<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/NCT03020654</url>
  </required_header>
  <id_info>
    <org_study_id>STH19451</org_study_id>
    <secondary_id>5375</secondary_id>
    <nct_id>NCT03020654</nct_id>
  </id_info>
  <brief_title>The Use of Virtual Reality for the Treatment of Visual Vertigo.</brief_title>
  <official_title>The Use of Virtual Reality for the Treatment of Visual Vertigo.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the use of virtual environments presented on a head mounted display&#xD;
      for the rehabilitation of those suffering with visual vertigo.&#xD;
&#xD;
      The control group and treatment groups will be presented with two different sets of&#xD;
      environments and be given the same head and eye exercises to complete within the environment.&#xD;
      They will also be provided with at home exercises to complete.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visual vertigo occurs after the balance system suffers damage (e.g after a viral infection&#xD;
      such as labyrinthitis). This causes an over-reliance on the eyes to maintain balance which&#xD;
      causes disorientation in busy environments such as the supermarket. The treatment involves&#xD;
      trying to desensitise the individual to visually stimulating situations. Further head and eye&#xD;
      exercises are completed alongside the exposure to overcome the damage done to the balance&#xD;
      system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">November 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in scoring on the Situational Characteristic Questionnaire</measure>
    <time_frame>Week 1 and Week 6</time_frame>
    <description>A measure of visual vertigo symptom level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in scoring on the PHQ-9 Questionnaire from week one to six</measure>
    <time_frame>Week 1 and Week 6</time_frame>
    <description>A measure of depression symptom level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scoring on the GAD-7 Questionnaire from week one to six</measure>
    <time_frame>Week 1 and Week 6</time_frame>
    <description>A measure of anxiety symptom level</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subjective questionnaire</measure>
    <time_frame>Week 6</time_frame>
    <description>A likert scale based questionnaire assessing acceptability of treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in head tracking observed at each weekly session for six weeks through numerical data extracted from the headset to show displacement of the head in the x, y and z planes of movement.</measure>
    <time_frame>Week 1, 2, 3, 4, 5 and 6</time_frame>
    <description>Analysis of the head movement within each environment each week to see if there is any improvement</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Treatment of Visual Vertigo</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual environment with fast moving objects these are graded in intensity from 1-7. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Virtual environment with no movement graded at grade 0. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual environment with fast moving objects</intervention_name>
    <description>A beach/park environment with graded moving objects, the individual will complete head and eye exercises.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual environment with no movement</intervention_name>
    <description>A beach/park environment with static objects, the individual will complete head and eye exercises.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those who have been diagnosed with visual vertigo and have scored a significant level&#xD;
             on the Situational Characteristic Questionnaire (over 0.74 as per Pavlou et al.,&#xD;
             2006).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with or under investigation for epilepsy.&#xD;
&#xD;
          -  Those who have been determined to have no or limited balance function in both ears.&#xD;
&#xD;
          -  Those with reduced visual acuity that will leave them unable to view the 3D effects of&#xD;
             the head mounted display.&#xD;
&#xD;
          -  Those with severe mental health disorders e.g. psychosis, paranoid disorders, bipolar&#xD;
             disorder or a history of substance abuse.&#xD;
&#xD;
          -  Severe neck pain/ restricted movement.&#xD;
&#xD;
          -  Previous treatment for visual vertigo.&#xD;
&#xD;
          -  Those with an fluctuating vestibular disorder such as Ménière's disease or vestibular&#xD;
             migraine.&#xD;
&#xD;
          -  Those with untreated Benign Paroxymal Positional Vertigo (BPPV).&#xD;
&#xD;
          -  Those with a significant brain injury, or head injury that results in a central&#xD;
             vestibular disorder.&#xD;
&#xD;
          -  Those with an arrhythmia.&#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>Kirsty M Walker, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kirsty M Walker, BSc</last_name>
    <phone>011427112131</phone>
    <email>kirsty.walker@sth.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Paul Bacon, PhD</last_name>
    <phone>01142712145</phone>
    <email>paul.bacon@sth.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirsty M Walker, BSc</last_name>
      <phone>01142712131</phone>
      <email>kirsty.walker@sth.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Paul Bacon, PhD</last_name>
      <phone>01142712145</phone>
      <email>paul.bacon@sth.nhs.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 12, 2018</last_update_submitted>
  <last_update_submitted_qc>April 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2018</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/NCT03020654
org study id: STH19451
secondary id: 5375
nct id: NCT03020654
lead sponsor: 
collaborator: 
has dmc: Yes
This study investigates the use of virtual environments presented on a head mounted display
      for the rehabilitation of those suffering with visual vertigo.

      The control group and treatment groups will be presented with two different sets of
      environments and be given the same head and eye exercises to complete within the environment.
      They will also be provided with at home exercises to complete.
Visual vertigo occurs after the balance system suffers damage (e.g after a viral infection
      such as labyrinthitis). This causes an over-reliance on the eyes to maintain balance which
      causes disorientation in busy environments such as the supermarket. The treatment involves
      trying to desensitise the individual to visually stimulating situations. Further head and eye
      exercises are completed alongside the exposure to overcome the damage done to the balance
      system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in scoring on the Situational Characteristic Questionnaire
time frame: Week 1 and Week 6
description: A measure of visual vertigo symptom level
measure: Change in scoring on the PHQ-9 Questionnaire from week one to six
time frame: Week 1 and Week 6
description: A measure of depression symptom level
measure: Change in scoring on the GAD-7 Questionnaire from week one to six
time frame: Week 1 and Week 6
description: A measure of anxiety symptom level
measure: Subjective questionnaire
time frame: Week 6
description: A likert scale based questionnaire assessing acceptability of treatment
measure: Change in head tracking observed at each weekly session for six weeks through numerical data extracted from the headset to show displacement of the head in the x, y and z planes of movement.
time frame: Week 1, 2, 3, 4, 5 and 6
description: Analysis of the head movement within each environment each week to see if there is any improvement
arm group label: Treatment group
arm group type: Experimental
description: Virtual environment with fast moving objects these are graded in intensity from 1-7. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.
arm group label: Control group
arm group type: Active Comparator
description: Virtual environment with no movement graded at grade 0. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.
intervention type: Other
intervention name: Virtual environment with fast moving objects
description: A beach/park environment with graded moving objects, the individual will complete head and eye exercises.
arm group label: Treatment group
intervention type: Other
intervention name: Virtual environment with no movement
description: A beach/park environment with static objects, the individual will complete head and eye exercises.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kirsty M Walker, BSc
role: Principal Investigator
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
last name: Kirsty M Walker, BSc
phone: 011427112131
email: kirsty.walker@sth.nhs.uk
last name: Paul Bacon, PhD
phone: 01142712145
email: paul.bacon@sth.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Dizziness
sharing ipd: No