Obstructive Sleep Apnea Syndrome (OSA) and Getemed

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: home polysomnography (GETEMED)
* Device: standard polysomnography (BRAINNET II)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: home polysomnography and standard polysomnography<br>home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night. | Device: home polysomnography (GETEMED)<br> <br> * Other names: GETEMED;Device: standard polysomnography (BRAINNET II)<br> <br> * Other names: BRAINNET II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children. | 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 : Respiratory Disturbance Index (RDI) > 10 / hr + /- Desaturation Index > 4% for more than 2.5 / hr. Brouillette index ; pulse wave > 3 desaturation clusters and > 3 desaturation <90%. | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography. |  | 1 night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea syndrome, polysomnography, Home monitoring