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

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.
Competing Interests: Declarations. Competing interests: MR, MG, LJ, MG, JB, GK and PS are employees of Hyfe, Inc and own equity in Hyfe Inc. CCh has received consultancy fees and owns equity in Hyfe Inc. All other authors declare no conflict of interest.
(© 2025. The Author(s).)