Introduction: Wheezing is a common condition in pre-school children and parental management of the disease may be supported by digital health technologies. This study aims to evaluate the impact of a commercially available digital wheeze detector (WheezeScan, Omron Healthcare, Japan) on clinical parameters.  
Methods: A multicenter randomized controlled trial was conducted in Berlin, London and Istanbul. Children aged 4-84 months with a doctor?s diagnosis of recurrrent wheeze were recruited. The control group followed usual care, and the intervention group received the WheezeScan device to be used at home. Parents completed questionnaires regarding their child?s respiratory symptoms, quality of life and parental self-efficacy at baseline and follow-up visits (0,3,4 months). The trial was registered (DRKS00026740) and approved by all local ethics committees.
Results: A total of 167 children, with a mean age of 3.29 years (SD 1.6), were recruited. Evaluation of the device?s usability and perception showed that parents generally found it useful, although satisfaction levels varied significantly among the different study centers. There were no statistically significant improvements in asthma control (mean diff. 3.8, 95% CI -2.3-9.9; p=0.2), children?s and parental quality of life or parental self-efficacy (mean diff. -0.8, 95% CI -3.7-2.0; p=0.6).

Conclusion: In the current study population and settings, the wheeze detector was generally well accepted by parents, but did not show significant impact on the management of pre-school wheezing disorders at home. Further research is needed to enhance device usability and understand parental perception of the novel device.