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Completed

NCT Number: NCT03845062

Contribution of Drug Induced Sleep Endoscopy of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome

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.

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Key information

Conditions

Obstructive Sleep Apnea Hypopnea Syndrome

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lack of data

Treatment and study plan

Primary outcomes

  1. sleep endoscopy

    Time frame: 1 day

    describe the modification of therapeutic management induced by sleep endoscopy

Secondary outcomes

  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".

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Contribution of Drug Induced Sleep Endoscopy in the Management of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome

Acronym: ESSI

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2019
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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