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Completed

NCT Number: NCT06039865

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Behavior Dyssomnias Health Behavior Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Treatment Adherence and Compliance

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Greater Los Angeles Healthcare System

North Hills, California, 91343, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate intervention

Behavioral

Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.

Waitlist Control

Behavioral

Participants only receive usual care from the sleep center.

Primary outcomes

  1. 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

  1. PAP adherence (percent of days used >= 4 hours)

    Time frame: 5 weeks

    Change in the percent of days PAP was used >= 4 hours

Sponsors and collaborators

Lead sponsor

VA Greater Los Angeles Healthcare System

Fed

Collaborators

  • University of California, Los Angeles

Registry information

Official study title

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

Acronym: mPAP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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