RecruitingNot ApplicableNCT06381115

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

An App-Based, Precision Medicine Approach to Optimize Long-Term CPAP Adherence and Quality of Life

Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Obstructive Sleep Apnea

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

Min Age: 18 Years

Inclusion Criteria7

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).
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 Criteria12

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.

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Interventions

BEHAVIORALSleepWell24 Application

The SleepWell24 application will use connections with a Shelly smart plug and a Fitbit Charge 4 along with weekly questionnaires to monitor CPAP usage.

Locations(2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT06381115

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