Wearable technology to assess children*s asthma control in the home-situatio
- Conditions
- bronchial hyper reactivity - asthma10006436
- Registration Number
- NL-OMON47316
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Patients with paediatric based asthma.
Patients aged between 4 and 14 years old.
Patients that receive a clinical exercise challange test.;Or:
Healthy subjects aged between 4 and 14 years old.
Children with an inability to understand or speak Dutch. This also applies for the parents of all children below the age of 12.
Children with a pacemaker / implantable cardioverter-defibrillator (ICD) or other electrical stimulation device.
Children for whom it is not possible to wear all wearables. For example due to severe skin diseases or amputation of the arms etc.
Children with psychomotor retardation
Children with chronic diseases (other than asthma).
Children which use puffer medication which do not fit the Cohoro smart inhaler.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameter of this study is *asthma control*. A multiple logistic<br /><br>regression will be used to determine which home-monitoring parameters are the<br /><br>most relevant for assessing asthma control in children. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary outcomes of this study include: the accuracy and reproducability of<br /><br>the wearables; The clinical feasability of the wearables; The difference of the<br /><br>home-measured parameters between healthy subjects and well controlled asthma<br /><br>patients; The patient perception of their asthma control; The agreement of the<br /><br>Enose measurements with the exercise challenge tests outcome of asthma control; </p><br>