Evaluating the User Experience of a Novel Positive Airway Pressure Therapy Device for Treating Obstructive Sleep Apnea in the Home Environment

S. Herath, A. Middleton, X. Zhu, R. Deas, J. Armitstead, ResMed Science Center, ResMed Ltd, Sydney, Austral, ResMed Science Center, ResMed Corp., San Diego, Ca
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Abstract

RATIONALE : Treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP) therapy is well accepted. Despite its well documented efficacy, adherence remains an obstacle for optimal patient outcomes. Favorable user experience is predicted to positively impact adherence. Van Ryswyk et al. (2019), concluded that early CPAP adherence can be a predictive value to identify those at highest risk of non-adherence to long-term CPAP therapy. This multi-center, single arm study aims to assess the user experience of a novel PAP device (AirSense 11, ResMed Ltd, Sydney, Australia) in comparison to AirSense 10 (ResMed Ltd, Sydney, Australia) in the home environment. The AirSense 11 device is distinguished by an improved touchscreen user interface and ergonomic design features. METHODS : Surveys were distributed to gather feedback on user experience of AirSense 11 and AirSense 10, over 7 nights in the home environment. Those enrolled were experienced PAP users established on the AirSense 10 device. The study was executed in two key phases;the first in Sydney, Australia and second in San Diego, USA. Ethics approval was obtained for both sites and the study is registered with clinicaltrials.gov (NCT04744038). A telehealth component was introduced to the US cohort at the initial setup to adhere to COVID-19 mandates. RESULTS : Efficacy data extracted from the device recordings showed no significant difference in parameters of AHI, leak, pressures and usage. Surveys were completed by 108 evaluable study participants. Data could not be combined across both sites for all categories due to changes made in the user interface between Sydney and San Diego. The data obtained from the surveys yielded insights into ease of use, ease of use of the tube, ease of starting therapy, confidence in setting up the device in the home environment, breathing comfort, noise, humidification performance and overall performance (Figure 1). Ratings for ease of starting therapy, breathing comfort, noise and humidification performance were significantly better on AirSense 11. No significance was found in other categories. Continued analysis of the data will provide further insights between AirSense 10 and AirSense 11. CONCLUSION : The results of this analysis indicate that both PAP devices preformed well in the home environment. However AirSense 11 showed superiority in areas such as ease of starting therapy, breathing comfort, noise and humification performance. Improvements to initial user experience may lead to improved short- and long-term compliance. Future studies will utilize telemonitoring capabilities to explore these outcomes. (Table Presented).
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评估一种新型气道正压治疗设备在家庭环境中治疗阻塞性睡眠呼吸暂停的用户体验
原理:气道正压通气(PAP)治疗阻塞性睡眠呼吸暂停(OSA)已被广泛接受。尽管疗效良好,但依从性仍然是最佳患者预后的障碍。预期良好的用户体验会对依从性产生积极影响。Van Ryswyk等人(2019)得出结论,早期CPAP依从性可以作为识别长期CPAP治疗不依从性风险最高的预测价值。这项多中心、单臂研究旨在评估一种新型PAP设备(AirSense 11, ResMed Ltd, Sydney, Australia)与AirSense 10 (ResMed Ltd, Sydney, Australia)在家庭环境中的用户体验。AirSense 11的特点是改进的触摸屏用户界面和符合人体工程学的设计特点。方法:通过调查收集用户对AirSense 11和AirSense 10在家庭环境中7晚的使用体验反馈。这些参与者是在AirSense 10设备上建立的经验丰富的PAP用户。这项研究分两个关键阶段进行,第一阶段在澳大利亚悉尼,第二阶段在美国圣地亚哥。该研究已在clinicaltrials.gov注册(NCT04744038)。在最初的设置中,美国队列中引入了远程医疗组件,以遵守COVID-19的要求。结果:从器械记录中提取的疗效数据显示,AHI、泄漏、压力和使用等参数无显著差异。108名可评估的研究参与者完成了调查。由于悉尼和圣地亚哥之间的用户界面发生了变化,因此无法跨两个站点合并所有类别的数据。从调查中获得的数据产生了对易用性、管的易用性、开始治疗的易用性、在家庭环境中设置设备的信心、呼吸舒适性、噪音、加湿性能和整体性能的见解(图1)。在AirSense 11上,开始治疗的易用性、呼吸舒适性、噪音和加湿性能的评分明显更好。在其他类别中没有发现显著性。对数据的持续分析将提供AirSense 10和AirSense 11之间的进一步见解。结论:本分析结果表明,两种PAP设备在家庭环境中表现良好。然而,AirSense 11在开始治疗的便利性、呼吸舒适性、噪音和腐殖质性能等方面表现出优势。对初始用户体验的改进可能会改善短期和长期的遵从性。未来的研究将利用远程监测功能来探索这些结果。(表)。
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