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

Completed

• Conditions: Obstructive Sleep Apnea Hypopnea Syndrome

• Registration Number: NCT03817762
• Lead Sponsor: University Hospital, Montpellier

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.

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-08-01
• Study Completion: 2018-08-01
• Status Verified: 2018-10
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall signal quality of the respiratory polygraph	1 day	retrospective data collection : Overall signal quality of RP (Respiratory polygraphy)

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France