<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/NCT03821155</url>
  </required_header>
  <id_info>
    <org_study_id>2018-166</org_study_id>
    <nct_id>NCT03821155</nct_id>
  </id_info>
  <brief_title>Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?</brief_title>
  <official_title>Which Treatment is Most Effective When Treating Vestibular Neuritis: Corticosteroid Treatment Alone or Combined Corticosteroid Treatment and Vestibular Rehabilitation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aalborg University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate which treatment option (corticosteroid treatment alone or combined&#xD;
      corticosteroid treatment and vestibular rehabilitation) is the most effective in patients&#xD;
      diagnosed with vestibular neuritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient&#xD;
      will undergo randomization for a specific treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients randomized to two different treatments:&#xD;
corticosteroid treatment (&quot;prednisolone&quot;)&#xD;
combined corticosteroid treatment (&quot;prednisolone&quot;) and vestibular rehabilitation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Suppressing head impulse paradigm (SHIMP)</measure>
    <time_frame>6 month</time_frame>
    <description>SHIMP equipment will objectively quantify change of vestibular function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective visual vertical (SVV)</measure>
    <time_frame>6 month</time_frame>
    <description>SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Video head impulse test (v-HIT)</measure>
    <time_frame>6 month</time_frame>
    <description>v-HIT equipment will objectively quantify change of vestibular function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dizziness handicap inventory (DHI) questionnaire</measure>
    <time_frame>6 month</time_frame>
    <description>Fulfillment of the questionnaire &quot;Dizziness Handicap Inventory&quot; (DHI) will quantify the level of experienced vertigo.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Vestibular Neuritis</condition>
  <arm_group>
    <arm_group_label>Neuritis vestibularis (group 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Corticosteroid (&quot;prednisolone&quot;)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neuritis vestibularis (group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Corticosteroid (&quot;prednisolone&quot;) + vestibular rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vestibular rehabilitation</intervention_name>
    <description>Specialized physical therapy aimed at restoring balance</description>
    <arm_group_label>Neuritis vestibularis (group 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid</intervention_name>
    <description>Prednisolone</description>
    <arm_group_label>Neuritis vestibularis (group 1)</arm_group_label>
    <arm_group_label>Neuritis vestibularis (group 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age above 18 years of age&#xD;
&#xD;
          2. Medical history compatible with vestibular neuritis&#xD;
&#xD;
          3. Verification of vestibular neuritis with positive romberg test, pathological v-HIT and&#xD;
             horizontal nystagmus with a rotatory component.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Former medical history with vestibular dysfunction&#xD;
&#xD;
          2. Medical history or objective signs of cochlear dysfunction before, during or after&#xD;
             onset of vestibular neuritis&#xD;
&#xD;
          3. Onset of symptoms 14 days before recruitment to the study&#xD;
&#xD;
          4. Focal neurological symptoms/signs&#xD;
&#xD;
          5. Contraindication to prednisolone treatment&#xD;
&#xD;
          6. Problem with participating in vestibular rehabilitation due to muscular-skeletal&#xD;
             disease ect.&#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>Dan D Hougaard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aalborg University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin H Wolder, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aalborg University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Otolaryngology, Head &amp; Neck Surgery and Audiology</name>
      <address>
        <city>Aalborg</city>
        <state>North Denmark Region</state>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University Hospital</investigator_affiliation>
    <investigator_full_name>Dan Dupont Hougaard</investigator_full_name>
    <investigator_title>MD, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Vestibular Neuritis</keyword>
  <keyword>SHIMP (suppressing head impulse paradigm)</keyword>
  <keyword>SVV (subjective visual vertical)</keyword>
  <keyword>Vestibular rehabilitation</keyword>
  <keyword>Prednisolone</keyword>
  <keyword>v-HIT (video head impulse test)</keyword>
  <keyword>Vestibular Neuronitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vestibular Neuronitis</mesh_term>
    <mesh_term>Neuritis</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/NCT03821155
org study id: 2018-166
nct id: NCT03821155
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate which treatment option (corticosteroid treatment alone or combined
      corticosteroid treatment and vestibular rehabilitation) is the most effective in patients
      diagnosed with vestibular neuritis.
Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient
      will undergo randomization for a specific treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients randomized to two different treatments:
corticosteroid treatment ("prednisolone")
combined corticosteroid treatment ("prednisolone") and vestibular rehabilitation
primary purpose: Treatment
masking: None (Open Label)
measure: Suppressing head impulse paradigm (SHIMP)
time frame: 6 month
description: SHIMP equipment will objectively quantify change of vestibular function.
measure: Subjective visual vertical (SVV)
time frame: 6 month
description: SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function
measure: Video head impulse test (v-HIT)
time frame: 6 month
description: v-HIT equipment will objectively quantify change of vestibular function.
measure: Dizziness handicap inventory (DHI) questionnaire
time frame: 6 month
description: Fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.
arm group label: Neuritis vestibularis (group 1)
arm group type: Active Comparator
description: Corticosteroid ("prednisolone")
arm group label: Neuritis vestibularis (group 2)
arm group type: Experimental
description: Corticosteroid ("prednisolone") + vestibular rehabilitation
intervention type: Other
intervention name: Vestibular rehabilitation
description: Specialized physical therapy aimed at restoring balance
arm group label: Neuritis vestibularis (group 2)
intervention type: Drug
intervention name: Corticosteroid
description: Prednisolone
arm group label: Neuritis vestibularis (group 1)
arm group label: Neuritis vestibularis (group 2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dan D Hougaard, MD
role: Principal Investigator
affiliation: Aalborg University Hospital
last name: Martin H Wolder, MS
role: Principal Investigator
affiliation: Aalborg University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University Hospital
investigator full name: Dan Dupont Hougaard
investigator title: MD, Assistant Professor
mesh term: Vestibular Neuronitis
mesh term: Neuritis
sharing ipd: No