Recruiting

CPAP with SmartWell24

Sponsor:

Mayo Clinic

Code:

NCT06381115

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SleepWell24 Application

Study Details

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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT06381115

Start date

Jun 1, 2025

Status verified date

Aug, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SleepWell24 Smart 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.

Interventions

SleepWell24 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.

Primary outcome measure

  • CPAP Adoption [ Time Frame: approximately 6 months ]
  • Change in Quality of Life [ Time Frame: baseline, weekly assessments for approximately 6 months ]

Central Contacts and Locations

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Betty Monari

480-574-2641Monari.Betty@mayo.edu

Principal Investigator:

Umesh Goswami, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Rebecca K Ra

507-284-2122ra.rebecca@mayo.edu

Principal Investigator:

Timothy Morgenthaler, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.