Couple-focused mobile health intervention to improve CPAP use for sleep apnea
OurSleepKit: A Couple-focused m-Health Intervention to Support Adherence to CPAP Treatment
This study is testing if a mobile health program for couples can help people with sleep apnea use their CPAP machines more regularly and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) NIH |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06621511 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if a mobile health intervention designed for couples can enhance adherence to continuous positive airway pressure (CPAP) therapy among patients newly diagnosed with obstructive sleep apnea (OSA). Participants, including both the patient and their partner, will receive supportive resources on their mobile devices before starting CPAP and continue for six months. The couples will engage with the materials at their own pace and provide feedback on their experiences at multiple intervals throughout the study. The goal is to assess the impact of partner involvement on CPAP usage and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of obstructive sleep apnea who are starting CPAP therapy and have a partner who is not using CPAP.
Not a fit: Patients with other sleep disorders, those planning bariatric surgery, or couples where one partner is already using CPAP will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve CPAP adherence, leading to better management of obstructive sleep apnea and enhanced quality of life for patients.
How similar studies have performed: Other studies have shown promising results with mobile health interventions aimed at improving treatment adherence, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients should be males or females (age≥18 years) with diagnosed OSA and candidates for CPAP therapy (with any type of pressure delivery mode), and are cohabiting with their partner for at least one year * The partners of eligible patients will be recruited if they are not diagnosed with OSA and not using CPAP * both partners should have their own mobile devices with access to the internet Exclusion Criteria: * have a diagnosis of a sleep disorder other than OSA based on a polysomnogram (e.g., central sleep apnea, narcolepsy, or periodic limb movement disorder) * have planned bariatric surgery (as they typically quit CPAP after surgery) * have a partner using CPAP * are pregnant because the changes in respiration and sleep quality occurring with pregnancy may confound the results. * couples with one or both partners doing regular overnight shift work or those unable to speak or write in English will be excluded.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Northeastern University — Boston, Massachusetts, United States (Not_yet_recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Lichuan Ye, PhD
- Email: l.ye@northeastern.edu
- Phone: 617-373-2582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.