App-based program to improve long-term CPAP use and quality of life
An App-Based, Precision Medicine Approach to Optimize Long-Term CPAP Adherence and Quality of Life
This project tests whether the SmartWell24 smartphone app can help adults with obstructive sleep apnea use their CPAP for at least six hours a night on six nights per week.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Trial ID | NCT06381115 on ClinicalTrials.gov |
What this trial studies
This interventional program will enroll newly diagnosed adults with obstructive sleep apnea who are prescribed CPAP and can use a smartphone and wearable sensor. Two parallel pilot cohorts of about 20 participants each will be recruited with balanced sex and OSA severity, and participants will use the SleepWell24 (SmartWell24) app alongside a wearable wrist sensor (Fitbit) to support CPAP adherence. The primary focus is increasing nightly CPAP use to at least six hours on most nights, with secondary measures including quality of life and device engagement. Study visits and enrollment are conducted at Mayo Clinic sites in Scottsdale, Arizona and Rochester, Minnesota.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults newly diagnosed with OSA who are prescribed CPAP, own a compatible smartphone (iOS9+/Android 4.2+), can use a wearable sensor, and receive care at the participating Mayo Clinic sites.
Not a fit: Patients without compatible smartphones or wearable use ability, those unwilling to use the Fitbit app, or those with medical or cognitive conditions that prevent engagement are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the app could help patients achieve more consistent CPAP use, leading to better sleep, daytime functioning, and overall quality of life.
How similar studies have performed: Previous digital coaching, telemonitoring, and app-based interventions for CPAP adherence have shown modest improvements, so this approach builds on existing but not definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * In both trials of Aim 2, twenty adults (≥18 years) per trial will be recruited who are newly diagnosed with OSA and speak English. * In both trials, we will purposely recruit samples balanced by biological sex and OSA severity (apnea hypopnea index: 5-14 vs. ≥ 15). * Inclusion Criteria are the same for both Aim 2 trials; Adult patients from MCCSM sites who: * Are diagnosed with OSA based on clinical diagnostic testing via laboratory or home-based sleep study; * Own and have the functional and cognitive ability to use an Apple (iOS9 or higher) or Android (4.2 or higher) smartphone with minimal to no assistance; * Are prescribed continuous or auto-titrated CPAP; * Agree to using a smartphone application and wearable wrist sensor; and * Speak and read English. Exclusion Criteria: * Unwilling to complete study measures and engage with SleepWell24; * Refuse to not use the Fitbit application during the study trial; * Have any conditions that would impede full participation (e.g., communication or cognitive impairments that limit ability to read and/or follow directions, other acute or severe health, cognitive, or psychological conditions); * Currently participating in other lifestyle programs (e.g. active, formal weight loss program or research study; smoking cessation program, etc.); * Decide to use a different PAP device than ResMed Airsense 10; * Prescribed high-dose benzodiazepines (equivalent to \> 1 mg lorazapam/night); * Daily opioid medication use at night;' * Unwilling to discontinue use of any current wearable sensor for the duration of the trial; * Previous documented history of treatment/referral for claustrophobia; * Previous CPAP use; * Currently engaging in shiftwork defined as night shift or rotating day and night shifts; and * Currently pregnant, trying to conceive, or breastfeeding.
Where this trial is running
Scottsdale, Arizona and 1 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Timothy Morgenthaler, MD — Mayo Clinic
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.