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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: SleepWell24 Application

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Betty Monari; Phone Number: 480-574-2641; Email: Monari.Betty@mayo.edu
      • Principal Investigator: Umesh Goswami, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Timothy Morgenthaler, MD
      • Contact: Rebecca K Ra; Phone Number: 507-284-2122; Email: ra.rebecca@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep time	As measured by the Fitbit Charge 4 sensor, reported in hours	baseline, weekly assessments for approximately 6 months
Change in physical activity	As measured by the Fitbit Charge 4 sensor step count, reported as number of steps taken daily	baseline, weekly assessments for approximately 6 months
Change in sedentary time	As measured by the Fitbit Charge 4 sensor, reported in hours	baseline, weekly assessments for approximately 6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Arizona State University (ASU)
• Investigators: Principal Investigator: Timothy Morgenthaler, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 23-006685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No