Clinical trial NCT06381115: App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
Official title: An App-Based, Precision Medicine Approach to Optimize Long-Term CPAP Adherence and Quality of Life
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Arizona State University (ASU)
First posted: 2024-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: CPAP Adoption
timeFrame: approximately 6 months
measure: Change in Quality of Life
timeFrame: baseline, weekly assessments for approximately 6 months
Secondary outcomes:
measure: Change in sleep time
timeFrame: baseline, weekly assessments for approximately 6 months
measure: Change in physical activity
timeFrame: baseline, weekly assessments for approximately 6 months
measure: Change in sedentary time
timeFrame: baseline, weekly assessments for approximately 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Timothy Morgenthaler, MD
role: PRINCIPAL_INVESTIGATOR
References: