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

This study has been completed.
Information provided by (Responsible Party):
Hospices Civils de Lyon Identifier:
First received: October 31, 2012
Last updated: April 4, 2016
Last verified: April 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 Intervention
Sleep Apnea, Obstructive
Device: home polysomnography (GETEMED)
Device: standard polysomnography (BRAINNET II)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 :

      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%.

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. [ Time Frame: 1 night ]

Enrollment: 62
Study Start Date: October 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: GETEMED
Device: standard polysomnography (BRAINNET II)


Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01720823

Hospices Civils de Lyon- Hôpital Femme Mère Enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Patricia FRANCO, MD Hospices Civils de Lyon- Hôpital Femme Mère Enfant
  More Information

Responsible Party: Hospices Civils de Lyon Identifier: NCT01720823     History of Changes
Other Study ID Numbers: 2009.589
Study First Received: October 31, 2012
Last Updated: April 4, 2016

Keywords provided by Hospices Civils de Lyon:
Obstructive Sleep Apnea syndrome
Home monitoring

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on May 25, 2017