<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/NCT04459182</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01855-34</org_study_id>
    <nct_id>NCT04459182</nct_id>
  </id_info>
  <brief_title>Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome</brief_title>
  <acronym>EXODYS</acronym>
  <official_title>Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome(OSA): EXODYS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evaluation of miRNA contained in exosomes in obese and OSA patients with endothelial&#xD;
      dysfunction evaluated by digital plethysmography (ENDOPAT) compared to obese and OSA patients&#xD;
      without endothelial dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to compare the content of exosomes between two goups of 20 patients,&#xD;
      with and without endothelial dysfucntion.&#xD;
&#xD;
      the endothelial function will be evaluated after polysomnography, on obese patients with OSA&#xD;
      (AHI &gt;15).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2021</start_date>
  <completion_date type="Actual">July 6, 2023</completion_date>
  <primary_completion_date type="Actual">July 6, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>miRNA cointained in exosomes</measure>
    <time_frame>immediately after the consultation</time_frame>
    <description>compare exosome content between obese-OSA patients with endothelial dysfunction and without</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <arm_group>
    <arm_group_label>Endothelial dysfunction (DE+)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>obsese patient with OSA (AHI&gt;15) and endothelial dysfunction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No endothelial dysfunction (DE-)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>obsese patient with OSA (AHI&gt;15) and no endothelial dysfunction</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ENDOPAT</intervention_name>
    <description>digital plethysmography</description>
    <arm_group_label>Endothelial dysfunction (DE+)</arm_group_label>
    <arm_group_label>No endothelial dysfunction (DE-)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult subject&#xD;
&#xD;
          -  Subject understands the study protocol and is willing and able to comply with study&#xD;
             requirements and sign informed consent&#xD;
&#xD;
          -  Subject with OSA (defined by AHI &gt;15/h)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac or vascular desease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GAGNADOUX Frédéric, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Angers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Frédéric GAGNADOUX</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04459182
org study id: 2020-A01855-34
nct id: NCT04459182
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of miRNA contained in exosomes in obese and OSA patients with endothelial
      dysfunction evaluated by digital plethysmography (ENDOPAT) compared to obese and OSA patients
      without endothelial dysfunction.
The aim of the study is to compare the content of exosomes between two goups of 20 patients,
      with and without endothelial dysfucntion.

      the endothelial function will be evaluated after polysomnography, on obese patients with OSA
      (AHI >15).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: miRNA cointained in exosomes
time frame: immediately after the consultation
description: compare exosome content between obese-OSA patients with endothelial dysfunction and without
arm group label: Endothelial dysfunction (DE+)
arm group type: Active Comparator
description: obsese patient with OSA (AHI>15) and endothelial dysfunction
arm group label: No endothelial dysfunction (DE-)
arm group type: Sham Comparator
description: obsese patient with OSA (AHI>15) and no endothelial dysfunction
intervention type: Diagnostic Test
intervention name: ENDOPAT
description: digital plethysmography
arm group label: Endothelial dysfunction (DE+)
arm group label: No endothelial dysfunction (DE-)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GAGNADOUX Frédéric, PhD
role: Principal Investigator
affiliation: University Hospital, Angers
facility: 
country: France
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
sharing ipd: No