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Hyfe咳嗽监测系统的验证与准确性:一项多中心临床研究。

Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study.

作者信息

Chaccour Carlos, Sánchez-Olivieri Isabel, Siegel Sarah, Megson Gina, Winthrop Kevin L, Botella Juan Berto, de-Torres Juan P, Jover Lola, Brew Joe, Kafentzis George, Galvosas Mindaugas, Rudd Matthew, Small Peter

机构信息

ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain.

Navarra University Clinic, Pamplona, Spain.

出版信息

Sci Rep. 2025 Jan 6;15(1):880. doi: 10.1038/s41598-025-85341-3.

DOI:10.1038/s41598-025-85341-3
PMID:39762316
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11704278/
Abstract

BACKGROUND

The ability to passively and continuously monitor coughing for prolonged periods of time would significantly improve cough management and research. To date there is no automated clinically validated cough monitor that can be routinely used in clinical care and research. Here we describe the validation of such an automated cough monitor.

METHODS

This multicenter observational study compared the results of the Hyfe CoughMonitor wrist-worn device with manually counted coughs in subjects with a variety of etiologies as they went about their usual daily activities. We collected 24 h of continuous sounds from subjects while they simultaneously wore a CoughMonitor and an audio recorder. Coughs were labelled by multiple trained annotators who listened to the continuous audio recordings using validated methodology. The time stamps of these human-detected coughs were compared to those of the CoughMonitor to determine the system's overall performance using event-to-event and hourly rate correlation analyses.

RESULTS

Over the 546 h monitored, 4,454 cough events were recorded; The overall sensitivity was 90.4% (95% CI of 88.3-92.2%). The overall false positive rate was 1.03 false positives per hour (95% CI of 0.84 to 1.24). The overall correlation between manual and CoughMonitor measured hourly coughing was high (Pearson correlation coefficient of 0.99). Two case studies of long-term monitoring of patients with chronic cough are presented.

CONCLUSION

The present analysis of cough events demonstrated that the Hyfe CoughMonitor accurately reflects them with a high sensitivity and a low false positive rate. Future studies should focus on its potential role in the management of patients with cough in clinical practice.Registration Clinicaltrials.gov, NCT05723159.

摘要

背景

能够长时间被动且持续地监测咳嗽,将显著改善咳嗽的管理与研究。迄今为止,尚无经过临床验证的自动化咳嗽监测仪可常规用于临床护理和研究。在此,我们描述了这样一种自动化咳嗽监测仪的验证情况。

方法

这项多中心观察性研究,将Hyfe咳嗽监测仪腕戴式设备的结果,与患有各种病因的受试者在日常活动时人工计数的咳嗽次数进行了比较。我们在受试者同时佩戴咳嗽监测仪和录音机时,收集了他们24小时的连续声音。咳嗽由多名经过培训的注释者使用经过验证的方法,通过收听连续音频记录来进行标记。将这些人工检测到的咳嗽的时间戳与咳嗽监测仪的时间戳进行比较,以使用逐事件和每小时发生率相关性分析来确定系统的整体性能。

结果

在监测的546小时内,记录了4454次咳嗽事件;总体灵敏度为90.4%(95%置信区间为88.3 - 92.2%)。总体假阳性率为每小时1.03次假阳性(95%置信区间为0.84至1.24)。人工计数和咳嗽监测仪测量的每小时咳嗽次数之间的总体相关性很高(Pearson相关系数为0.99)。展示了两个慢性咳嗽患者长期监测的案例研究。

结论

目前对咳嗽事件的分析表明,Hyfe咳嗽监测仪以高灵敏度和低假阳性率准确反映了咳嗽事件。未来的研究应关注其在临床实践中对咳嗽患者管理的潜在作用。注册Clinicaltrials.gov,NCT05723159。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/fe5becf04f1f/41598_2025_85341_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/34170ad234a9/41598_2025_85341_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/39e15e75b736/41598_2025_85341_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/8ff03d53d939/41598_2025_85341_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/200e5e97ffc9/41598_2025_85341_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/fe5becf04f1f/41598_2025_85341_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/34170ad234a9/41598_2025_85341_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/39e15e75b736/41598_2025_85341_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/8ff03d53d939/41598_2025_85341_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/200e5e97ffc9/41598_2025_85341_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f4e/11704278/fe5becf04f1f/41598_2025_85341_Fig5_HTML.jpg

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