App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Behavioral: SleepWell24 Application
- Registration Number
- NCT06381115
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
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In both trials of Aim 2, twenty adults (≥18 years) per trial will be recruited who are newly diagnosed with OSA and speak English.
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In both trials, we will purposely recruit samples balanced by biological sex and OSA severity (apnea hypopnea index: 5-14 vs. ≥ 15).
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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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SleepWell24 Smart Application SleepWell24 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.
- Primary Outcome Measures
Name Time Method CPAP Adoption approximately 6 months The Shelly smart plug will be used to monitor the amount of CPAP time usage by the amount of wattage recorded.
Change in Quality of Life baseline, weekly assessments for approximately 6 months As measured by weekly survey asking participants to rate their health based on excellent, very good, good, fair, and poor.
- Secondary Outcome Measures
Name Time Method Change in sleep time baseline, weekly assessments for approximately 6 months As measured by the Fitbit Charge 4 sensor, reported in hours
Change in physical activity baseline, weekly assessments for approximately 6 months As measured by the Fitbit Charge 4 sensor step count, reported as number of steps taken daily
Change in sedentary time baseline, weekly assessments for approximately 6 months As measured by the Fitbit Charge 4 sensor, reported in hours
Trial Locations
- Locations (2)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States