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

Obstructive Sleep Apnea Hypopnea Syndrome Clinical Trial

— ESSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845062
• Other study ID #: RECHMPL18_0333
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: August 1, 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion criteria:

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

Exclusion criteria:

• Lack of data

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Hypopnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep endoscopy	describe the modification of therapeutic management induced by sleep endoscopy	1 day
Secondary	Number of obstructive site during	retrospective data collection : Number of obstructive site during	1 day
Secondary	value of apnea-hypopnea index	retrospective data collection : value of apnea-hypopnea index	1 day
Secondary	type obstructive hypopnoea apnea syndrome of sleep	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".	1 day