A sponsor requested help testing the feasibility and usability of wearables to quantify cough in patients with respiratory diseases. ICON needed to test that the data streams from the wearables were fit-for-purpose, while capturing patient feedback and acceptance of the device.

ICON initiated a non-interventional longitudinal pilot study with general population participants, in addition to participants diagnosed with asthma, to quantify cough sounds using wearables and sensors. We implemented an end-to-end framework that aligns with CTTI recommendations on feasibility and usability testings prior to the use of technology in the study. The study tested the VitalConnect patch to capture heart rate; the novel Automated Device for Asthma Monitoring (ADAM) to capture cough, respiration rate and temperature; and, lastly, an actigraph to track activity. Combined, ICON could determine the physiological patterns around a coughing event, aiming to identify whether this data could accurately capture cough and have the potential to predict cough

The preliminary results from this ongoing study have indicated a high rate of patient compliance and positive feedback, making these devices feasible for use in a future clinical study.