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Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events

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ClinicalTrials.gov Identifier: NCT03817762
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement. The automatic analysis of respiratory events has never been evaluated in a pediatric population. The primary objective of this study was to determine the feasibility of pediatric RP in an ENT department routine practice. The second objective was to evaluate the reliability of the automatic signal analysis in children.

Condition or disease
Obstructive Sleep Apnea Hypopnea Syndrome

Detailed Description:
Retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3 years) who benefited from an overnight RP in an ENT hospitalization department between January and August 2016 for OSAS suspicion. Manual detection of respiratory events was performed by the same ENT specialist, and compared to the automatic analysis.
Study Design
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Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Respiratory Polygraphy in Children : Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : August 1, 2016
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Overall signal quality of the respiratory polygraph [ Time Frame: 1 day ]
    retrospective data collection : Overall signal quality of RP (Respiratory polygraphy)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with clinical obstructive sleep apnea hypopnea syndrome in University Health Center
Criteria

Inclusion criteria:

  • Age between 2 and 12 years
  • child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea apnea syndrome

Exclusion criteria:

- over 12 years old

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817762


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Mohamed AKKARI, MD University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03817762    
Other Study ID Numbers: RECHMPL17_0450
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
pediatric obstructive sleep apnea hypopnea syndrome
pediatric respiratory polygraphy
device acceptance
signal quality
automatic detection of respiratory events
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases