Recruiting

Behavioral Intervention

Sponsor:

MetroHealth Medical Center

Code:

NCT07447284

Conditions

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

CPAP Training and Education

Virtual Disease Support Group Sessions

Couple CPAP Training and Education

Couples Virtual OSA Support Group Sessions

CPAP Tele-monitoring and Feedback

Study Details

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.

Conditions

Obstructive Sleep Apnea (OSA)

Study ID

NCT07447284

Start date

Jul 24, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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 Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

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

CPAP Training and Education

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

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.

Couple CPAP Training and Education

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

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.

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.

Couples' Cognitive Behavioral Therapy

Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.

Primary outcome measure

  • Mean Nightly CPAP Use at 1 Year [ Time Frame: From enrollment until 1 year. ]

Central Contacts and Locations

Central contacts

Marquisha Marbury

216-778-8484mmarbury@metrohealth.org

Locations

The MetroHealth System

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Marquisha Marbury

2167788484mmarbury@metrohealth.org

Principal Investigator:

John Thornton, MD, MPH

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Sleep Apnea Syndromes/Therapy
  • Continuous Positive Airway Pressure
  • Couples Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2026-08-27.