Clinical Trials Directory

Trials / Completed

CompletedNCT03817762

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
54 (actual)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
2 Years – 12 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2016-01-01
Primary completion
2016-08-01
Completion
2018-08-01
First posted
2019-01-25
Last updated
2019-01-29

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03817762. Inclusion in this directory is not an endorsement.

Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events (NCT03817762) · Clinical Trials Directory