|- candidate number||22292|
|- NTR Number||NTR5387|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jun-2015|
|- Secondary IDs||k15-03 |
|- Public Title||Video-analysis of asthma symptoms in children|
|- Scientific Title||Video-analysis of dyspnea in young children before and after exercise challenge testing|
|- ACRONYM||VIDEO STUDY|
|- hypothesis||We hypothesize that video-analyzed symptoms of dyspnea are a good predictor of the presence and severity of exercise-induced bronchoconstriction.|
|- Healt Condition(s) or Problem(s) studied||Asthma, Children, Video, Telemedicine |
|- Inclusion criteria||-Clinical history of asthma or suspected of having asthma.|
-Age between 4-17 years.
-Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.
|- Exclusion criteria||-Airflow limitiation in baseline spirometry (forced expiratory volume in the first second (FEV1), <60% of predicted). |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jun-2015|
|- planned closingdate||1-jan-2016|
|- Target number of participants||100|
|- Interventions||none, only observations|
|- Primary outcome||Presence/absence of exercise induced bronchoconstriction|
|- Secondary outcome||Pediatric asthma control test |
VAS dyspnea score
|- Timepoints||- moment that children undergo an exercise challenge test (part of regular care)|
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Marije Kamphuis|
|- CONTACT for SCIENTIFIC QUERIES|| Marije Kamphuis|
|- Sponsor/Initiator ||University of Twente, Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|University of Twente, Medisch Spectrum Twente|
|- Brief summary||In children, the diagnosis asthma is based mostly on comprehensive anamnesis and physical examination1. Since symptoms of asthma occur episodically, they are often absent during an elective visit to the specialist. A common, highly specific stimulus for asthma in children is exercise, so called exercise-induced bronchial obstruction4,5. However, exercise tests are labor intensive and require specialized facilities, and is therefore used restrictedly in clinical practice1. So, there is a clinical need for a low-cost, objective alternative for the assessment of dyspnea in children, not only to improve asthma diagnostics, but also to enhance self-management of this chronic disease, which is currently a time-consuming process, including regular and costly visits to the specialist3.
This study was designed in order to improve the diagnostic process and monitoring of asthma in children in order to tailor therapy, reduce cost and increase efficiency. We hypothesize that evaluation of asthma symptoms in a home setting serves as the best indicator of the presence, severity and/or control of asthma in children. We consider video-evaluation of asthma symptoms a potential low-end and objective addition to the clinical practice of asthma (including self-management).
The aim of this study is to develop a video-analysis tool that is able to quantify specific asthma symptoms. By taking video recordings of children undergoing exercise-challenge testing, the relationship between pulmonary function and video-analysis of asthma symptoms can be explored in an experimental setting.
|- Main changes (audit trail)|
|- RECORD||3-jun-2015 - 17-okt-2015|