<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/NCT03817762</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL17_0450</org_study_id>
    <nct_id>NCT03817762</nct_id>
  </id_info>
  <brief_title>Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events</brief_title>
  <official_title>Respiratory Polygraphy in Children : Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep&#xD;
      apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement.&#xD;
      The automatic analysis of respiratory events has never been evaluated in a pediatric&#xD;
      population. The primary objective of this study was to determine the feasibility of pediatric&#xD;
      RP in an ENT department routine practice. The second objective was to evaluate the&#xD;
      reliability of the automatic signal analysis in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3&#xD;
      years) who benefited from an overnight RP in an ENT hospitalization department between&#xD;
      January and August 2016 for OSAS suspicion. Manual detection of respiratory events was&#xD;
      performed by the same ENT specialist, and compared to the automatic analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall signal quality of the respiratory polygraph</measure>
    <time_frame>1 day</time_frame>
    <description>retrospective data collection : Overall signal quality of RP (Respiratory polygraphy)</description>
  </primary_outcome>
  <enrollment type="Actual">54</enrollment>
  <condition>Obstructive Sleep Apnea Hypopnea Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children with clinical obstructive sleep apnea hypopnea syndrome in University Health&#xD;
        Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age between 2 and 12 years&#xD;
&#xD;
          -  child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea&#xD;
             apnea syndrome&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - over 12 years old&#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>Mohamed AKKARI, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 4, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric obstructive sleep apnea hypopnea syndrome</keyword>
  <keyword>pediatric respiratory polygraphy</keyword>
  <keyword>device acceptance</keyword>
  <keyword>signal quality</keyword>
  <keyword>automatic detection of respiratory events</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03817762
org study id: RECHMPL17_0450
nct id: NCT03817762
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep
      apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement.
      The automatic analysis of respiratory events has never been evaluated in a pediatric
      population. The primary objective of this study was to determine the feasibility of pediatric
      RP in an ENT department routine practice. The second objective was to evaluate the
      reliability of the automatic signal analysis in children.
Retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3
      years) who benefited from an overnight RP in an ENT hospitalization department between
      January and August 2016 for OSAS suspicion. Manual detection of respiratory events was
      performed by the same ENT specialist, and compared to the automatic analysis.
observational model: Other
time perspective: Retrospective
measure: Overall signal quality of the respiratory polygraph
time frame: 1 day
description: retrospective data collection : Overall signal quality of RP (Respiratory polygraphy)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Mohamed AKKARI, MD
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive