Clinical efficacy and satisfaction of a digital wheeze detector in a multicenter randomised controlled trial – the WheezeScan study

Wheezing is common in pre-school children and its clinical assessment often challenging for caretakers. This study aims to evaluate the impact of a novel digital wheeze detector (WheezeScan™, OMRON Healthcare Co. Ltd, Japan) on disease control in a home care setting.A multicenter randomised open-labeled controlled trial was conducted in Berlin, Istanbul and London. Participants aged 4–84 months with a doctor's diagnosis of recurrent wheezing in the past 12 months were included. While the control group followed usual care, the intervention group received the WheezeScan™ for at home use for 120 days. Parents completed questionnaires regarding their child's respiratory symptoms, disease-related and parental quality of life, and caretaker self-efficacy at baseline (T0), 90 days (T1), and 4 months (T2).A total of 167 children, with a mean age of 3.2 years (sd1.6), were enrolled in the study (nintervention=87; ncontrol=80). There was no statistically significant difference in wheeze control assessed by TRACK (mean difference 3.8, 95% CI −2.3–9.9; p=0.2) at T1 between treatment groups (primary outcome). Children's and parental quality of life and parental self-efficacy were comparable between both groups at T1. The evaluation of device usability and perception showed that parents found it useful.In the current study population, the wheeze detector did not show significant impact on the home management of pre-school wheezing. Hence, further research is needed to better understand how the perception and usage behavior may influence the clinical impact of a digital support.