CompletedNot Applicable

Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial

United States50 participantsStarted 2023-10-20

Plain-language summary

The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to participants). The main question is to learn whether participants' use of positive airway pressure therapy will differ between the participants who receive the new program immediately versus delayed. Participants assigned to the delayed program will receive usual care while waiting for the program to begin.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Prescribed PAP therapy from the sleep center for \> 1 week * Have an active profile in our Center's ResMed AirView or Respironics Care Orchestrator accounts for \> 1 week * Non-adherent with PAP therapy * Willing to continue using current PAP device for 28 days continuously * Have an electronic device compatible with the wearable app Exclusion Criteria: * Diagnosis of heart failure, chronic lung disease, dementia, active substance use disorder * Use home oxygen * Unstable medical or psychiatric illness * Planned non-use of PAP therapy (e.g., waiting for replacement of recalled PAP device) * Planned surgery or hospitalization during study period * Planned extensive travel during study period * History of repeated non-attendance at clinic visits

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in PAP Adherence (Minutes) From Baseline to Post-treatment (T3)

Timeframe: 5 weeks

Trial details

NCT IDNCT06039865

SponsorVA Greater Los Angeles Healthcare System

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-01-21

Results submitted2026-07-07

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials