<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/NCT04447066</url>
  </required_header>
  <id_info>
    <org_study_id>255-20</org_study_id>
    <nct_id>NCT04447066</nct_id>
  </id_info>
  <brief_title>The Prevalence of Semicircular Canal Dysfunction Among Rehabilitation Patients</brief_title>
  <official_title>Semicircular Canals Dysfunction Among Patients Hospitalized at the Rehabilitation Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients hospitalized at the rehabilitation department at the hospital will fill a&#xD;
      questionnaire regarding dizziness and ear diseases, and the Dizziness Handicap Inventory, and&#xD;
      then will be examined by an ENT physician, followed by a video Head Impulse Test (vHIT)&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Video Head Impulse Test (vHIT) results</measure>
    <time_frame>1 year</time_frame>
    <description>The results of the vHIT study in terms of gain and saccades</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Vertigo</condition>
  <condition>Dizziness</condition>
  <arm_group>
    <arm_group_label>Patients hospitalized at the rehabilitation department</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention - VHIT will be used but without intervention</description>
    <arm_group_label>Patients hospitalized at the rehabilitation department</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized at the rehabilitation department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 65 years old&#xD;
&#xD;
          -  Hospitalized at the rehabilitation department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blindness or loss of vision which is not corrected using glasses&#xD;
&#xD;
          -  Past CVA with neurological remnants&#xD;
&#xD;
          -  Movement disorder&#xD;
&#xD;
          -  Lower body part weakness&#xD;
&#xD;
          -  Limitation in neck movement&#xD;
&#xD;
          -  Vestibular pathology diagnosed in the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yahav Oron, MD</last_name>
    <phone>+972-6973573</phone>
    <email>oron.yahav@gmail.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Dizziness</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/NCT04447066
org study id: 255-20
nct id: NCT04447066
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Patients hospitalized at the rehabilitation department at the hospital will fill a
      questionnaire regarding dizziness and ear diseases, and the Dizziness Handicap Inventory, and
      then will be examined by an ENT physician, followed by a video Head Impulse Test (vHIT)
      study.
observational model: Cohort
time perspective: Cross-Sectional
measure: Video Head Impulse Test (vHIT) results
time frame: 1 year
description: The results of the vHIT study in terms of gain and saccades
arm group label: Patients hospitalized at the rehabilitation department
intervention type: Other
intervention name: No intervention
description: No intervention - VHIT will be used but without intervention
arm group label: Patients hospitalized at the rehabilitation department
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Yahav Oron, MD
phone: +972-6973573
email: oron.yahav@gmail.com
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Dizziness
sharing ipd: No