<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/NCT04439409</url>
  </required_header>
  <id_info>
    <org_study_id>19CH103</org_study_id>
    <secondary_id>2019-A01343-54</secondary_id>
    <nct_id>NCT04439409</nct_id>
  </id_info>
  <brief_title>Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).</brief_title>
  <acronym>AVASNA</acronym>
  <official_title>AVASNA : Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Cluster Headache (CH) is associated with ipsilateral vegetative signs, related to&#xD;
      parasympathetic system hyperactivity and/or signs of sympathetic hypoactivity. The precise&#xD;
      mechanism of Cluster Headache (CH) is still unknown. The question is whether these&#xD;
      dysautonomic disorders are simply secondary to the Cluster Headache (CH) process or whether&#xD;
      they are the triggering factor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study cares about the evolution of the Autonomic Nervous System (ANS) in Cluster&#xD;
      Headache (CH) seizures. Patients will be offered Holter ECG to study the temporal&#xD;
      relationships between changes in Autonomic Nervous System (ANS) activity during Headache (CH)&#xD;
      seizures and changes in Autonomic Nervous System (ANS) activity before and after seizure&#xD;
      treatment, using heart rate variability measurement.&#xD;
&#xD;
      The hypothesis is that there would be an initial temporary sympathetic activation, followed&#xD;
      quickly by parasympathetic hyperactivation and a return to a state of equilibrium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure</measure>
    <time_frame>Day: 7</time_frame>
    <description>Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure during the basal period, pre-seizure, seizure and after the seizure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure</measure>
    <time_frame>Day: 7</time_frame>
    <description>Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure during the basal period, pre-seizure, seizure and after the seizure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low Frequency during daytime and night seizure</measure>
    <time_frame>Day: 7</time_frame>
    <description>Comparison of measure of Low Frequency during daytime and night seizure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High Frequency (HF) during daytime and night seizure</measure>
    <time_frame>Day: 7</time_frame>
    <description>Comparison of measure of High Frequency (HF) during daytime and night seizure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between several parameters</measure>
    <time_frame>Day: 7</time_frame>
    <description>Correlation between Heart Rate Variability (HRV), changes in the Low Frequency/High Frequency (LF/HF) ratio, the Low Frequency (LF) and the High Frequency (HF), and the intensity of pain measured on the Visual Analog Scale (VAS).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cluster Headache</condition>
  <arm_group>
    <arm_group_label>Patients with Cluster Headache (CH)</arm_group_label>
    <description>Patients with Cluster Headache (CH) will be included. They will have a Holter electrocardiogram during 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Holter electrocardiogram</intervention_name>
    <description>Holter electrocardiogram will be carried during 7 days to measure heart's electrical activity continuously.</description>
    <arm_group_label>Patients with Cluster Headache (CH)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Cluster Headache (CH) will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years of age&#xD;
&#xD;
          -  Affiliated or entitled to a Social Security scheme&#xD;
&#xD;
          -  Resident in the territories of the hospital grouping of Loire territory (located less&#xD;
             than 50 km away)&#xD;
&#xD;
          -  Whose diagnosis of episodic or chronic Cluster Headache (CH) has been confirmed&#xD;
             according to International Classification of Headache Disorders (ICHD)- 3 criteria&#xD;
&#xD;
          -  With a regular sinus rhythm and heart rate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conditions contraindicating the use of injectable sumatriptan&#xD;
&#xD;
          -  Conditions likely to affect the Autonomic Nervous System (ANS): dysautonomic sensory&#xD;
             neuropathies, sleep apnea syndrome, etc.&#xD;
&#xD;
          -  Cognitive or language disorders that may interfere with pain assessment and seizure&#xD;
             follow-up.&#xD;
&#xD;
          -  Patients taking treatments that may modify the Autonomic Nervous System (ANS):&#xD;
             catecholamine (adrenaline, noradrenaline, dopamine), B-stimulants (isoprenaline,&#xD;
             dobutamine, dopexamine, salbutamol, terbutaline, fenoterol, orciprenaline,&#xD;
             clenbuterol, salmeterol, formoterol), B-blockers, alpha-stimulants (midodrine,&#xD;
             alpha-methyl-dopa, clonidine, rilmenidine, moxonidine), alpha-blockers (phentolamine,&#xD;
             prazosin, urapidil), amphetamine, tyramine, ephedrine, selegiline, cocaine,&#xD;
             imipramine.&#xD;
&#xD;
          -  Impossibility to submit to the medical follow-up of the program for geographical,&#xD;
             social or psychological reasons.&#xD;
&#xD;
          -  Patient deprived of liberty or under guardianship.&#xD;
&#xD;
          -  Patient with preventive background treatment of Cluster Headache (CH).&#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>Christelle CREAC'H, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christelle CREAC'H, MD</last_name>
    <phone>(0)4.77.12.76.48</phone>
    <phone_ext>+33</phone_ext>
    <email>christelle.creach@chu-st-etienne.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fleur PETIT, CRA</last_name>
    <phone>(0)4.77.82.95.58</phone>
    <phone_ext>+33</phone_ext>
    <email>Fleur.Petit@chu-st-etienne.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christelle CREAC'H, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roland PEYRON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Malou NAVEZ, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Béatrice LIETAR, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Claude BARTHELEMY, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Frédéric ROCHE, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David CHARIER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cluster Headache</keyword>
  <keyword>Autonomic Nervous System</keyword>
  <keyword>Seizure</keyword>
  <keyword>Holter</keyword>
  <keyword>Electrocardiogram</keyword>
  <keyword>(LF/HF) ratio</keyword>
  <keyword>Daytime seizure</keyword>
  <keyword>Night seizure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cluster Headache</mesh_term>
    <mesh_term>Headache</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/NCT04439409
org study id: 19CH103
secondary id: 2019-A01343-54
nct id: NCT04439409
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cluster Headache (CH) is associated with ipsilateral vegetative signs, related to
      parasympathetic system hyperactivity and/or signs of sympathetic hypoactivity. The precise
      mechanism of Cluster Headache (CH) is still unknown. The question is whether these
      dysautonomic disorders are simply secondary to the Cluster Headache (CH) process or whether
      they are the triggering factor.
This study cares about the evolution of the Autonomic Nervous System (ANS) in Cluster
      Headache (CH) seizures. Patients will be offered Holter ECG to study the temporal
      relationships between changes in Autonomic Nervous System (ANS) activity during Headache (CH)
      seizures and changes in Autonomic Nervous System (ANS) activity before and after seizure
      treatment, using heart rate variability measurement.

      The hypothesis is that there would be an initial temporary sympathetic activation, followed
      quickly by parasympathetic hyperactivation and a return to a state of equilibrium.
observational model: Other
time perspective: Prospective
measure: Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure
time frame: Day: 7
description: Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure during the basal period, pre-seizure, seizure and after the seizure.
measure: Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure
time frame: Day: 7
description: Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure during the basal period, pre-seizure, seizure and after the seizure.
measure: Low Frequency during daytime and night seizure
time frame: Day: 7
description: Comparison of measure of Low Frequency during daytime and night seizure.
measure: High Frequency (HF) during daytime and night seizure
time frame: Day: 7
description: Comparison of measure of High Frequency (HF) during daytime and night seizure.
measure: Correlation between several parameters
time frame: Day: 7
description: Correlation between Heart Rate Variability (HRV), changes in the Low Frequency/High Frequency (LF/HF) ratio, the Low Frequency (LF) and the High Frequency (HF), and the intensity of pain measured on the Visual Analog Scale (VAS).
arm group label: Patients with Cluster Headache (CH)
description: Patients with Cluster Headache (CH) will be included. They will have a Holter electrocardiogram during 7 days.
intervention type: Device
intervention name: Holter electrocardiogram
description: Holter electrocardiogram will be carried during 7 days to measure heart's electrical activity continuously.
arm group label: Patients with Cluster Headache (CH)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christelle CREAC'H, MD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
last name: Christelle CREAC'H, MD
phone: (0)4.77.12.76.48
phone ext: +33
email: christelle.creach@chu-st-etienne.fr
last name: Fleur PETIT, CRA
phone: (0)4.77.82.95.58
phone ext: +33
email: Fleur.Petit@chu-st-etienne.fr
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Cluster Headache
mesh term: Headache
sharing ipd: No