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OpenTrials
Completed

NCT Number: NCT01720823

Obstructive Sleep Apnea Syndrome (OSA) and Getemed

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.

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Key information

Conditions

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

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon- Hôpital Femme Mère Enfant

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

home polysomnography (GETEMED)

Device

Other names: GETEMED

standard polysomnography (BRAINNET II)

Device

Other names: BRAINNET II

Primary outcomes

  1. 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%.

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.

    Time frame: 1 night

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: GETEMED

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 2, 2012
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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