<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/NCT01679782</url>
  </required_header>
  <id_info>
    <org_study_id>FVIE_FA1</org_study_id>
    <nct_id>NCT01679782</nct_id>
  </id_info>
  <brief_title>Involvement of Nervous System in Muscle Weakness in COPD Patients</brief_title>
  <acronym>DesCoM-1</acronym>
  <official_title>Phase 1 Impact of Nocturnal Desaturations on Central Motor Drive in COPD Patients: A New Insight on the Systemic Effects of the Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>5 Santé</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M2H laboratory, Montpellier University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ANRT, National French Agency for Technological Researches</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>5 Santé</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether nervous system alterations and motor drive&#xD;
      failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we&#xD;
      will look after the role of nocturnal hypoxia in these alterations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COPD is a common disease that induces many systemic repercussions. Among these, peripheral&#xD;
      muscle dysfunction is particularly deleterious because it leads to the decreases of the level&#xD;
      of activity and the quality of life for patients. Movement involves activation of many&#xD;
      structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle.&#xD;
      Netherless, the studies which have described peripheral muscle dysfunction have been focused&#xD;
      on the muscle, so they have proposed a reducing vision of the phenomenon. Other studies have&#xD;
      reported cerebral alterations in COPD, like cognitive disturbance, increase of the neuronal&#xD;
      conduction time, and decrease of the white matter density, and were associated with chronic&#xD;
      hypoxemia. Such alterations are consistent with the existence of a decrease of the central&#xD;
      motor drive during voluntary movement in COPD patients. Therefore the study will aim to&#xD;
      determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of voluntary activation</measure>
    <time_frame>2h</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">137</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>COPD nocturnal desaturator</arm_group_label>
    <description>COPD patients who spend 30% of the nigth with a SaO2 &lt; 90%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD no nocturnal desaturator</arm_group_label>
    <description>COPD patients who spend less than 30% of the night with a SaO2 &lt; 90%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>healthy sedentary subjects</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Two groups of COPD patients and one group with healthy sedentary subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD Patients at stage 2 and 3&#xD;
&#xD;
          -  Healthy sedentary subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epilepsy, pace-maker, nervous disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alain AV Varray, Pr</last_name>
    <role>Study Director</role>
    <affiliation>M2H laboratory, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique du Souffle La Vallonie</name>
      <address>
        <city>Lodève</city>
        <zip>34700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>March 9, 2015</last_update_submitted>
  <last_update_submitted_qc>March 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD, nervous system, peripheral muscle dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic 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/NCT01679782
org study id: FVIE_FA1
nct id: NCT01679782
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether nervous system alterations and motor drive
      failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we
      will look after the role of nocturnal hypoxia in these alterations.
COPD is a common disease that induces many systemic repercussions. Among these, peripheral
      muscle dysfunction is particularly deleterious because it leads to the decreases of the level
      of activity and the quality of life for patients. Movement involves activation of many
      structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle.
      Netherless, the studies which have described peripheral muscle dysfunction have been focused
      on the muscle, so they have proposed a reducing vision of the phenomenon. Other studies have
      reported cerebral alterations in COPD, like cognitive disturbance, increase of the neuronal
      conduction time, and decrease of the white matter density, and were associated with chronic
      hypoxemia. Such alterations are consistent with the existence of a decrease of the central
      motor drive during voluntary movement in COPD patients. Therefore the study will aim to
      determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Level of voluntary activation
time frame: 2h
arm group label: COPD nocturnal desaturator
description: COPD patients who spend 30% of the nigth with a SaO2 < 90%.
arm group label: COPD no nocturnal desaturator
description: COPD patients who spend less than 30% of the night with a SaO2 < 90%
arm group label: control group
description: healthy sedentary subjects
whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alain AV Varray, Pr
role: Study Director
affiliation: M2H laboratory, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive