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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01720823
First received: October 31, 2012
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 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)
Other Name: BRAINNET II

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720823

Contacts
Contact: Patricia FRANCO, MD +33 (0)4 27 85 60 52 patricia.franco@chu-lyon.fr
Contact: Ségolène GAILLARD, CPM +33 (0) 72 35 75 51 segolene.gaillard@chu-lyon.fr

Locations
France
Hospices Civils de Lyon- Hôpital Femme Mère Enfant Recruiting
Bron, France, 69677
Contact: Patricia FRANCO, MD    +33 (0)4 27 85 60 52    patricia.franco@chu-lyon.fr   
Contact: Segolene GAILLARD, CPM    +33 (0) 72 35 75 51    segolene.gaillard@chu-lyon.fr   
Principal Investigator: Patricia FRANCO, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Patricia FRANCO, MD Hospices Civils de Lyon- Hôpital Femme Mère Enfant
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01720823     History of Changes
Other Study ID Numbers: 2009.589
Study First Received: October 31, 2012
Last Updated: September 24, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Syndrome
Disease
Dyssomnias
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014