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New treatment option for Obstructive Sleep Apnea
Official title App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
ClinicalTrials.gov ID: NCT06381115
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
- 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...
You likely can't join if
- 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...
- 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);
See the full eligibility 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).
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.