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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Immediate Intervention; Behavioral: Waitlist control

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • North Hills, California, United States, 91343
      • VA Greater Los Angeles Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: VA Greater Los Angeles Healthcare System
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Constance H. Fung, MD, MSHS, VA Greater Los Angeles Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Actual): January 21, 2025
• Study Completion (Actual): January 21, 2025

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Treatment adherence; Sleep apnea; Wearable; Pulse oximetry
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 20233750

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No