<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/NCT03003429</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0376</org_study_id>
    <secondary_id>2016-A01659-42</secondary_id>
    <nct_id>NCT03003429</nct_id>
  </id_info>
  <brief_title>Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa</brief_title>
  <acronym>VARIASTRESS</acronym>
  <official_title>Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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 heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the&#xD;
      model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the&#xD;
      parasympathetic nervous system and a decrease of the sympathetic system. Various explanations&#xD;
      of this these dysfunctions are proposed in literature, mainly malnutrition, physical&#xD;
      hyperactivity, anxiety, that are known characteristics of anorexia nervosa.&#xD;
&#xD;
      The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety&#xD;
      in anorexia nervosa.&#xD;
&#xD;
      Other objectives of this study are firstly to evaluate correlation between ANS dysfunction&#xD;
      and others parameters (weight, body mass index, depression, physical activity, purgative ou&#xD;
      restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if&#xD;
      HRV is a predictive parameter of the evolution of anorexia nervosa.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">September 12, 2018</completion_date>
  <primary_completion_date type="Actual">September 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Statistical correlation between autonomic dysfunction (measured by HRV) and anxiety (measured by questionnaire)</measure>
    <time_frame>at day 0</time_frame>
    <description>The composite measure consists of the following :- Time and spectral-domain measures of HRV measured by nocturn registration with heart rate monitor and polar RS800CX Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50 (NN50/total number of all NN), SDANN (Standard deviation of the average of NN intervals in all 5-minute segments of a long recording), SDNNIDX (Mean of the standard deviation in all 5-minute segments of a long recording) Frequency domain - VLF Power (very low frequency; &lt;0.04 Hz), LF Power (low frequency; 0.04~0.15 Hz), HF Power (high frequency; 0.15~0.4 Hz), LF/HF ratio value&#xD;
- State-Trait Anxiety Inventory: version Y (STAI- form Y) - Morning blood cortisol level and serum prealbumin lev</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory</measure>
    <time_frame>at day 0</time_frame>
    <description>Beck Depression inventory : Version 2 in french (BDI-II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory</measure>
    <time_frame>at 6 months</time_frame>
    <description>Beck Depression inventory : Version 2 in french (BDI-II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire</measure>
    <time_frame>at 6 months</time_frame>
    <description>International physical activity questionnaire (IPAQ) - French version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire</measure>
    <time_frame>at day 0</time_frame>
    <description>International physical activity questionnaire (IPAQ) - French version</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Heart rate monitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Heart rate monitor</intervention_name>
    <description>The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX</description>
    <arm_group_label>Heart rate monitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Aged from 18 to 65 years&#xD;
&#xD;
          -  Criteria of anorexia nervosa (DSM V)&#xD;
&#xD;
          -  Body mass index (BMI) &lt; 18 kg/m2&#xD;
&#xD;
          -  Written consent to participate in the study&#xD;
&#xD;
          -  Patient affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pacemaker or other implantable electronic device&#xD;
&#xD;
          -  Current comorbidity psychiatric disorder according to Axis I of DSM IV : severe&#xD;
             depression (BDI &gt; 8/13), substance use disorder .&#xD;
&#xD;
          -  Psychotropic drugs or ongoing steroid therapy ;&#xD;
&#xD;
          -  Pregnancy or breast-feeding ;&#xD;
&#xD;
          -  History or known cardiovascular disorder, including hypertension ( &gt; 140/90 mmHg ) ,&#xD;
             heart failure, arrhythmia and conduction disorder .&#xD;
&#xD;
          -  Major protected by a legal protection&#xD;
&#xD;
          -  Minors&#xD;
&#xD;
          -  Patient involved in another research with an exclusion period ongoing at the run-in&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvain ICETA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart rate variability</keyword>
  <keyword>anxiety</keyword>
  <keyword>Autonomic dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Anorexia Nervosa</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/NCT03003429
org study id: 69HCL16_0376
secondary id: 2016-A01659-42
nct id: NCT03003429
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the
      model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the
      parasympathetic nervous system and a decrease of the sympathetic system. Various explanations
      of this these dysfunctions are proposed in literature, mainly malnutrition, physical
      hyperactivity, anxiety, that are known characteristics of anorexia nervosa.

      The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety
      in anorexia nervosa.

      Other objectives of this study are firstly to evaluate correlation between ANS dysfunction
      and others parameters (weight, body mass index, depression, physical activity, purgative ou
      restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if
      HRV is a predictive parameter of the evolution of anorexia nervosa.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Statistical correlation between autonomic dysfunction (measured by HRV) and anxiety (measured by questionnaire)
time frame: at day 0
description: The composite measure consists of the following :- Time and spectral-domain measures of HRV measured by nocturn registration with heart rate monitor and polar RS800CX Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50 (NN50/total number of all NN), SDANN (Standard deviation of the average of NN intervals in all 5-minute segments of a long recording), SDNNIDX (Mean of the standard deviation in all 5-minute segments of a long recording) Frequency domain - VLF Power (very low frequency; <0.04 Hz), LF Power (low frequency; 0.04~0.15 Hz), HF Power (high frequency; 0.15~0.4 Hz), LF/HF ratio value
- State-Trait Anxiety Inventory: version Y (STAI- form Y) - Morning blood cortisol level and serum prealbumin lev
measure: Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
time frame: at day 0
description: Beck Depression inventory : Version 2 in french (BDI-II)
measure: Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
time frame: at 6 months
description: Beck Depression inventory : Version 2 in french (BDI-II)
measure: Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
time frame: at 6 months
description: International physical activity questionnaire (IPAQ) - French version
measure: Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
time frame: at day 0
description: International physical activity questionnaire (IPAQ) - French version
arm group label: Heart rate monitor
arm group type: Experimental
description: The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX
intervention type: Other
intervention name: Heart rate monitor
description: The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX
arm group label: Heart rate monitor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sylvain ICETA, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa