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

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...

Full description

Saved in:
Bibliographic Details
Main Authors: Carlos Chaccour, Isabel Sánchez-Olivieri, Sarah Siegel, Gina Megson, Kevin L. Winthrop, Juan Berto Botella, Juan P. de-Torres, Lola Jover, Joe Brew, George Kafentzis, Mindaugas Galvosas, Matthew Rudd, Peter Small
Format: Article
Language:English
Published: Nature Portfolio 2025-01-01
Series:Scientific Reports
Online Access:https://doi.org/10.1038/s41598-025-85341-3
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1841544769416724480
author Carlos Chaccour
Isabel Sánchez-Olivieri
Sarah Siegel
Gina Megson
Kevin L. Winthrop
Juan Berto Botella
Juan P. de-Torres
Lola Jover
Joe Brew
George Kafentzis
Mindaugas Galvosas
Matthew Rudd
Peter Small
author_facet Carlos Chaccour
Isabel Sánchez-Olivieri
Sarah Siegel
Gina Megson
Kevin L. Winthrop
Juan Berto Botella
Juan P. de-Torres
Lola Jover
Joe Brew
George Kafentzis
Mindaugas Galvosas
Matthew Rudd
Peter Small
author_sort Carlos Chaccour
collection DOAJ
description 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.
format Article
id doaj-art-a19cc385064a4c1ebd5d233c5095ce85
institution Kabale University
issn 2045-2322
language English
publishDate 2025-01-01
publisher Nature Portfolio
record_format Article
series Scientific Reports
spelling doaj-art-a19cc385064a4c1ebd5d233c5095ce852025-01-12T12:20:03ZengNature PortfolioScientific Reports2045-23222025-01-0115111110.1038/s41598-025-85341-3Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical studyCarlos Chaccour0Isabel Sánchez-Olivieri1Sarah Siegel2Gina Megson3Kevin L. Winthrop4Juan Berto Botella5Juan P. de-Torres6Lola Jover7Joe Brew8George Kafentzis9Mindaugas Galvosas10Matthew Rudd11Peter Small12ISGlobal, Barcelona Institute for Global HealthNavarra University ClinicOregon Health Science UniversityOregon Health Science UniversityOregon Health Science UniversityNavarra University ClinicNavarra University ClinicHyfeHyfeHyfeHyfeHyfeHyfeAbstract 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.https://doi.org/10.1038/s41598-025-85341-3
spellingShingle Carlos Chaccour
Isabel Sánchez-Olivieri
Sarah Siegel
Gina Megson
Kevin L. Winthrop
Juan Berto Botella
Juan P. de-Torres
Lola Jover
Joe Brew
George Kafentzis
Mindaugas Galvosas
Matthew Rudd
Peter Small
Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study
Scientific Reports
title Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study
title_full Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study
title_fullStr Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study
title_full_unstemmed Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study
title_short Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study
title_sort validation and accuracy of the hyfe cough monitoring system a multicenter clinical study
url https://doi.org/10.1038/s41598-025-85341-3
work_keys_str_mv AT carloschaccour validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT isabelsanchezolivieri validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT sarahsiegel validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT ginamegson validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT kevinlwinthrop validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT juanbertobotella validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT juanpdetorres validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT lolajover validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT joebrew validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT georgekafentzis validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT mindaugasgalvosas validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT matthewrudd validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy
AT petersmall validationandaccuracyofthehyfecoughmonitoringsystemamulticenterclinicalstudy