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

NCT06381115 | Recruiting

• 1 other identifier: 23-006685
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• CPAP Adoption

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

  approximately 6 months

• Change in Quality of Life

  As measured by weekly survey asking participants to rate their health based on excellent, very good, good, fair, and poor.

  baseline, weekly assessments for approximately 6 months

Secondary Outcomes (3)

• Change in sleep time

  baseline, weekly assessments for approximately 6 months

• Change in physical activity

  baseline, weekly assessments for approximately 6 months

• Change in sedentary time

  baseline, weekly assessments for approximately 6 months

Study Arms (1)

SleepWell24 Smart Application

EXPERIMENTAL

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.

Behavioral: SleepWell24 Application

Interventions

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.

SleepWell24 Smart Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Arizona State University (ASU): collaborator

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Timothy Morgenthaler, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)