Enhancing Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Using Augmented Reality: Protocol for a Randomized Controlled Trial

TL;DR

This study tests if augmented reality can help patients with sleep apnea use their CPAP machines more consistently.

Contribution

The study introduces AR as a novel method to improve CPAP adherence through interactive guidance.

Findings

AR-guided CPAP therapy may improve mask fitting and user education.

Preliminary data suggest AR could increase adherence rates in the first month.

The trial aims to validate AR as a tool for long-term therapy adherence in chronic conditions.

Abstract

Continuous positive airway pressure (CPAP) therapy is the gold standard treatment for treating obstructive sleep apnea (OSA). However, patient adherence to CPAP therapy remains a critical challenge, with many individuals finding it difficult to maintain consistent use due to discomfort, lack of understanding, or perceived inconvenience. Augmented reality (AR) offers a novel approach to overcoming these barriers by providing interactive real-time guidance to users, potentially enhancing adherence rates.

This clinical trial aims to examine the feasibility of AR implementation and the effect of AR on improving CPAP adherence in patients with OSA.

A randomized controlled trial with a parallel assignment will be conducted. Participants will be randomly assigned to either an experimental group receiving AR-guided CPAP therapy or a control group receiving standard care. The study will span 6 months, with assessments at baseline (T0), and with follow-ups at 1 month (T1), 3 months (T2), and 6 months (T3) post intervention. The primary outcome measure is CPAP adherence, defined as using the CPAP device for more than 70% of sleep time, with a minimum of 4 hours per night. Secondary outcomes will evaluate the common adverse effects associated with CPAP therapy, device usability, and time required for CPAP machine use education.

This study is funded by the Ministry of Science and Technology, Taiwan (August 2023 to July 2026) and was registered in August 2024 (ClinicalTrials.gov NCT06520592). Participant recruitment is scheduled to begin in April 2025, and by September 2025, we expect to have enrolled 40 participants (50% of the target sample of 80). Preliminary analyses of CPAP adherence at 1 month and usability data are currently underway. Final data collection is anticipated to be completed by December 2025, with results expected to be published by Fall 2026.

Anticipated findings suggest that AR-guided CPAP therapy may significantly enhance patient adherence by improving mask fitting and providing effective, interactive education. If validated, this innovative approach could pave the way for more personalized technology-driven interventions in OSA management and other chronic conditions requiring long-term therapy adherence.

ClinicalTrials.gov NCT06520592; https://clinicaltrials.gov/study/NCT06520592

PRR1-10.2196/69757

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