
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
      • Contact: Stuti Vaidya, MPH; Phone Number: 4129006637; Email: vaidyas@upmc.edu
      • Principal Investigator: Sanjay Patel, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Care; Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual.	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.
Active Comparator: Couple-oriented Intervention Arm; Patients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following; CPAP instruction from sleep technologist; 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner; Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes 5. 5 cognitive behavioral couple therapy sessions	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment until 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to 30 days, 90 days, and 6 months.
Patient and Bed Partner Quality of Sleep	Epworth Sleepiness Scale	From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep	PROMIS Sleep Disturbance Index	From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep	PROMIS Sleep-Related Impairment	From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep	Functional Outcomes of Sleep short version	From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep	Actigraphy Data	6 months
Patient and Bed Partner Quality of Life	General quality of life will be assessed using the SF-12	From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Sleep Apnea Quality of Life	Sleep apnea-related quality of life will be assessed using the Calgary Sleep Apnea Quality of Life Index.	From enrollment to 30 days, 90 days, 6 months, and 1 year.
Sleep Apnea Beliefs	Sleep apnea knowledge will be assessed using the Apnea Beliefs Scale.	From enrollment to 30 days, 90 days, 6 months, and 1 year.
Sleep Apnea Knowledge	Sleep apnea knowledge will be assessed using the Apnea Knowledge Test.	From enrollment to 30 days, 90 days, 6 months, and 1 year.
Self-efficacy to Use CPAP	Self-efficacy to use CPAP will be assessed using the Self-Efficacy Measure in Sleep Apnea (SEMSA).	From enrollment to 30 days, 90 days, 6 months, and 1 year.

Collaborators and Investigators

• Sponsor: MetroHealth Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Pittsburgh; MetroHealth System, Ohio
• Investigators: Principal Investigator: John Thornton, MD, MPH, MetroHealth System, Ohio

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Couples Therapy; Sleep Apnea Syndromes/Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: STUDY00000597; R01HL169588 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data will be de-identified according to HIPAA and the Common Rule. It will subsequently be available through NHLBI BioData Catalyst.
• IPD Sharing Time Frame: Data will be available from 1 to 4 years after the conclusion of the study.
• IPD Sharing Access Criteria: Those with access to NHLBI BioData Catalyst will have access to study data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No