<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/NCT04440618</url>
  </required_header>
  <id_info>
    <org_study_id>COROSAS</org_study_id>
    <nct_id>NCT04440618</nct_id>
  </id_info>
  <brief_title>Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy</brief_title>
  <acronym>COROSAS</acronym>
  <official_title>Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</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 study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome&#xD;
      after treatment by combined chemoradiotherapy in a locally advanced stages treated population&#xD;
      of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of&#xD;
      oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on&#xD;
      the subject suggest an increased risk of development of OSAHS for these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of patients with obstructive sleep apnea hypopnea syndrome after treatment combined chemoradiotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of OSAHS as a function of the post-therapeutic delay.</measure>
    <time_frame>Day 28</time_frame>
    <description>Value of the AHI as a function of the post-therapeutic delay which corresponds to the delay compared to the end of the curative treatment carried out for squamous cell carcinoma of the oropharynx. It is obtained after the inclusion visit and the realization of the polygraphy with the IAH score. OSAHS is mild (if IAH ≥ 5 / h and &lt;15 / h), moderate (if IAH ≥ 15 / h and ≤ 30 / h) or severe (if IAH&gt; 30 / h)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Obstructive Sleep Apnea-hypopnea</condition>
  <condition>Oropharyngeal Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Disease-free patients treated for locally advanced oropharyngeal cancer for over 6 months&#xD;
        by radio-chemotherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 18 years old&#xD;
&#xD;
          -  Performance Status 0-2&#xD;
&#xD;
          -  Squamous cell carcinoma of the oropharynx treated with concomitant chemoradiotherapy&#xD;
&#xD;
          -  Treatment termination time greater than 6 months at inclusion&#xD;
&#xD;
          -  Tumor classification (American Joint Committee on Cancer 8th) T2-T4 N0-N3&#xD;
&#xD;
          -  Patient in complete remission at inclusion&#xD;
&#xD;
          -  patient's consent's obtained after information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment for upper aerodigestive tract cancer&#xD;
&#xD;
          -  Incomplete radiotherapyTreatment&#xD;
&#xD;
          -  Neurological pathology wich may affect the functions of the upper aerodigestive tract&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Unweaned alcoholism&#xD;
&#xD;
          -  Tracheotomized patient at the time of the study&#xD;
&#xD;
          -  Patient under protection: subjects with guardianship or under law protection&#xD;
&#xD;
          -  No health insurance coverage&#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_contact>
    <last_name>Xavier DUFOUR, Pr</last_name>
    <phone>05 49 44 33 89</phone>
    <phone_ext>33</phone_ext>
    <email>xavier.dufour@chu-poitiers.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eleonore CHARY, Dr</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eleonore CHARY, Dr</last_name>
      <phone>05 49 44 33 89</phone>
      <phone_ext>33</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>combined chemoradiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <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/NCT04440618
org study id: COROSAS
nct id: NCT04440618
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome
      after treatment by combined chemoradiotherapy in a locally advanced stages treated population
      of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of
      oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on
      the subject suggest an increased risk of development of OSAHS for these patients.
observational model: Other
time perspective: Prospective
measure: Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
time frame: Day 28
description: Number of patients with obstructive sleep apnea hypopnea syndrome after treatment combined chemoradiotherapy.
measure: Severity of OSAHS as a function of the post-therapeutic delay.
time frame: Day 28
description: Value of the AHI as a function of the post-therapeutic delay which corresponds to the delay compared to the end of the curative treatment carried out for squamous cell carcinoma of the oropharynx. It is obtained after the inclusion visit and the realization of the polygraphy with the IAH score. OSAHS is mild (if IAH ≥ 5 / h and <15 / h), moderate (if IAH ≥ 15 / h and ≤ 30 / h) or severe (if IAH> 30 / h)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xavier DUFOUR, Pr
phone: 05 49 44 33 89
phone ext: 33
email: xavier.dufour@chu-poitiers.fr
last name: Eleonore CHARY, Dr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma, Squamous Cell
mesh term: Oropharyngeal Neoplasms
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive