<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/NCT01693809</url>
  </required_header>
  <id_info>
    <org_study_id>0127/11</org_study_id>
    <nct_id>NCT01693809</nct_id>
  </id_info>
  <brief_title>The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy Subjects</brief_title>
  <official_title>The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital do Servidor Publico Estadual</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital do Servidor Publico Estadual</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The principal aim of this study is to evaluate the presence of changes in cervical vestibular&#xD;
      evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy subjects.&#xD;
&#xD;
      Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service&#xD;
      of the hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Anticipated">October 2012</primary_completion_date>
  <phase>Phase 4</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>Screening</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake.</measure>
    <time_frame>60 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Caffeine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caffeine 420mg, one time</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Caffeine</intervention_name>
    <arm_group_label>Caffeine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hearing impairment&#xD;
&#xD;
          -  caffeine abuse 24 hours before the test&#xD;
&#xD;
          -  medication remains&#xD;
&#xD;
          -  hypertension, dyslipidemia, diabetes mellitus or sleep disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabio Akira Suzuki, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital do Servidor Publico Estadual</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ana Maria Almeida Sousa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital do Servidor Publico Estadual</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital do Servidor Publico Estadual</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 29, 2012</last_update_submitted>
  <last_update_submitted_qc>September 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital do Servidor Publico Estadual</investigator_affiliation>
    <investigator_full_name>Ana Maria Almeida de Sousa</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Caffeine</keyword>
  <keyword>Vestibular Evoked Myogenic Potentials</keyword>
  <keyword>dizziness</keyword>
  <keyword>vertigo</keyword>
  <keyword>tinnitus</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_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/NCT01693809
org study id: 0127/11
nct id: NCT01693809
lead sponsor: 
has dmc: Yes
The principal aim of this study is to evaluate the presence of changes in cervical vestibular
      evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy subjects.

      Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service
      of the hospital.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: Single (Investigator)
measure: Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake.
time frame: 60 minutes
arm group label: Caffeine
arm group type: Experimental
description: Caffeine 420mg, one time
intervention type: Drug
intervention name: Caffeine
arm group label: Caffeine
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fabio Akira Suzuki, PhD
role: Study Chair
affiliation: Hospital do Servidor Publico Estadual
last name: Ana Maria Almeida Sousa, MD
role: Principal Investigator
affiliation: Hospital do Servidor Publico Estadual
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital do Servidor Publico Estadual
investigator full name: Ana Maria Almeida de Sousa
investigator title: MD
mesh term: Caffeine