Obstructive Sleep Apnea Syndrome (OSA) and Getemed (GETEMED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01720823|
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : April 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Device: home polysomnography (GETEMED) Device: standard polysomnography (BRAINNET II)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: home polysomnography and standard polysomnography
home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night.
Device: home polysomnography (GETEMED)
Other Name: GETEMEDDevice: standard polysomnography (BRAINNET II)
Other Name: BRAINNET II
- Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children. [ Time Frame: 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 :
- 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%.
- To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography. [ Time Frame: 1 night ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720823
|Hospices Civils de Lyon- Hôpital Femme Mère Enfant|
|Bron, France, 69677|
|Principal Investigator:||Patricia FRANCO, MD||Hospices Civils de Lyon- Hôpital Femme Mère Enfant|