<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01720823</url>
  </required_header>
  <id_info>
    <org_study_id>2009.589</org_study_id>
    <nct_id>NCT01720823</nct_id>
  </id_info>
  <brief_title>Obstructive Sleep Apnea Syndrome (OSA) and Getemed</brief_title>
  <acronym>GETEMED</acronym>
  <official_title>Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is often clinically impossible to differentiate children with an isolated snoring from&#xD;
      those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based&#xD;
      polysomnography. This expensive examination is poorly accessible due to appointments delays&#xD;
      at hospital.&#xD;
&#xD;
      Our study is designed to compare the characteristics of a home polysomnography versus&#xD;
      standard polysomnography for the diagnosis of pediatric OSA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children.</measure>
    <time_frame>1 night</time_frame>
    <description>Standard polysomnography considered pathological if obstructive apnea-hypopnea index (AHI) &gt; 5 / hr.&#xD;
Home polysomnography considered pathological if at least one of the following criteria is present :&#xD;
Respiratory Disturbance Index (RDI) &gt; 10 / hr + /- Desaturation Index &gt; 4% for more than 2.5 / hr.&#xD;
Brouillette index ; pulse wave &gt; 3 desaturation clusters and &gt; 3 desaturation &lt;90%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography.</measure>
    <time_frame>1 night</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <arm_group>
    <arm_group_label>home polysomnography and standard polysomnography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>home polysomnography (GETEMED)</intervention_name>
    <arm_group_label>home polysomnography and standard polysomnography</arm_group_label>
    <other_name>GETEMED</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>standard polysomnography (BRAINNET II)</intervention_name>
    <arm_group_label>home polysomnography and standard polysomnography</arm_group_label>
    <other_name>BRAINNET II</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects, aged 2 to 6 years old, requiring a polysomnography or&#xD;
             admitted for intense snoring or suspected sleep apnea&#xD;
&#xD;
          -  Parents must have signed the inform consent form and be covered by the National Health&#xD;
             Insurance Program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents opposed to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia FRANCO, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon- Hôpital Femme Mère Enfant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon- Hôpital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>April 4, 2016</last_update_submitted>
  <last_update_submitted_qc>April 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obstructive Sleep Apnea syndrome</keyword>
  <keyword>polysomnography</keyword>
  <keyword>Home monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01720823
org study id: 2009.589
nct id: NCT01720823
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children.
time frame: 1 night
description: 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%.
measure: 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
arm group label: home polysomnography and standard polysomnography
arm group type: Experimental
description: home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night.
intervention type: Device
intervention name: home polysomnography (GETEMED)
arm group label: home polysomnography and standard polysomnography
other name: GETEMED
intervention type: Device
intervention name: standard polysomnography (BRAINNET II)
arm group label: home polysomnography and standard polysomnography
other name: BRAINNET II
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Patricia FRANCO, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon- Hôpital Femme Mère Enfant
facility: 
country: France
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive