Validation of the Hyfe cough monitoring system: a multicenter clinical study (Preprint)

BACKGROUND The ability to passively and continuously monitor coughing 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. OBJECTIVE To assess the overall performance of the Hyfe Cough Monitoring System when used by individuals with problematic cough, under common living conditions 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 hours 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 hours monitored, 4454 cough events were recorded; The overall sensitivity was 90.4% (95% CI of 88.3% to 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 with OLS slope 0.94 and OLS intercept 0.68). CONCLUSIONS 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 confirm its potential role in the management of patients with cough in clinical practice. CLINICALTRIAL Clinicaltrials.gov: NCT05723159