App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT06381115
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> - In both trials of Aim 2, twenty adults (=18 years) per trial will be recruited who<br> are newly diagnosed with OSA and speak English.<br><br> - In both trials, we will purposely recruit samples balanced by biological sex and OSA<br> severity (apnea hypopnea index: 5-14 vs. = 15).<br><br> - Inclusion Criteria are the same for both Aim 2 trials; Adult patients from MCCSM<br> sites who:<br><br> - Are diagnosed with OSA based on clinical diagnostic testing via laboratory or<br> home-based sleep study;<br><br> - Own and have the functional and cognitive ability to use an Apple (iOS9 or<br> higher) or Android (4.2 or higher) smartphone with minimal to no assistance;<br><br> - Are prescribed continuous or auto-titrated CPAP;<br><br> - Agree to using a smartphone application and wearable wrist sensor; and<br><br> - Speak and read English.<br><br>Exclusion Criteria:<br><br> - Unwilling to complete study measures and engage with SleepWell24;<br><br> - Refuse to not use the Fitbit application during the study trial;<br><br> - Have any conditions that would impede full participation (e.g., communication or<br> cognitive impairments that limit ability to read and/or follow directions, other<br> acute or severe health, cognitive, or psychological conditions);<br><br> - Currently participating in other lifestyle programs (e.g. active, formal weight loss<br> program or research study; smoking cessation program, etc.);<br><br> - Decide to use a different PAP device than ResMed Airsense 10;<br><br> - Prescribed high-dose benzodiazepines (equivalent to > 1 mg lorazapam/night);<br><br> - Daily opioid medication use at night;'<br><br> - Unwilling to discontinue use of any current wearable sensor for the duration of the<br> trial;<br><br> - Previous documented history of treatment/referral for claustrophobia;<br><br> - Previous CPAP use;<br><br> - Currently engaging in shiftwork defined as night shift or rotating day and night<br> shifts; and<br><br> - Currently pregnant, trying to conceive, or breastfeeding.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CPAP Adoption;Change in Quality of Life
- Secondary Outcome Measures
Name Time Method Change in sleep time;Change in physical activity;Change in sedentary time