Obstructive Sleep Apnea Syndrome (OSA) and Getemed

Sleep Apnea, Obstructive Clinical Trial

— GETEMED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720823
• Other study ID #: 2009.589
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: April 4, 2016
• Start date: October 2012
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• home polysomnography (GETEMED)

• standard polysomnography (BRAINNET II)

Locations

Country	Name	City	State
France	Hospices Civils de Lyon- Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography.		1 night	No