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Contribution of Drug Induced Sleep Endoscopy of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome (ESSI)

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ClinicalTrials.gov Identifier: NCT03845062
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
The role of drug-induced sleep endoscopy (DISE) in the management of obstructive sleep apnea hypopnea syndrome (OSAHS) is not precisely defined for children. The primary objective of this study was to describe the consequences of DISE in the therapeutic management for children with OSAHS. The secondary objectives were to analyze the correlation between the number of obstructive sites found during DISE, the value of apnea-hypopnea index (AHI), and the type of OSAHS.

Condition or disease
Obstructive Sleep Apnea Hypopnea Syndrome

Detailed Description:
Retrospective single center study of 31 children (mean age: 5.5 ± 2.6 years) who benefited from DISE between 2015 and 2018 in the management of OSAHS. Modification of therapeutic management was noted. A correlation between the number of obstructive sites and the IAH on the one hand, and between the number of obstructive sites and the type of SAHOS on the other hand, was sought.
Study Design
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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Contribution of Drug Induced Sleep Endoscopy in the Management of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : August 1, 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. sleep endoscopy [ Time Frame: 1 day ]
    describe the modification of therapeutic management induced by sleep endoscopy


Secondary Outcome Measures :
  1. Number of obstructive site during [ Time Frame: 1 day ]
    retrospective data collection : Number of obstructive site during

  2. value of apnea-hypopnea index [ Time Frame: 1 day ]
    retrospective data collection : value of apnea-hypopnea index

  3. type obstructive hypopnoea apnea syndrome of sleep [ Time Frame: 1 day ]
    type obstructive hypopnoea apnea syndrome of sleep. Children facing craniofacial or neuromuscular disorders were rated in "Type III OSAHS". Obese children were rated in "Type II OSAHS". Others children were rated by default in "Type I OSAHS".


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

Inclusion criteria:

- OSAHS confirmed by overnight sleep monitoring (respiratory polygraphy or overnight polysomnography)

Exclusion criteria:

- Lack of data

Contacts and Locations
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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): NCT03845062


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: NCT03845062    
Other Study ID Numbers: RECHMPL18_0333
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: September 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:
drug-induced sleep endoscopy
pediatric obstructive sleep apnea hypopnea syndrome
tongue base
epiglottis
 occult laryngomalacia
lingual tonsillectomy
epiglottopexy
aryepiglottic folds division
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases