To investigate the relation between cough sound characteristics and the ECT-determined asthma control.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is to correlate the cough sound parameters to
ECT-determined asthma control reflected by the behaviour of the FEV1 during the
ECT. The following cough sound parameters will be tested for their correlation
to asthma control:
* The amount of coughs executed by the patient, during both day and night.
* The duration of a cough and the duration of its phases, the intensity,
skewness, kurtosis, the dominant frequency, fundamental frequencies for the
duration of the cough, the power, the spectrogram of the cough and the mel
frequency ceptrum.
These parameters will be derived from several measurements:
* From the baseline cough performed prior to the ECT.
* From the cough corresponding to the time instance of the lowest FEV1 of the
ECT.
* From the difference between de baseline cough and the cough of the lowest
FEV1.
* From the voluntary coughs which were measured during the home-monitoring
period.
Secondary outcome
The secondary parameters of this study yield:
* The correlation between the cough sound parameters and asthma control based
on the FOT measurements. FOT based asthma control will be defined as in the
statement of the ATS and ERS.67
* The willingness to take part in this study, reflected by the amount of
accepted invitations to take part in this study and the amount of invitations
send to participate in this study.
* The experience of the patients with wearing the cough measuring device in a
non-conventional way, reflected by a questionnaire about the GENEActiv device.
* The correlation of coughs and it*s parameters measured by the GENEActiv
device and by sound recordings.
* The change in the cough parameters as a function of FEV1, as measured at home.
* The correlation between voluntary and involuntary coughs, measured in a
clinical environment.
* The correlation between in-home measured voluntary and involuntary coughs.
* The correlation of coughs measured by two different accelerometers with
different sample frequencies (100 Hz versus 1000 Hz).
* The correlation between the perceived asthma control, as determined by the
C-ACT and PAQLQ, and the amount of coughs exerted during the day and during the
night.
* The in-patient variances in cough parameters and their accompanying FEV1, due
to sleeping.
* The in-patient variances in cough parameters and their accompanying FEV1, due
to inhalation of a SABA.
Background summary
Asthma is a common disease amongst Dutch children, with an occurrence of 23%.
In order to achieve good asthma control, regular contact with a health care
provider is advised, but however not always feasible. Telehealthcare therefore
might offer a solution. The majority of current telehealthcare systems for
asthma are based upon questionnaires; while children*s* and parents* perception
of asthma control is not always reliable. This research focus on one of the
common symptoms of asthma; coughing, which shows promise as a diagnostic tool
for asthma.
Study objective
To investigate the relation between cough sound characteristics and the
ECT-determined asthma control.
Study design
The study is a observational pilot study and consist of a 1 week
home-monitoring period.
Study burden and risks
This research does not have any safety risks or benefits for the subjects. This
study is designed to maximize the diagnostic value and minimize the burden of
the child. Wearables were chosen based on their paediatric feasibility, size
and minimal invasive character; so that subjects will experience a minimal
burden during the week of home-monitoring.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
- Children with paediatrician diagnosed asthma, or children whom are suspected to suffer from asthma, based on reported symptoms and physical examination performed by a physician.
- Children aged between 4 and 14 years old.
- Children whom will receive an exercise challenge test.
Exclusion criteria
* Children who are unable to speak Dutch, or whose legal guardians are unable to speak Dutch.
* Children for whom it is not possible to wear all wearables.
* Children with implanted electrical stimulating devices.
* Children with a known band-aid allergy.
* Children with psychomotor retardation.
* Children with chronic diseases (other than asthma).
* Children whom were born prematurely (* 37 weeks).
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 | NL65431.044.18 |
| OMON | NL-OMON20576 |