NCT07447284 · MetroHealth Medical Center
The Improving Sleep in African American Couples Study (ISAAC)
(ISAAC)
What this study is about
The goal of this randomly assigned 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.
View original scientific description
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.
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.
Primary outcome measures
Mean Nightly CPAP Use at 1 Year
Time frame: From enrollment until 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Terminal illness
- Neurocognitive disorder that prevents informed consent
- Unstable housing
- Need for other forms of positive airway pressure (BPAP or VPAP)
Where
- Cleveland, Ohio
- Pittsburgh, Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh, MetroHealth System, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations