Obstructive Sleep Apnea Syndrome (OSA) and Getemed

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: home polysomnography (GETEMED); Device: standard polysomnography (BRAINNET II)

• Registration Number: NCT01720823
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital.

Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-02
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Male and female subjects, aged 2 to 6 years old, requiring a polysomnography or admitted for intense snoring or suspected sleep apnea
• Parents must have signed the inform consent form and be covered by the National Health Insurance Program.

Exclusion Criteria

• Parents opposed to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
home polysomnography and standard polysomnography	home polysomnography (GETEMED)	home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night.
home polysomnography and standard polysomnography	standard polysomnography (BRAINNET II)	home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night.

Primary Outcome Measures

Name	Time	Method
Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children.	1 night	* Standard polysomnography considered pathological if obstructive apnea-hypopnea index (AHI) \> 5 / hr.; * Home polysomnography considered pathological if at least one of the following criteria is present : 1. Respiratory Disturbance Index (RDI) \> 10 / hr + /- Desaturation Index \> 4% for more than 2.5 / hr.; 2. Brouillette index ; pulse wave \> 3 desaturation clusters and \> 3 desaturation \<90%.

Secondary Outcome Measures

Name	Time	Method
To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography.	1 night

Trial Locations

Locations (1)

Hospices Civils de Lyon- Hôpital Femme Mère Enfant; 🇫🇷 Bron, France