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

Obstructive Sleep Apnea Hypopnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817762
• Other study ID #: RECHMPL17_0450
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: August 1, 2018

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion criteria:

• Age between 2 and 12 years

• child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea apnea syndrome

Exclusion criteria:

• over 12 years old

Related Conditions & MeSH terms

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

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