Hyfe is delighted to announce that our category-defining cough-monitoring technology is now available on Actigraph’s LEAP wearable for use in clinical trials (press release).
This partnership advances research by enabling the collection of accurate, continuous cough frequency data on Actigraph’s FDA-cleared medical-grade LEAP wearable alongside digital measures including heart rate, sleep, movement, and oxygen saturation. The Hyfe cough algorithms, widely used in more than 50 studies to date, provide a timestamp of each cough with millisecond accuracy, enabling detailed analysis of cough rates and bouts. Via this partnership, composite metrics, where cough is analysed alongside other digital biomarkers, will be available for the first time.
Cough is an important symptom across many therapeutic areas including COPD, asthma, IPF/ILD and chronic cough, yet it has historically been difficult to measure which has limited its utility as a biomarker in clinical trials. Traditional approaches, such as patient-reported outcomes or short-term audio recordings (typically maximum 24h or limited to nighttime), have provided incomplete data, hindering insights into disease progression and treatment efficacy. Cough has been shown to be highly variable day-to-day (ref), meaning long-term monitoring is critical to accurately assess cough trends. For long-term monitoring to be acceptable to patients, it has to be passive and privacy-preserving.
Hyfe’s validated technology addresses these challenges by offering AI-powered continuous cough monitoring. Hyfe’s research tools have been used in dozens of investigator-initiated and sponsor-led studies, from proof-of-concepts to Phase 2b trials, to real-world-evidence studies. This partnership with Actigraph makes long-term cough-monitoring even more widely available.
The integration of Hyfe’s algorithms with ActiGraph’s LEAP wearable creates a comprehensive digital health solution for clinical trial sponsors, CROs, and researchers. This partnership allows:
Hyfe’s technology remains available directly to sponsors conducting cough-focused studies, ensuring that researchers retain access to cutting-edge solutions tailored to their needs. This partnership further extends the reach of Hyfe’s technology, making it easier to incorporate into clinical trials in a wide variety of indications.
