Obstructive Sleep Apnea Syndrome (OSA) and Getemed

NCT01720823 | Completed

• 1 other identifier: 2009.589
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea syndrome; polysomnography; Home monitoring

Outcome Measures

Primary Outcomes (1)

• 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 : 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%.

  1 night

Secondary Outcomes (1)

• To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography.

  1 night

Study Arms (1)

home polysomnography and standard polysomnography

EXPERIMENTAL

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

Device: home polysomnography (GETEMED); Device: standard polysomnography (BRAINNET II)

Interventions

home polysomnography (GETEMED) DEVICE

Also known as: GETEMED

home polysomnography and standard polysomnography

standard polysomnography (BRAINNET II) DEVICE

Also known as: BRAINNET II

home polysomnography and standard polysomnography

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Parents opposed to the study.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon- Hôpital Femme Mère Enfant

Bron, 69677, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Patricia FRANCO, MD

  Hospices Civils de Lyon- Hôpital Femme Mère Enfant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 2, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

FR (1)