Obstructive Sleep Apnea Syndrome (OSA) and Getemed (GETEMED)

Civil Hospices of Lyon

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: home polysomnography (GETEMED); Device: standard polysomnography (BRAINNET II)

Study type: Interventional

Funder types: Other

Identifiers

NCT01720823

2009.589

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

home polysomnography and standard polysomnography

Experimental group

Description:

home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night.

Treatment:

Device: standard polysomnography (BRAINNET II)

Device: home polysomnography (GETEMED)