To investigate whether electromyography of the diaphragm during sleep in asthmatic children can be used to objectively monitor asthma control.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in muscle activity are compared before and after administration of
bronchodilator drugs. In addition, it will be examined whether the data
obtained from EMG can be compared with the data from the RIP measurements.
Secondary outcome
Not applicable
Background summary
Asthma is one of the most common chronic inflammatory diseases in children. One
of the characteristics of asthma is that patients experience dyspnea during
sleep, if the asthma symptoms are poorly controlled. The combination of
poorly-controlled asthma and sleep disorders could be a cause of the lower
quality of life experienced by children with poorly controlled asthma.
Electromyography (EMG) is used as an experimental tool to measure the activity
of the diaphragm in paediatric patients with asthma. EMG could provide easy,
passive method for monitoring asthma during sleep.
Study objective
To investigate whether electromyography of the diaphragm during sleep in
asthmatic children can be used to objectively monitor asthma control.
Study design
The study will have a cross-sectional design. The measuring equipment is
connected during an admission to the paediatric ward. The measurements will
take place overnight.
Study burden and risks
The study poses no risks to test subjects. The measurements are taken in
addition to regular care according to current guidelines. During this study,
subjects are asked to wear a close-fitting shirt with 3 electrodes underneath
for 1 night. This examination does not entail any additional burden. The study
should be conducted in children, because the asthma population in children is
more vulnerable and clearly different from the adult population.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
Paediatrician diagnosed asthma or bronchial hyperresponsiveness
Aged 4 till 18
Admitted to the paediatric ward of Medisch Spectrum Twente
Exclusion criteria
Admittance to the ICU
Patient has ICD or pacemaker
Parents and/or patient cannot understand or speak Dutch
Does not fit in one of the available Hexoskin shirts
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05547477 |
| CCMO | NL81950.100.22 |