<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/NCT04423952</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200195</org_study_id>
    <secondary_id>2019-A00377-50</secondary_id>
    <nct_id>NCT04423952</nct_id>
  </id_info>
  <brief_title>Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR</brief_title>
  <acronym>COMQ12-FR</acronym>
  <official_title>Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 World Health Organization estimates that chronic otitis media could reach between 65 and&#xD;
      350 million people worldwide and thus be an important cause of medical consultation and&#xD;
      prescription drugs.&#xD;
&#xD;
      The medical care of chronic otitis is difficult, despite several medical and surgical&#xD;
      treatment options. Moreover this pathology is gladly recurrent.&#xD;
&#xD;
      The completion of a standardized questionnaire to track symptoms objectively over time is&#xD;
      fundamental to verify the efficacy of specific treatments and to compare treatments.&#xD;
&#xD;
      The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a&#xD;
      new questionnaire, validated in English, to assist the physician in evaluating chronic otitis&#xD;
      media.&#xD;
&#xD;
      The objective of this study is to translate and validate the test in French in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The World Health Organization estimates that chronic otitis media could reach between 65 and&#xD;
      350 million people worldwide and thus be an important cause of medical consultation and&#xD;
      prescription drugs.&#xD;
&#xD;
      The medical care of chronic otitis is difficult, despite several medical and surgical&#xD;
      treatment options. Moreover this pathology is often recurrent.&#xD;
&#xD;
      The completion of a standardized questionnaire to track symptoms objectively over time is&#xD;
      fundamental to verify the efficacy of specific treatments and to compare treatments.&#xD;
&#xD;
      The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a&#xD;
      new questionnaire, validated in English, to assist the physician in evaluating chronic otitis&#xD;
      media.&#xD;
&#xD;
      The original version of the COMQ12 questionnaire, in English, was developed by Phillips et&#xD;
      al.. The construction of this questionnaire was based on three other questionnaires : the&#xD;
      Chronic Ear Survey (CES), the Chronic Otitis Media Outcome-15 (COMOT-15), and the Chronic&#xD;
      Otitis Media-5 (COM-5). The initial validation of the English version of Phillips et al. was&#xD;
      evaluated with an alpha value of Cronbach to 0.889, which shows high internal consistency and&#xD;
      would allow its use in several reputed international centers of otology.&#xD;
&#xD;
      The objective of this study is to translate and validate the test in French in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study never started&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2021</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reproducibility</measure>
    <time_frame>1 year</time_frame>
    <description>Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consistency reliability test</measure>
    <time_frame>1 year</time_frame>
    <description>Measure of efficiency. Comparison of questionnaires completed by patients and controls.&#xD;
COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Item-total Pearson correlation</measure>
    <time_frame>1 year</time_frame>
    <description>Measure of efficiency. Comparison of questionnaires completed by patients and controls.&#xD;
COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Principal components analysis</measure>
    <time_frame>1 year</time_frame>
    <description>Measure of efficiency. Comparison of questionnaires completed by patients and controls.&#xD;
COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Otitis Media</condition>
  <arm_group>
    <arm_group_label>Patients with chronic otitis media</arm_group_label>
    <description>Patients aged 7 to 15 years with chronic otitis media.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Minors aged 7 to 15 years, with no and no history of chronic otitis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COMQ-12 questionnaire</intervention_name>
    <description>Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Patients with chronic otitis media</arm_group_label>
    <other_name>Patient questionnaire</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients followed by the department of otolaryngology and cervico-facial surgery of&#xD;
        Necker-Enfants Malades hospital and siblings for the control subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minors aged 7 to 15 years (inclusive)&#xD;
&#xD;
          -  Patients with chronic otitis media, united or bilateral&#xD;
&#xD;
          -  Controls: subjects without chronic otitis media or any other pathology of the ear at&#xD;
             the time of Inclusion or in background&#xD;
&#xD;
          -  holders of parental authority not opposed to participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Non-comprehension of french&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Françoise Denoyelle, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Necker-Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic otitis media in children</keyword>
  <keyword>Standardized quality of life measurement questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Otitis</mesh_term>
    <mesh_term>Otitis Media</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/NCT04423952
org study id: APHP200195
secondary id: 2019-A00377-50
nct id: NCT04423952
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The World Health Organization estimates that chronic otitis media could reach between 65 and
      350 million people worldwide and thus be an important cause of medical consultation and
      prescription drugs.

      The medical care of chronic otitis is difficult, despite several medical and surgical
      treatment options. Moreover this pathology is gladly recurrent.

      The completion of a standardized questionnaire to track symptoms objectively over time is
      fundamental to verify the efficacy of specific treatments and to compare treatments.

      The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a
      new questionnaire, validated in English, to assist the physician in evaluating chronic otitis
      media.

      The objective of this study is to translate and validate the test in French in children.
The World Health Organization estimates that chronic otitis media could reach between 65 and
      350 million people worldwide and thus be an important cause of medical consultation and
      prescription drugs.

      The medical care of chronic otitis is difficult, despite several medical and surgical
      treatment options. Moreover this pathology is often recurrent.

      The completion of a standardized questionnaire to track symptoms objectively over time is
      fundamental to verify the efficacy of specific treatments and to compare treatments.

      The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a
      new questionnaire, validated in English, to assist the physician in evaluating chronic otitis
      media.

      The original version of the COMQ12 questionnaire, in English, was developed by Phillips et
      al.. The construction of this questionnaire was based on three other questionnaires : the
      Chronic Ear Survey (CES), the Chronic Otitis Media Outcome-15 (COMOT-15), and the Chronic
      Otitis Media-5 (COM-5). The initial validation of the English version of Phillips et al. was
      evaluated with an alpha value of Cronbach to 0.889, which shows high internal consistency and
      would allow its use in several reputed international centers of otology.

      The objective of this study is to translate and validate the test in French in children.
observational model: Case-Control
time perspective: Prospective
measure: Reproducibility
time frame: 1 year
description: Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
measure: Consistency reliability test
time frame: 1 year
description: Measure of efficiency. Comparison of questionnaires completed by patients and controls.
COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
measure: Item-total Pearson correlation
time frame: 1 year
description: Measure of efficiency. Comparison of questionnaires completed by patients and controls.
COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
measure: Principal components analysis
time frame: 1 year
description: Measure of efficiency. Comparison of questionnaires completed by patients and controls.
COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
arm group label: Patients with chronic otitis media
description: Patients aged 7 to 15 years with chronic otitis media.
arm group label: Controls
description: Minors aged 7 to 15 years, with no and no history of chronic otitis.
intervention type: Other
intervention name: COMQ-12 questionnaire
description: Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.
arm group label: Controls
arm group label: Patients with chronic otitis media
other name: Patient questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 15 Years
healthy volunteers: No
last name: Françoise Denoyelle, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Otitis
mesh term: Otitis Media
sharing ipd: No