Asthma in ChildrenNCT05547477
Continuous EMG Measurements in Children With Asthma During Sleep
An observational study of Asthma in Children and Electromyography, run by Medisch Spectrum Twente.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Asthma in Children, Electromyography, Sleep-Disordered Breathing
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Paediatrician diagnosed asthma or bronchial hyperresponsiveness
- Aged 4 till 18
- Admitted to the paediatric ward of Medisch Spectrum Twente
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Medical subject headings
- Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing registration in sleep using electromyography
Amplitude of the EMG signal will be used to obtain breathing waveforms.
Measured: From admittance to the ward, up to 12 hours
Secondary outcomes (1)
Prediction of asthma exacerbations
A machine learning model will be applied to be able to predict an asthma exacerbation before it occurs
Measured: After inclusion of all subjects, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Job van der Palen, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547477
- Sponsor's protocol ID
- R22.068
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous EMG Measurements in Children With Asthma During Sleep
- ClinicalTrials.gov ID
- NCT05547477
- Acronym / sponsor ID
- R22.068
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Paediatrician diagnosed asthma or bronchial hyperresponsiveness
- Aged 4 till 18
- Admitted to the paediatric ward of Medisch Spectrum Twente
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breathing registration in sleep using electromyography
Time frame: From admittance to the ward, up to 12 hours
Amplitude of the EMG signal will be used to obtain breathing waveforms.
1 secondary outcome
Prediction of asthma exacerbations
Time frame: After inclusion of all subjects, up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Electromyography, run by Medisch Spectrum Twente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruben Smink (+31 53 487 2310, R.K.Smink@mst.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing registration in sleep using electromyography (time frame: From admittance to the ward, up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.