The Improving Sleep in African American Couples Study (ISAAC)
ISAAC
2 other identifiers
interventional
440
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
March 3, 2026
February 1, 2026
2.3 years
February 22, 2026
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Mean Nightly CPAP Use
From enrollment to 30 days, 90 days, and 6 months.
Patient and Bed Partner Quality of Sleep
From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
From enrollment to 30 days, 90 days, 6 months, and 1 year.
- +6 more secondary outcomes
Study Arms (2)
Usual Care
PLACEBO COMPARATORPatients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual.
Couple-oriented Intervention Arm
ACTIVE COMPARATORPatients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following 1. CPAP instruction from sleep technologist 2. 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner 3. Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes 5\. 5 cognitive behavioral couple therapy sessions
Interventions
Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.
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.
Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.
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.
Patients' CPAP adherence will be regularly monitored and automated feedback provided to patient and bed partner when there is change in CPAP use.
Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.
Eligibility Criteria
You may qualify if:
- 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
- Bed partner for ≥ 6 months and willing to participate
- English proficient
You may not qualify if:
- Terminal illness
- Neurocognitive disorder that prevents informed consent
- Unstable housing
- Need for other forms of positive airway pressure (BPAP or VPAP)
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MetroHealth Medical Centerlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Pittsburghcollaborator
- MetroHealth System, Ohiocollaborator
Study Sites (2)
The MetroHealth System
Cleveland, Ohio, 44109, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Thornton, MD, MPH
MetroHealth System, Ohio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 22, 2026
First Posted
March 3, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
March 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be available from 1 to 4 years after the conclusion of the study.
- Access Criteria
- Those with access to NHLBI BioData Catalyst will have access to study data.
Study data will be de-identified according to HIPAA and the Common Rule. It will subsequently be available through NHLBI BioData Catalyst.