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使用远程护理将上一代面罩更换为新一代面罩用于睡眠呼吸暂停气道正压治疗的可行性和可接受性。

Feasibility and acceptability of switching from a previous-generation to a new-generation mask for positive airway pressure therapy of sleep apnea using remote care.

作者信息

Zhu Xueling, Benjafield Adam, Deas Ross, Willes Leslee, Armitstead Jeff

机构信息

ResMed Science Center, Sydney, Australia.

Willes Consulting Group, Encinitas, CA, USA.

出版信息

Sleep Med X. 2024 Oct 11;8:100128. doi: 10.1016/j.sleepx.2024.100128. eCollection 2024 Dec 15.

Abstract

PURPOSE

Mask selection could affect an individual's experience with positive airway pressure (PAP) treatment for obstructive sleep apnea, but there is very limited data on the impact of switching to a different mask once established on PAP therapy. This study investigated the patient's experience when switching from a previous-generation PAP mask to a new-generation mask via remote care.

METHODS

A new-generation mask (AirFit F30i or AirFit N30i) was successfully fitted to 215 participants during video conferencing sessions. Participants completed online questionnaires on day 1, day 3, day 7, day 30 and day 90 after mask switch to collect subjective feedback and quality of life data; objective PAP device data were also downloaded.

RESULTS

Residual apnea-hypopnea index showed statistically significant difference from baseline at day 30 (+0.2 ± 0.9/h [p = 0.026]) and day 90 (+0.2 ± 0.8/h [p = 0.006]), however unlikely to be clinically relevant. Average daily usage was significantly increased from baseline at day 30 (+0.2 ± 1.2 h/day [p = 0.010]) but not day 90 (+0.1 ± 1.0 h/day [p = 0.126]). Functional Outcomes of Sleep Questionnaire (FOSQ-10) score was significantly higher at day 90 (change from baseline to day 90: +0.48 ± 2.29 [p = 0.015]). Subjective ratings for comfort, seal, and usability of the new-generation mask were significantly better than the predefined acceptability level. Rates of PAP-related side effects were generally acceptable.

CONCLUSION

Remote management of mask change was associated with good outcomes in terms of objective device data and patient acceptability. This approach could be used to improve the overall therapy experience for individuals requiring a PAP therapy mask change for any reason.

CLINICAL TRIAL REGISTRATION

http://clinicaltrials.gov (NCT05262439).

摘要

目的

面罩的选择可能会影响个体接受阻塞性睡眠呼吸暂停正压通气(PAP)治疗的体验,但对于在已确立PAP治疗后更换为不同面罩的影响,相关数据非常有限。本研究通过远程护理调查了患者从一代PAP面罩更换为新一代面罩时的体验。

方法

在视频会议期间,成功为215名参与者佩戴了新一代面罩(AirFit F30i或AirFit N30i)。参与者在面罩更换后的第1天、第3天、第7天、第30天和第90天完成在线问卷,以收集主观反馈和生活质量数据;同时下载客观的PAP设备数据。

结果

残余呼吸暂停低通气指数在第30天(+0.2±0.9次/小时[p = 0.026])和第90天(+0.2±0.8次/小时[p = 0.006])与基线相比有统计学显著差异,但临床相关性可能不大。第30天的平均每日使用时间较基线显著增加(+0.2±1.2小时/天[p = 0.010]),但第90天未增加(+0.1±1.0小时/天[p = 0.126])。睡眠问卷功能结局(FOSQ - 10)评分在第90天显著更高(从基线到第90天的变化:+0.48±2.29[p = 0.015])。新一代面罩在舒适度、密封性和易用性方面的主观评分显著优于预先定义的可接受水平。PAP相关副作用的发生率总体上可以接受。

结论

在客观设备数据和患者可接受性方面,远程管理面罩更换与良好的结果相关。这种方法可用于改善因任何原因需要更换PAP治疗面罩的个体的整体治疗体验。

临床试验注册

http://clinicaltrials.gov(NCT05262439)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68b8/11532967/45bb8dca415a/gr1.jpg

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