Clinical meaningfulness

Evidence of cough quantification’s clinical meaningfulness and utility is growing, largely through independent investigations using Hyfe’s technology.

Birring, S. S., Fleming, T., Matos, S., Raj, A. A., Evans, D. H., & Pavord, I. D. (2008). The Leicester Cough Monitor: Preliminary validation of an automated cough detection system in chronic cough. European Respiratory Journal, 31(5), 1013–1018. https://doi.org/10.1183/09031936.00057407
- This foundational validation study established that an automated 24-hour cough monitoring device can reliably count coughs in chronic cough patients
- The Leicester Cough Monitor demonstrated high sensitivity (~91%) and specificity (~99%) for detecting cough events and produced repeatable cough frequency measurements
- The authors concluded that objective cough counts provide a useful clinical outcome measure for assessing cough severity and response in clinical trials and longitudinal studies

Hall, J. I., Lozano, M., Estrada-Petrocelli, L., Birring, S. S., & Turner, R. (2020). The present and future of cough counting tools. Journal of Thoracic Disease, 12(9), 5207–5223. https://doi.org/10.21037/jtd-2020-icc-003
- This review outlines how technological advances have made objective cough frequency an increasingly important measure in respiratory disease
- Hall et al. note that cough count is now the gold-standard primary endpoint in clinical trials for new chronic cough treatments and has been explored as a marker of tuberculosis infectiousness and as an indicator of recovery in COPD exacerbations pubmed
- They predict that improved automated detection (leveraging techniques like speech recognition and ubiquitous mobile devices) will soon allow cough counting to transition from a niche research tool into a widely adopted method for clinical assessment and monitoring of respiratory conditions.

Turner, R. D., & Birring, S. S. (2023). Measuring cough: what really matters? Journal of Thoracic Disease, 15(4), 2288–2299. https://doi.org/10.21037/jtd-23-230
- Turner and Birring provide a comprehensive overview of cough measurement techniques, emphasizing that objective cough frequency has become a key outcome in clinical research, particularly serving as the primary endpoint in trials of new anti-cough therapies
- They explain that technology is enabling wider use of automated cough counters, which complement traditional patient-reported measures (like symptom scores and quality-of-life questionnaires) by providing quantitative data on cough frequency
- The review underscores that combining subjective and objective measures offers a more complete assessment of a patient’s cough, reflecting both the perceived impact and the actual cough frequency.

Zimmer, A. J., Das, R., Espinoza Lopez, P., Nafade, V., Gore, G., Ugarte-Gil, C., Chung, K. F., Song, W. J., Pai, M., & Grandjean Lapierre, S. (2025). Objective cough counting in clinical practice and public health: A scoping review. The Lancet Digital Health. Advance online publication. https://doi.org/10.1016/j.landig.2025.100908
- Zimmer et al. conducted a scoping review of how objective cough monitoring is used in patient care and public health. They identified five key applications for cough counts — disease diagnosis, severity assessment, treatment monitoring, health outcome prediction, and syndromic surveillance — but found scarce evidence supporting each use case to date.
- The review noted moderate correlations between recorded cough frequency and patients’ reported cough severity and quality of life, suggesting that while cough counts capture clinically relevant information, they do not always align with subjective symptom experience.
- The authors highlight the potential value of cough counting for managing respiratory diseases, but also point out practical challenges (device obtrusiveness, adherence, privacy concerns) and call for more studies to validate and integrate cough counting tools into real-world clinical practice.

Chaccour, C., Sánchez-Olivieri, I., Siegel, S., Megson, G., Winthrop, K. L., Botella, J. B., de-Torres, J. P., Jover, L., Brew, J., Kafentzis, G., Galvosas, M., Rudd, M., & Small, P. (2025). Validation and accuracy of the Hyfe CoughMonitor system: A multicenter clinical study. Scientific Reports, 15, 880. https://doi.org/10.1038/s41598-025-85341-3
- In this multicenter study, Chaccour et al. validated a wearable automated cough counter (the Hyfe CoughMonitor) against manual cough counts. The device detected cough events with ~90% sensitivity and a very low false-positive rate (~1 per hour), and its hourly cough counts showed near-perfect correlation with human counters (Pearson r ≈ 0.99) .
- The results demonstrate that a non-intrusive, fully automated monitor can reliably track cough frequency as patients go about their daily activities. Given that cough is one of the most common medical symptoms and is associated with outcomes in diseases like COPD and COVID-19, this validated tool paves the way for incorporating objective cough counting into routine clinical practice. The authors suggest that such technology could improve diagnosis and treatment monitoring for chronic cough and other respiratory conditions, helping clinicians objectively assess cough severity and response to therapy.