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NCT Number: NCT06381115

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SleepWell24 Application

Behavioral

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

Primary outcomes

  1. CPAP Adoption

    Time frame: approximately 6 months

    The Shelly smart plug will be used to monitor the amount of CPAP time usage by the amount of wattage recorded.

  2. Change in Quality of Life

    Time frame: 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 outcomes

  1. Change in sleep time

    Time frame: baseline, weekly assessments for approximately 6 months

    As measured by the Fitbit Charge 4 sensor, reported in hours

  2. Change in physical activity

    Time frame: baseline, weekly assessments for approximately 6 months

    As measured by the Fitbit Charge 4 sensor step count, reported as number of steps taken daily

  3. Change in sedentary time

    Time frame: baseline, weekly assessments for approximately 6 months

    As measured by the Fitbit Charge 4 sensor, reported in hours

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Arizona State University (ASU)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2024
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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