App-Based Optimization of Long-Term CPAP Adherence and Quality of Life

Recruiting now · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT06381115

Run by

Mayo Clinic

People needed

40

Starts

2025-06-01

Expected to finish

2026-07-01

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States (enrolling)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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