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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized to immediate versus waitlist control in a 1:1 ratio. Our project is at the forefront of consumer wearable research, leveraging the recent capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover new ways to promote PAP usage among patients with obstructive sleep apnea.

Official Title
-----------------
Augmenting Obstructive Sleep Apnea Chronic Care Management With Consumer Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Behavioral: Immediate Intervention
* Behavioral: Waitlist control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks. | Behavioral: Immediate Intervention<br>* Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.<br>|
| Other: Waitlist control<br>Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks. | Behavioral: Waitlist control<br>* Participants only receive usual care from the sleep center.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAP adherence (minutes) | Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3). | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAP adherence (percent of days used >= 4 hours) | Change in the percent of days PAP was used >= 4 hours | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wearable, Pulse oximetry, Sleep apnea, Treatment adherence