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远程监测系统支持阻塞性睡眠呼吸暂停患者的气道正压治疗:一项多中心随机对照试验。

Remote monitoring system to support positive airway pressure therapy in patients with obstructive sleep apnea: a multi-center randomized controlled trial.

机构信息

Department of Medical Informatics, School of Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, 91779-48564, Iran.

Department of Computer Engineering, Faculty of Industry and Mining, University of Sistan and Baluchestan, Zahedan, Iran.

出版信息

Sleep Breath. 2024 Dec;28(6):2759-2773. doi: 10.1007/s11325-024-03108-y. Epub 2024 Aug 28.

DOI:10.1007/s11325-024-03108-y
PMID:39196315
Abstract

PURPOSE

To develop and evaluate an intervention tailored to patients' needs to increase the rate of positive airway pressure (PAP) adherence in patients afflicted with obstructive sleep apnea (OSA), who undergo PAP therapy.

METHODS

A multi-center, 3 parallel-arm, randomized, controlled trial was conducted. Participants with OSA who undergo a PAP therapy were randomized to one of three groups: control arm (usual care), educational booklet arm, and mobile-based application arm. PAP usage, the percentage of days using the device for more than 4 h, change in knowledge, risk perception, outcome expectancy, self-efficacy, and ESS were assessed before and one month after interventions in the three groups. Also, the application usage data were analyzed.

RESULTS

The result showed the change in average PAP usage, knowledge, risk perception, and self-efficacy in the application group was significantly higher than the control and booklet groups. Also, the change in use for more than 4 h in the application group was significantly higher than the control group. Comparing the actual and patients' self-report PAP use indicated patients' self-report about the use of the device is about 50 min (0.8 h) more than the actual amount of use.

CONCLUSION

The study results indicated that the improvement of primary and secondary outcomes in adherence to PAP was significantly higher in the application group than in other study groups. Given the increasingly penetrating influence of smartphone-based technologies, it seems that mobile-based applications could potentially be adopted in the population of patients with OSA.

CLINICAL TRIALS REGISTRATION

IRCT2017092236314N1; https://en.irct.ir/trial/27185.

摘要

目的

开发并评估一项针对患者需求的干预措施,以提高阻塞性睡眠呼吸暂停(OSA)患者接受持续气道正压通气(PAP)治疗时的PAP 依从率。

方法

开展了一项多中心、3 臂平行、随机对照试验。将接受 PAP 治疗的 OSA 患者随机分为 3 组:对照组(常规护理)、教育手册组和基于移动应用程序组。在干预前和干预后 1 个月,评估 3 组患者的 PAP 使用情况、设备使用 4 小时以上的天数百分比、知识变化、风险感知、结果预期、自我效能和 ESS,同时分析应用程序使用数据。

结果

结果显示,应用程序组的平均 PAP 使用量、知识、风险感知和自我效能的变化明显高于对照组和手册组。此外,应用程序组使用超过 4 小时的变化明显高于对照组。比较实际和患者自我报告的 PAP 使用情况表明,患者自我报告的设备使用时间比实际使用时间长约 50 分钟(0.8 小时)。

结论

研究结果表明,应用程序组在 PAP 依从性的主要和次要结局的改善方面明显高于其他研究组。鉴于智能手机技术的影响力越来越大,基于移动应用程序的方法可能会在 OSA 患者人群中得到采用。

临床试验注册

IRCT2017092236314N1;https://en.irct.ir/trial/27185.

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