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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: Waitlist control; Behavioral: Immediate Intervention

• Registration Number: NCT06039865
• Lead Sponsor: VA Greater Los Angeles Healthcare System

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.

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Start: 2023-10-20
• Status Verified: 2025-01
• Primary Completion: 2025-01-21
• Study Completion: 2025-01-21
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist control	Waitlist control	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.
Immediate Intervention	Immediate Intervention	Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.

Primary Outcome Measures

Name	Time	Method
PAP adherence (minutes)	5 weeks	Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3).

Secondary Outcome Measures

Name	Time	Method
PAP adherence (percent of days used >= 4 hours)	5 weeks	Change in the percent of days PAP was used \>= 4 hours

Trial Locations

Locations (1)

VA Greater Los Angeles Healthcare System; 🇺🇸 North Hills, California, United States