Chen Ming-Che, Chen Yen-Chin, Lin Cheng-Yu
Department of Electronic Engineering, Southern Taiwan University of Science and Technology, Tainan, Taiwan.
Department of Nursing, College of Medicine, National Sun Yat-sen University, Kaohsiung City, Taiwan.
JMIR Res Protoc. 2025 May 6;14:e69757. doi: 10.2196/69757.
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.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/69757.
持续气道正压通气（CPAP）疗法是治疗阻塞性睡眠呼吸暂停（OSA）的金标准治疗方法。然而，患者对CPAP疗法的依从性仍然是一个关键挑战，许多人由于不适、缺乏理解或感觉不便而难以持续使用。增强现实（AR）通过为用户提供交互式实时指导，提供了一种克服这些障碍的新方法，有可能提高依从率。
本临床试验旨在研究AR实施的可行性以及AR对提高OSA患者CPAP依从性的效果。
将进行一项平行分组的随机对照试验。参与者将被随机分配到接受AR引导的CPAP治疗的实验组或接受标准护理的对照组。该研究将持续6个月，在基线（T0）进行评估，并在干预后1个月（T1）、3个月（T2）和6个月（T3）进行随访。主要结局指标是CPAP依从性，定义为每晚使用CPAP设备的睡眠时间超过70%，每晚至少使用4小时。次要结局将评估与CPAP治疗相关的常见不良反应、设备可用性以及CPAP机器使用教育所需的时间。
本研究由台湾科技部资助（2023年8月至2026年7月），并于2024年8月注册（ClinicalTrials.gov NCT06520592）。计划于2025年4月开始招募参与者，到2025年9月，我们预计将招募40名参与者（目标样本80名的50%）。目前正在对1个月时的CPAP依从性和可用性数据进行初步分析。预计最终数据收集将于2025年12月完成，结果预计于2026年秋季发表。
预期结果表明，AR引导的CPAP治疗可能通过改善面罩贴合度并提供有效、交互式教育来显著提高患者依从性。如果得到验证，这种创新方法可为OSA管理及其他需要长期治疗依从性的慢性病中更个性化的技术驱动干预措施铺平道路。
ClinicalTrials.gov NCT06520592；https://clinicaltrials.gov/study/NCT06520592。
国际注册报告识别码（IRRID）：PRR1-10.2196/69757。
