NCT05547477

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 9, 2022

Last Update Submit

September 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Prediction of asthma exacerbations

    After inclusion of all subjects, up to 3 months

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The investigators aim to include 20 paediatric patients with paediatrician diagnosed asthma of bronchial hyperresponsiveness, admitted to the paediatric ward of Medisch Spectrum Twente.

You may qualify if:

  • Paediatrician diagnosed asthma or bronchial hyperresponsiveness
  • Aged 4 till 18
  • Admitted to the paediatric ward of Medisch Spectrum Twente

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 21, 2022

Study Start

September 1, 2022

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

September 21, 2022

Record last verified: 2022-09