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Clinical Trials/NCT06039865
NCT06039865
Completed
Not Applicable

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

VA Greater Los Angeles Healthcare System1 site in 1 country50 target enrollmentOctober 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
VA Greater Los Angeles Healthcare System
Enrollment
50
Locations
1
Primary Endpoint
PAP adherence (minutes)
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2023
End Date
January 21, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
VA Greater Los Angeles Healthcare System
Responsible Party
Principal Investigator
Principal Investigator

Constance Fung

Principal Investigator

VA Greater Los Angeles Healthcare System

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

Outcomes

Primary Outcomes

PAP adherence (minutes)

Time Frame: 5 weeks

Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3).

Secondary Outcomes

  • PAP adherence (percent of days used >= 4 hours)(5 weeks)

Study Sites (1)

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