White Paper

Continuous Cough Monitoring: Addressing Placebo Effects And Data Gaps in Clinical Studies

GettyImages-912073314 In Home Nurse

Traditional clinical trials often overlook the rich, dynamic aspects of patients’ daily experiences, capturing only brief snapshots during study visits. This limited view creates critical data gaps—especially for symptoms like cough—that affect patient quality of life and therapeutic outcomes. Emerging digital health technologies, such as the ActiGraph LEAP® multisensor wearable combined with Hyfe’s AI-powered cough detection algorithms, offer a more continuous, objective view of respiratory health. By passively and securely monitoring coughs in real-world environments, these tools deliver richer, more accurate data that can help close these gaps.

One major area of need is addressing placebo effects in chronic cough trials. Continuous cough monitoring provides a way to track natural symptom variability, select more consistent patients, and correlate objective data with subjective experience, reducing placebo-driven noise. Early studies with the LEAP device and Hyfe’s AI algorithms show high accuracy in cough detection while safeguarding patient privacy. This holistic approach allows researchers to better understand how cough interacts with sleep, physical activity, and other health domains, providing a clearer view of disease progression and treatment effects across respiratory and cardiovascular conditions. Modernizing symptom monitoring in this way is essential to improving clinical trial quality and real-world therapeutic decision-making.

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Ametris (formerly ActiGraph)