Continuous EMG Measurements in Children With Asthma Durin... | NCT05547477

Studies
Continuous EMG Measurements in Children With Asthma During Sleep

NCT05547477

Sponsor

Medisch Spectrum Twente

Status

Unknown status

Last Update Posted

Sep 21, 2022Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Asthma in Children
Electromyography
Sleep-Disordered Breathing

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2022Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Sep 9, 2022

First Submission Date that Met QC Criteria

Sep 16, 2022

First Posted Date

Sep 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2022

Last Update Posted Date

Sep 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ruben Smink	Contact	+31 53 487 2310		R.K.Smink@mst.nl
Pascal Keijzer	Contact	+31 53 487 2310		P.Keijzer@mst.nl

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided