Obstructive Sleep Apnea Syndrome (OSA) and Getemed

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01720823

Acronym

GETEMED

Enrollment

Registered

2012-11-02

Start date

2012-10-31

Completion date

2016-01-31

Last updated

2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea syndrome, polysomnography, Home monitoring

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.

Interventions

DEVICEhome polysomnography (GETEMED)

DEVICEstandard polysomnography (BRAINNET II)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026