<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/NCT04418973</url>
  </required_header>
  <id_info>
    <org_study_id>2019_0074</org_study_id>
    <nct_id>NCT04418973</nct_id>
  </id_info>
  <brief_title>Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.</brief_title>
  <acronym>Volatopnee</acronym>
  <official_title>Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject, by a Threshold Inspiratory Load and During a Maximal Breath Holding.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</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 dyspnea is a common symptom in patients with many respiratory diseases particularly&#xD;
      chronic obstructive airway diseases, but also cardiovascular pathologies, obesity, or also in&#xD;
      the deconditioned healthy subjects.&#xD;
&#xD;
      Called volatolom corresponds to the set of volatile organic compounds (VOCs) contained in&#xD;
      exhaled air.&#xD;
&#xD;
      The analysis of volatolom can be done either by the methods based on mass spectrometry which&#xD;
      allows the identification of each VOC in the exhaled air or by the use of electronic noses&#xD;
      which are more simple to use, less specific and produce a quantitive signal change based on&#xD;
      pattern recognition algorithms providing a global profile of the VOC without identifying&#xD;
      them.&#xD;
&#xD;
      The aim of the study is to determine whether the analysis of VOCs in exhaled air would&#xD;
      identify biomarkers related to the intensity and type of experimental dyspnea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2020</start_date>
  <completion_date type="Actual">October 14, 2020</completion_date>
  <primary_completion_date type="Actual">October 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of variation of volatile organic compounds profiles in exhaled air during dyspnea and normal breathing.</measure>
    <time_frame>at the only one study visit: around 2 hours</time_frame>
    <description>Comparison of variation in VOC profiles in exhaled air of healthy subjects, over 2 types of dyspnea (inspiratory load and breath holding) relative to VOC profiles during normal rest ventilation. The VOC will be identified by their molecular mass (by the mass spectrometry) and the variations in the sensors properties of the electronic noses producing a quantitive signal change based on pattern recognition algorithms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea.</measure>
    <time_frame>at the only one study visit: around 2 hours</time_frame>
    <description>Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea (inspiratory load and breath holding).The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the intensity of the affective component of the dyspnea and the variation of VOC profiles.</measure>
    <time_frame>at the only one study visit: around 2 hours</time_frame>
    <description>Correlation between the results of 2 questionnaires (affective multidimensional dyspnea and affective visual analogue scale) and the VOC profiles, in each of the 2 types of dyspnea.The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the intensity of the sensory components of the dyspnea and the variation of VOC profiles.</measure>
    <time_frame>at the only one study visit: around 2 hours</time_frame>
    <description>Correlation between the results of 2 patient sensory questionnaires (sensory multidimensional dyspnea and sensory visual analogue scale) and the VOC profiles of dyspnea.The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of VOC profiles in exhaled air according to smoking status.</measure>
    <time_frame>at the only one study visit: around 2 hours</time_frame>
    <description>Comparison of VOC profiles in exhaled air of healthy subjects, in each of the 2 types of dyspnea smokers or non smokers. The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>A - load/apnea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Threshold inspiratory load then apnea</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B- apnea/load</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>apnea than threshold inspiratory load</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VOCs analysis in exhaled air</intervention_name>
    <description>using an electronic nose and a mass spectrometry</description>
    <arm_group_label>A - load/apnea</arm_group_label>
    <arm_group_label>B- apnea/load</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subject&#xD;
&#xD;
          -  no dyspnea&#xD;
&#xD;
          -  non smoking or daily smoking more than 5 years packs&#xD;
&#xD;
          -  perfect knowing of the French language&#xD;
&#xD;
          -  the consent form signed&#xD;
&#xD;
          -  affiliated to a health insurance plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic disease&#xD;
&#xD;
          -  history of asthma or Chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  personal or family atopy&#xD;
&#xD;
          -  cannabis use&#xD;
&#xD;
          -  electronic cigarette&#xD;
&#xD;
          -  medication except contraception&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  without liberty or guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Devillier</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foch hospital</name>
      <address>
        <city>Suresnes</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>February 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>October 21, 2020</last_update_submitted>
  <last_update_submitted_qc>October 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volatolom</keyword>
  <keyword>Volatile organic compounds (VOCs)</keyword>
  <keyword>dyspnea</keyword>
  <keyword>electronic nose</keyword>
  <keyword>mass spectrometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</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/NCT04418973
org study id: 2019_0074
nct id: NCT04418973
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The dyspnea is a common symptom in patients with many respiratory diseases particularly
      chronic obstructive airway diseases, but also cardiovascular pathologies, obesity, or also in
      the deconditioned healthy subjects.

      Called volatolom corresponds to the set of volatile organic compounds (VOCs) contained in
      exhaled air.

      The analysis of volatolom can be done either by the methods based on mass spectrometry which
      allows the identification of each VOC in the exhaled air or by the use of electronic noses
      which are more simple to use, less specific and produce a quantitive signal change based on
      pattern recognition algorithms providing a global profile of the VOC without identifying
      them.

      The aim of the study is to determine whether the analysis of VOCs in exhaled air would
      identify biomarkers related to the intensity and type of experimental dyspnea.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Comparison of variation of volatile organic compounds profiles in exhaled air during dyspnea and normal breathing.
time frame: at the only one study visit: around 2 hours
description: Comparison of variation in VOC profiles in exhaled air of healthy subjects, over 2 types of dyspnea (inspiratory load and breath holding) relative to VOC profiles during normal rest ventilation. The VOC will be identified by their molecular mass (by the mass spectrometry) and the variations in the sensors properties of the electronic noses producing a quantitive signal change based on pattern recognition algorithms.
measure: Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea.
time frame: at the only one study visit: around 2 hours
description: Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea (inspiratory load and breath holding).The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose).
measure: Correlation between the intensity of the affective component of the dyspnea and the variation of VOC profiles.
time frame: at the only one study visit: around 2 hours
description: Correlation between the results of 2 questionnaires (affective multidimensional dyspnea and affective visual analogue scale) and the VOC profiles, in each of the 2 types of dyspnea.The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose).
measure: Correlation between the intensity of the sensory components of the dyspnea and the variation of VOC profiles.
time frame: at the only one study visit: around 2 hours
description: Correlation between the results of 2 patient sensory questionnaires (sensory multidimensional dyspnea and sensory visual analogue scale) and the VOC profiles of dyspnea.The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose).
measure: Comparison of VOC profiles in exhaled air according to smoking status.
time frame: at the only one study visit: around 2 hours
description: Comparison of VOC profiles in exhaled air of healthy subjects, in each of the 2 types of dyspnea smokers or non smokers. The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose).
arm group label: A - load/apnea
arm group type: Experimental
description: Threshold inspiratory load then apnea
arm group label: B- apnea/load
arm group type: Experimental
description: apnea than threshold inspiratory load
intervention type: Other
intervention name: VOCs analysis in exhaled air
description: using an electronic nose and a mass spectrometry
arm group label: A - load/apnea
arm group label: B- apnea/load
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe Devillier
role: Principal Investigator
affiliation: Hopital Foch
facility: 
country: France
responsible party type: Sponsor
mesh term: Dyspnea
sharing ipd: No