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NCT05547477 Clinical Trial

Continuous EMG Measurements in Children With Asthma During Sleep

Asthma in Children Clinical Trial

Official title:
Continuous EMG Measurements in Children With Asthma During Sleep

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05547477
Other study ID # R22.068
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2022
Est. completion date January 2023

Study information
Verified date September 2022
Source Medisch Spectrum Twente
Contact Ruben Smink
Phone +31 53 487 2310
Email R.K.Smink@mst.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to investigate whether electromyography of the diaphragm during sleep in asthmatic children can be used to objectively monitor asthma control.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date January 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medisch Spectrum Twente

Outcome
Type Measure Description Time frame Safety issue
Primary Breathing registration in sleep using electromyography Amplitude of the EMG signal will be used to obtain breathing waveforms. From admittance to the ward, up to 12 hours
Secondary Prediction of asthma exacerbations A machine learning model will be applied to be able to predict an asthma exacerbation before it occurs After inclusion of all subjects, up to 3 months
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