Obstructive Sleep Apnea Syndrome (OSA) and Getemed

NCT ID: NCT01720823

Last Updated: 2016-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-01-31

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.

Detailed Description

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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home polysomnography and standard polysomnography

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

Group Type EXPERIMENTAL

home polysomnography (GETEMED)

Intervention Type DEVICE

standard polysomnography (BRAINNET II)

Intervention Type DEVICE

Interventions

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home polysomnography (GETEMED)

Intervention Type DEVICE

standard polysomnography (BRAINNET II)

Intervention Type DEVICE

Other Intervention Names

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GETEMED BRAINNET II

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia FRANCO, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon- Hôpital Femme Mère Enfant

Locations

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Hospices Civils de Lyon- Hôpital Femme Mère Enfant

Bron, , France

Site Status

Countries

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France

Other Identifiers

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2009.589

Identifier Type: -

Identifier Source: org_study_id

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