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

Mayo Clinic40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

SleepWell24 ApplicationBEHAVIORAL

The SleepWell24 application will use connections with a Shelly smart plug and a Fitbit Charge 4 along with weekly questionnaires to monitor CPAP usage.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

CPAP Adoption

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

Time frame: 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.

Time frame: baseline, weekly assessments for approximately 6 months

Secondary Outcomes

Change in sleep time

As measured by the Fitbit Charge 4 sensor, reported in hours

Time frame: 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

Time frame: baseline, weekly assessments for approximately 6 months

Change in sedentary time

As measured by the Fitbit Charge 4 sensor, reported in hours

Time frame: baseline, weekly assessments for approximately 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.