An interventional study of CPAP Training and Education and Virtual Disease Support Group Sessions in Obstructive Sleep Apnea (OSA), sponsored by MetroHealth Medical Center. Recruiting at 2 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Treatment
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 440 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →MetroHealth Medical Center is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - Patient:
Inclusion Criteria - Bed Partner
Exclusion Criteria - Patient:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Virtual Disease Support Group Sessions
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
Behavioral: Couple CPAP Training and Education · Behavioral: Couples Virtual OSA Support Group Sessions · Behavioral: CPAP Tele-monitoring and Feedback · Behavioral: Couples' Cognitive Behavioral Therapy
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.
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.
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.
Patient and Bed Partner Quality of Sleep
Epworth Sleepiness Scale
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
PROMIS Sleep Disturbance Index
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
PROMIS Sleep-Related Impairment
Time frame: 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
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
Actigraphy Data
Time frame: 6 months
Patient-Reported Measure of OSA Treatment
Patient-Reported Longitudinal Assessment Tool for OSA (PLATO-11)
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year
Patient and Bed Partner Quality of Life
General quality of life will be assessed using the SF-12
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Plan to share: Yes — Study data will be de-identified according to HIPAA and the Common Rule. It will subsequently be available through NHLBI BioData Catalyst.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2028, 24 months after the start.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 24 months is below that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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