<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/NCT03292523</url>
  </required_header>
  <id_info>
    <org_study_id>2016_68</org_study_id>
    <secondary_id>2017-A01542-51</secondary_id>
    <nct_id>NCT03292523</nct_id>
  </id_info>
  <brief_title>Work Productivity in Hyperventilation Syndrome</brief_title>
  <acronym>WHY</acronym>
  <official_title>Work Productivity in Hyperventilation Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Hyperventilation syndrome is associated with impaired quality of life. The aim of the study&#xD;
      is to assess the relationship between work productivity, including absenteeism and&#xD;
      presenteeism, and the severity of hyperventilation syndrome&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2018</start_date>
  <completion_date type="Actual">February 23, 2021</completion_date>
  <primary_completion_date type="Actual">February 23, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Association between the WPAI score and the Nijmegen score</measure>
    <time_frame>At the time of diagnosis (Baseline)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between the WPAI score and dyspnea scales</measure>
    <time_frame>At the time of diagnosis (Baseline)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the WPAI score and quality of life scores</measure>
    <time_frame>At the time of diagnosis (Baseline)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the WPAI score and PaCO2</measure>
    <time_frame>At the time of diagnosis (Baseline)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the WPAI score and the Cognitive Failure Questionnaire score</measure>
    <time_frame>At the time of diagnosis (Baseline)</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Hyperventilation Syndrome</condition>
  <arm_group>
    <arm_group_label>Hyperventilation syndrome</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>Work Productivity and Activity Impairment (WPAI) Multidimensional Dyspnea Profile (MDP) Baseline Dyspnea Index (BDI), MOS-SF36, Hospital Anxiety Depression (HAD) Cognitive Failure Questionnaire (CFQ).</description>
    <arm_group_label>Hyperventilation syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with confirmed hyperventilation syndrome, virgin of any treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Holders of employment contracts for at least 8 days&#xD;
&#xD;
          -  Diagnosis of hyperventilation syndrome confirmed by:&#xD;
&#xD;
        Compatible symptoms and at least two symptoms reproduced by the hyperventilation challenge&#xD;
        test: Nijmegen's score&gt; 23 ; Demonstration of alveolar hyperventilation ( Either on rest&#xD;
        blood and / or at rest (PaCO2 at rest &lt;36 mmHg and D (A-a) O2 normal; Either during the HV&#xD;
        test (increased recovery time of the basic PETCO2 after voluntary hyperventilation (greater&#xD;
        than 5 minutes)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existence of another chronic pulmonary disease (asthma, bronchial dilation, COPD,&#xD;
             diffuse interstitial pneumonia, neuromuscular pathology ...) or cardiac (rhythm&#xD;
             disorder, ischemic heart disease ...) which can participate in dyspnea&#xD;
&#xD;
          -  Psychiatric illness / psychotropic treatment&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patient already included in a clinical research protocol involving new therapeutics&#xD;
             may not be included in this protocol&#xD;
&#xD;
          -  Specific physiotherapy or previous training&#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>Cécile Chenivesse, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Calmette,CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyperventilation syndrome</keyword>
  <keyword>Work productivity</keyword>
  <keyword>Absenteeism</keyword>
  <keyword>Presenteeism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperventilation</mesh_term>
    <mesh_term>Syndrome</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/NCT03292523
org study id: 2016_68
secondary id: 2017-A01542-51
nct id: NCT03292523
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hyperventilation syndrome is associated with impaired quality of life. The aim of the study
      is to assess the relationship between work productivity, including absenteeism and
      presenteeism, and the severity of hyperventilation syndrome
observational model: Cohort
time perspective: Prospective
measure: Association between the WPAI score and the Nijmegen score
time frame: At the time of diagnosis (Baseline)
measure: Association between the WPAI score and dyspnea scales
time frame: At the time of diagnosis (Baseline)
measure: Association between the WPAI score and quality of life scores
time frame: At the time of diagnosis (Baseline)
measure: Association between the WPAI score and PaCO2
time frame: At the time of diagnosis (Baseline)
measure: Association between the WPAI score and the Cognitive Failure Questionnaire score
time frame: At the time of diagnosis (Baseline)
arm group label: Hyperventilation syndrome
intervention type: Other
intervention name: questionnaire
description: Work Productivity and Activity Impairment (WPAI) Multidimensional Dyspnea Profile (MDP) Baseline Dyspnea Index (BDI), MOS-SF36, Hospital Anxiety Depression (HAD) Cognitive Failure Questionnaire (CFQ).
arm group label: Hyperventilation syndrome
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cécile Chenivesse, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Hyperventilation
mesh term: Syndrome