App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
Purpose
The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence.
Condition
- Obstructive Sleep Apnea
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SleepWell24 Smart Application |
This group will consists of participates who will be on study for 8 weeks using the Sleepwell24 application. Once 20 people are enrolled on the 8 week cohort, a 6 month cohort will open up for 20 different participants. |
|
Recruiting Locations
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
Mayo Clinic in Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic