xml: <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/NCT05967065</url>
    </required_header>
    <id_info>
      <org_study_id>RegionStockholm</org_study_id>
      <nct_id>NCT05967065</nct_id>
    </id_info>
    <brief_title>Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone B250 Skull Vibration Protocol</brief_title>
    <acronym>VIN by B250</acronym>
    <official_title>Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Stockholm</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Region Stockholm</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>
        to study the videonystagmography response to a bone conducted vibration on the mastoid by&#xD;
        B250 bone transducer in patients affected by vestibular loss, Menieres disease and Superior&#xD;
        Semicircular Canal Dehiscence Syndrome vs healthy control subjects&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>measure of eye movements</measure>
      <time_frame>through study completion, an average of 18 months</time_frame>
      <description>angular velocity of eye movements during skull vibration.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Superior Canal Dehiscence Syndrome</condition>
    <condition>Vestibular Disorder</condition>
    <arm_group>
      <arm_group_label>Vestibular disorders</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients uppfilling vestibular disorders diagnostic criterias</description>
    </arm_group>
    <arm_group>
      <arm_group_label>healthy control subjects</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients without past or ongoing vestibular or balance disorders</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>vibration induced nystagmus test</intervention_name>
      <description>Vibration induced nystagmus test by bone transducer B250.</description>
      <arm_group_label>Vestibular disorders</arm_group_label>
      <arm_group_label>healthy control subjects</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients affected by certain vestibular disorders.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with vertigo and dizziness without certain diagnosis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Luca Verrecchia, MD PhD</last_name>
      <phone>+46724654523</phone>
      <email>luca.verrecchia@ki.se</email>
    </overall_contact>
    <location>
      <facility>
        <name>Karolinska University Hospital, Hearing and Balance Unit</name>
        <address>
          <city>Stockholm</city>
          <zip>14186</zip>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luca Verrecchia, MD PhD</last_name>
        <phone>0046724654523</phone>
        <email>luca.verrecchia@ki.se</email>
      </contact>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 1, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Region Stockholm</investigator_affiliation>
      <investigator_full_name>Luca Verrecchia</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vestibular Diseases</mesh_term>
      <mesh_term>Semicircular Canal Dehiscence</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967065
  org study id: RegionStockholm
  nct id: NCT05967065
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  to study the videonystagmography response to a bone conducted vibration on the mastoid by
        B250 bone transducer in patients affected by vestibular loss, Menieres disease and Superior
        Semicircular Canal Dehiscence Syndrome vs healthy control subjects
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: measure of eye movements
  time frame: through study completion, an average of 18 months
  description: angular velocity of eye movements during skull vibration.
  arm group label: Vestibular disorders
  arm group type: Other
  description: Patients uppfilling vestibular disorders diagnostic criterias
  arm group label: healthy control subjects
  arm group type: Other
  description: Patients without past or ongoing vestibular or balance disorders
  intervention type: Diagnostic Test
  intervention name: vibration induced nystagmus test
  description: Vibration induced nystagmus test by bone transducer B250.
  arm group label: Vestibular disorders
  arm group label: healthy control subjects
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Luca Verrecchia, MD PhD
  phone: +46724654523
  email: luca.verrecchia@ki.se
  facility: 
  status: Recruiting
  contact: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Region Stockholm
  investigator full name: Luca Verrecchia
  investigator title: Principal investigator
  mesh term: Vestibular Diseases
  mesh term: Semicircular Canal Dehiscence