Obstructive Sleep Apnea
Conditions
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.
Interventions
BEHAVIORALSleepWell24 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.
Sponsors
Mayo Clinic
Arizona State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP Adoption | approximately 6 months | The Shelly smart plug will be used to monitor the amount of CPAP time usage by the amount of wattage recorded. |
| Change in Quality of Life | baseline, weekly assessments for approximately 6 months | As measured by weekly survey asking participants to rate their health based on excellent, very good, good, fair, and poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep time | baseline, weekly assessments for approximately 6 months | As measured by the Fitbit Charge 4 sensor, reported in hours |
| Change in physical activity | baseline, weekly assessments for approximately 6 months | As measured by the Fitbit Charge 4 sensor step count, reported as number of steps taken daily |
| Change in sedentary time | baseline, weekly assessments for approximately 6 months | As measured by the Fitbit Charge 4 sensor, reported in hours |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTimothy Morgenthaler, MD
Mayo Clinic
Outcome results
None listed