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Recruiting NCT06381115

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

Conditions: Obstructive Sleep Apnea

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Mayo Clinic

Location: Mayo Clinic in Arizona Scottsdale Arizona

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.

Eligibility 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06381115). StuddyBuddy aggregates publicly available trial information.