WheezeScanMC
Research type
Research Study
Full title
“WheezeScanMC” A multicenter randomized controlled trial on the impact of a digital wheeze detector on asthma and wheeze control in pre-school children
IRAS ID
306704
Contact name
Abigail Whitehouse
Contact email
Sponsor organisation
Charite University
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Infections of the upper and lower airways as well as wheezing are the most frequent causes of doctor´s visits in the first three years of life. Children suffering from recurrent wheezing are usually prescribed a reliever medication (e.g. beta-sympathomimetics) and in more severe cases also anti-inflammatory controller medication (e.g. inhaled corticosteroids). While the latter is being given on a regular basis, it is often difficult for parents and caretakers to evaluate a child´s respiration in order to decide whether reliever medication should be given or not. Digital technologies have been developed to assist parents in the home management of wheezing disorders, among them a digital wheeze detector indicating within 30 seconds whether a child´s breath sounds include wheezing or not. The present randomized controlled trial aims at evaluating whether the use of such a digital detection device improves asthma control in a home care setting of pre-school wheeze. To this end, 165 children (age 4 months to 6 years) with a diagnosis of wheezing and a prescription of reliever medication will be recruited and randomized. The intervention group will receive the WheezeScan detector for a period of 4 months and will register respiratory symptoms, medication intake and the results of the device in an electronic clinical diary. The control group will receive regular care for the same and will also be asked to record symptoms and medication intake during the monitoring period via the study app. Wheezing control will be assessed after 3 months of monitoring using the validated TRACK questionnaire. Secondary outcomes will focus on quality of life, parental self-efficacy, device usability, treatment adaptation and its efficacy. The final visit will be performed 4 months after inclusion.
REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0786
Date of REC Opinion
1 Dec 2021
REC opinion
Further Information Favourable Opinion