This pivotal trial evaluated the RESP® System as a wearable auscultation device in children, marking its first validation in a pediatric population. Thirty-three subjects were enrolled at Lurie Children’s, including 30 with asthma exacerbations and three controls. The RESP device recorded breath sounds from the chest while a recording stethoscope collected simultaneous control data, which were later reviewed by a blinded attending physician. Sensitivity and specificity for wheeze detection were calculated, alongside usability and tolerability assessments.

The RESP System demonstrated excellent sensitivity for wheeze detection, with specificity limited in part by the inherent variability of physician auscultation as the gold standard. Sensitivity improved when auscultation was performed across multiple chest areas. Usability testing showed high scores on the System Usability Scale (81.8 overall, 83.6 among independent users), and all participants reported the system was easy to use, comfortable, and something they would recommend to others.

These results validate the RESP System as a sensitive, user-friendly tool for detecting wheezing in children with asthma, supporting its potential use in both clinical care and home monitoring.