The objective is to find the most effective combination of wearable devices to accurately reflect paediatric asthma control in a home monitoring situation, by studying the relation of the home-measured signals to the currently used exercise…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter of this study is *asthma control*. A multiple logistic
regression will be used to determine which home-monitoring parameters are the
most relevant for assessing asthma control in children.
Secondary outcome
Secundary outcomes of this study include: the accuracy and reproducability of
the wearables; The clinical feasability of the wearables; The difference of the
home-measured parameters between healthy subjects and well controlled asthma
patients; The patient perception of their asthma control; The agreement of the
Enose measurements with the exercise challenge tests outcome of asthma control;
Background summary
Asthma is a chronic disease with a high prevalence and high health care costs.
Pediatric asthma management is focused on control of asthma symptoms, enabling
patients to fully participate in daily life. However, monitoring pediatric
asthma is challenging as symptoms are episodic. and therefore often absent
during clinical visitation. Additionally, childrens expression of asthma
symptoms is often difficult to assess and interpretate.
Home monitoring of asthma symptoms could be used to provide the physician with
more insight into the current asthma status and provide an opportunity to
anticipate into the episodical waves of asthma. Therefore this research will
focus on home monitoring of asthmatic children with the use of wearable
technology.
Study objective
The objective is to find the most effective combination of wearable devices to
accurately reflect paediatric asthma control in a home monitoring situation, by
studying the relation of the home-measured signals to the currently used
exercise challenge tests for assessment of asthma control in children. It is
hypothesized that combining wearable home-monitoring devices can provide a
reliable tool for assessing asthma control.
Study design
This study is described as an observational pilot study. The study consists of
a home-monitoring period of two weeks, which will end with an already planned
exercise challenge test (ECT). The study is further divided in two phases; the
first one for monitoring the asthma subjects and the second one for healthy
subjects.
Study burden and risks
This research does not have any safety risks or benefits for the subjects. This
study is designed on a way to maximize diagnostic value and minimize the burden
to the child. Wearables were chosen based on their pediatric feasibility, size
and minimal invasive character; so that subjects will experience minimal burden
during the two weeks of home monitoring.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59878.044.16 |
| OMON | NL-OMON23181 |