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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381115
• Other study ID #: 23-006685
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Arizona State University (ASU)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in sleep time	As measured by the Fitbit Charge 4 sensor, reported in hours	baseline, weekly assessments for approximately 6 months
Secondary	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
Secondary	Change in sedentary time	As measured by the Fitbit Charge 4 sensor, reported in hours	baseline, weekly assessments for approximately 6 months