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Obstructive Sleep Apnea Syndrome (OSA) and Getemed (GETEMED)

Primary Purpose

Sleep Apnea, Obstructive

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

home polysomnography (GETEMED)

standard polysomnography (BRAINNET II)

About this trial

This is an interventional diagnostic trial for Sleep Apnea, Obstructive focused on measuring Obstructive Sleep Apnea syndrome, polysomnography, Home monitoring

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Hospices Civils de Lyon- Hôpital Femme Mère Enfant

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

home polysomnography and standard polysomnography

Arm Description

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01720823

First Posted

October 31, 2012

Last Updated

April 4, 2016

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT01720823

Brief Title

Obstructive Sleep Apnea Syndrome (OSA) and Getemed

Acronym

GETEMED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea syndrome, polysomnography, Home monitoring

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

home polysomnography and standard polysomnography

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

home polysomnography (GETEMED)

Other Intervention Name(s)

GETEMED

Intervention Type

Device

Intervention Name(s)

standard polysomnography (BRAINNET II)

Other Intervention Name(s)

BRAINNET II

Primary Outcome Measure Information:

Title

Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children.

Description

Time Frame

1 night

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia FRANCO, MD

Organizational Affiliation

Hospices Civils de Lyon- Hôpital Femme Mère Enfant

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospices Civils de Lyon- Hôpital Femme Mère Enfant

City

Bron

ZIP/Postal Code

69677

Country

France

12. IPD Sharing Statement

Learn more about this trial

Obstructive Sleep Apnea Syndrome (OSA) and Getemed

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