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

Mayo Clinic

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: SleepWell24 Application

Study type: Interventional

Funder types: Other

Identifiers

NCT06381115

23-006685

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

SleepWell24 Smart Application

Experimental group

Description:

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.

Treatment:

Behavioral: SleepWell24 Application