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Continuous EMG Measurements in Children With Asthma During Sleep

Sponsor
Medisch Spectrum Twente (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05547477
Collaborator
(none)
20
Enrollment
4
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Continuous EMG Measurements in Children With Asthma During Sleep
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Breathing registration in sleep using electromyography [From admittance to the ward, up to 12 hours]

      Amplitude of the EMG signal will be used to obtain breathing waveforms.

    Secondary Outcome Measures

    1. Prediction of asthma exacerbations [After inclusion of all subjects, up to 3 months]

      A machine learning model will be applied to be able to predict an asthma exacerbation before it occurs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medisch Spectrum Twente

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Job van der Palen, Research Coordinator, Medisch Spectrum Twente
    ClinicalTrials.gov Identifier:
    NCT05547477
    Other Study ID Numbers:
    • R22.068
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma
    Sleep Apnea Syndromes

    Study Results

    No Results Posted as of Sep 21, 2022