<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/NCT04436783</url>
  </required_header>
  <id_info>
    <org_study_id>REB19-1367</org_study_id>
    <nct_id>NCT04436783</nct_id>
  </id_info>
  <brief_title>Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo</brief_title>
  <official_title>Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</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>
      Background and Rationale:&#xD;
&#xD;
      Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, affecting&#xD;
      2.4% of the general population and 30% of those over 70 years old. The main symptom is the&#xD;
      perceived sensation of movement of the surrounding or self, without actual such movement,&#xD;
      triggered by changes in position (positional vertigo). It can be dangerous as repetitive&#xD;
      symptoms can lead to falls and depression, particularly in the elderly. Additionally, at&#xD;
      least half of those with initial symptoms of BPPV will have ongoing symptoms if not treated.&#xD;
      The Epley maneuver is a particle-repositioning maneuver that is used to treat posterior&#xD;
      semicircular canal BPPV, the most common type of BPPV, after a diagnosis has been made on&#xD;
      physical examination. In-office administration of the Epley maneuver by a specialist yields a&#xD;
      90% success rate at treating the condition; however, at-home administration is much less&#xD;
      successful. In a previous paper we demonstrated the development and face validation of a&#xD;
      Virtual Reality Epley Maneuver System (VREMS) for performing the Epley maneuver correctly. In&#xD;
      this study we aim to apply VREMS treatment in patients who have been diagnosed with BPPV.&#xD;
&#xD;
      Research Question and Objectives:&#xD;
&#xD;
      PICO (Patient/Population Intervention Compare Outcome): In adult patients diagnosed with&#xD;
      posterior canal BPPV by a specialist, does VREMS, as compared to self-performed Epley&#xD;
      maneuver using an instructional handout (IH) result in improved or resolved symptoms?&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Vertigo patients referred to the Neurovestibular Clinic will be evaluated by an Ear, Nose and&#xD;
      Throat (ENT) specialist. Those who are diagnosed with posterior canal BPPV after history and&#xD;
      physical examination including the Dix-Hallpike test will be approached to be recruited into&#xD;
      the study. Patients who consent to participating in the study will be allocated to either the&#xD;
      VREMS cohort or the control cohort. Those in the control cohort will be provided an&#xD;
      instructional handout (IH) to help them perform the Epley maneuver. Patients in the VREMS&#xD;
      cohort will be provided with the VREMS device, which will help guide them through the Epley&#xD;
      maneuver in a virtual reality environment. All participants will be asked to rate the&#xD;
      severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will&#xD;
      be supervised as they perform the Epley maneuver - VREMS assisted or based on reading the IH.&#xD;
      In both groups, once the patient has performed the Epley maneuver (whether with VREMS&#xD;
      assistance or with the IH), they will be asked to rate their symptom severity after&#xD;
      undergoing the Epley maneuver. All patients will also be asked to complete the NASA Task Load&#xD;
      Index (NASA-TLX) to gauge their perceived mental workload. They will also be given an&#xD;
      opportunity to give free-text feedback. For any patient with residual BPPV symptoms following&#xD;
      Epley maneuver with VREMS or IH, the ENT specialist/vestibular physiotherapist will perform&#xD;
      the Epley maneuver to ensure resolution of symptoms if possible prior to discharge from the&#xD;
      clinic. The primary outcome of the study will be the improvement in and resolution of BPPV&#xD;
      symptoms with VREMS use as compared to IH. Secondary outcome will be mental workload in each&#xD;
      of the study arms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">November 14, 2022</start_date>
  <completion_date type="Anticipated">October 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective dizziness</measure>
    <time_frame>Self reported once immediately before performing the Epley maneuver and once immediately after - in both arms</time_frame>
    <description>Patient reported dizziness score out of 10 - Min value 0(no dizziness) and max value 10 (completely debilitating dizziness). The higher the score, the greater the subjective dizziness (worse outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mental demand</measure>
    <time_frame>Reported once immediately before performing the Epley maneuver and once immediately after - in both arms</time_frame>
    <description>Mental demand reported using the National Aeronautics and Space Administration (NASA) - Task Load Index - Minimum score 0 (no mental demand) and maximum score is 100 (very high mental demand). The higher the score, the greater the mental demand (worse outcome).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>BPPV</condition>
  <condition>Vertigo, Peripheral</condition>
  <arm_group>
    <arm_group_label>Virtual Reality Epley Maneuver System - VREMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment. All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted. In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Instructional Handout (IH)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver. They will be given a chance to review the IH, and then they will have a chance to perform the Epley maneuver.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality Epley Maneuver System (VREMS)</intervention_name>
    <description>The VREMS system includes a smartphone placed inside virtual reality goggles worn by the participant. On the smartphone there is a virtual reality application. When viewed through the VR goggles the participants see a three-dimensional environment. Audio and text cues are presented in a 3D environment to help guide the patient through the Epley maneuver.</description>
    <arm_group_label>Virtual Reality Epley Maneuver System - VREMS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Instructional Handout (IH)</intervention_name>
    <description>Patients randomized to the IH group will be given an instructional handout with image and text-based instructions on the steps involved in performing the Epley maneuver. They will then be given the chance to perform the Epley maneuver.</description>
    <arm_group_label>Instructional Handout (IH)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (over 18 years old)&#xD;
&#xD;
          -  Clinical diagnosis of posterior semicircular canal benign paroxysmal positional&#xD;
             vertigo&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodynamically unstable&#xD;
&#xD;
          -  Cervical spine instability&#xD;
&#xD;
          -  Limited neck range of motion&#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>Euna Hwang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reza Tabanfar, MD</last_name>
    <phone>5879683027</phone>
    <email>rezatabanfar@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Hanley K, O'Dowd T, Considine N. A systematic review of vertigo in primary care. Br J Gen Pract. 2001 Aug;51(469):666-71.</citation>
    <PMID>11510399</PMID>
  </reference>
  <reference>
    <citation>Kuo CH, Pang L, Chang R. Vertigo - part 1 - assessment in general practice. Aust Fam Physician. 2008 May;37(5):341-7.</citation>
    <PMID>18464964</PMID>
  </reference>
  <reference>
    <citation>Strupp M, Brandt T. Diagnosis and treatment of vertigo and dizziness. Dtsch Arztebl Int. 2008 Mar;105(10):173-80. doi: 10.3238/arztebl.2008.0173. Epub 2008 Mar 7.</citation>
    <PMID>19629221</PMID>
  </reference>
  <reference>
    <citation>von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.</citation>
    <PMID>17135456</PMID>
  </reference>
  <reference>
    <citation>Hall SF, Ruby RR, McClure JA. The mechanics of benign paroxysmal vertigo. J Otolaryngol. 1979 Apr;8(2):151-8.</citation>
    <PMID>430582</PMID>
  </reference>
  <reference>
    <citation>Gopinath B, McMahon CM, Rochtchina E, Mitchell P. Dizziness and vertigo in an older population: the Blue Mountains prospective cross-sectional study. Clin Otolaryngol. 2009 Dec;34(6):552-6. doi: 10.1111/j.1749-4486.2009.02025.x.</citation>
    <PMID>20070765</PMID>
  </reference>
  <reference>
    <citation>Neuhauser HK, Radtke A, von Brevern M, Lezius F, Feldmann M, Lempert T. Burden of dizziness and vertigo in the community. Arch Intern Med. 2008 Oct 27;168(19):2118-24. doi: 10.1001/archinte.168.19.2118. Erratum In: Arch Intern Med. 2009 Jan 12;169(1):89.</citation>
    <PMID>18955641</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 14, 2021</last_update_submitted>
  <last_update_submitted_qc>June 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Euna Hwang</investigator_full_name>
    <investigator_title>Otolaryngologist</investigator_title>
  </responsible_party>
  <keyword>BPPV</keyword>
  <keyword>Vertigo</keyword>
  <keyword>Peripheral vestibular disorder</keyword>
  <keyword>Virtual reality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Benign Paroxysmal Positional 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/NCT04436783
org study id: REB19-1367
nct id: NCT04436783
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background and Rationale:

      Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, affecting
      2.4% of the general population and 30% of those over 70 years old. The main symptom is the
      perceived sensation of movement of the surrounding or self, without actual such movement,
      triggered by changes in position (positional vertigo). It can be dangerous as repetitive
      symptoms can lead to falls and depression, particularly in the elderly. Additionally, at
      least half of those with initial symptoms of BPPV will have ongoing symptoms if not treated.
      The Epley maneuver is a particle-repositioning maneuver that is used to treat posterior
      semicircular canal BPPV, the most common type of BPPV, after a diagnosis has been made on
      physical examination. In-office administration of the Epley maneuver by a specialist yields a
      90% success rate at treating the condition; however, at-home administration is much less
      successful. In a previous paper we demonstrated the development and face validation of a
      Virtual Reality Epley Maneuver System (VREMS) for performing the Epley maneuver correctly. In
      this study we aim to apply VREMS treatment in patients who have been diagnosed with BPPV.

      Research Question and Objectives:

      PICO (Patient/Population Intervention Compare Outcome): In adult patients diagnosed with
      posterior canal BPPV by a specialist, does VREMS, as compared to self-performed Epley
      maneuver using an instructional handout (IH) result in improved or resolved symptoms?

      Methods:

      Vertigo patients referred to the Neurovestibular Clinic will be evaluated by an Ear, Nose and
      Throat (ENT) specialist. Those who are diagnosed with posterior canal BPPV after history and
      physical examination including the Dix-Hallpike test will be approached to be recruited into
      the study. Patients who consent to participating in the study will be allocated to either the
      VREMS cohort or the control cohort. Those in the control cohort will be provided an
      instructional handout (IH) to help them perform the Epley maneuver. Patients in the VREMS
      cohort will be provided with the VREMS device, which will help guide them through the Epley
      maneuver in a virtual reality environment. All participants will be asked to rate the
      severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will
      be supervised as they perform the Epley maneuver - VREMS assisted or based on reading the IH.
      In both groups, once the patient has performed the Epley maneuver (whether with VREMS
      assistance or with the IH), they will be asked to rate their symptom severity after
      undergoing the Epley maneuver. All patients will also be asked to complete the NASA Task Load
      Index (NASA-TLX) to gauge their perceived mental workload. They will also be given an
      opportunity to give free-text feedback. For any patient with residual BPPV symptoms following
      Epley maneuver with VREMS or IH, the ENT specialist/vestibular physiotherapist will perform
      the Epley maneuver to ensure resolution of symptoms if possible prior to discharge from the
      clinic. The primary outcome of the study will be the improvement in and resolution of BPPV
      symptoms with VREMS use as compared to IH. Secondary outcome will be mental workload in each
      of the study arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Subjective dizziness
time frame: Self reported once immediately before performing the Epley maneuver and once immediately after - in both arms
description: Patient reported dizziness score out of 10 - Min value 0(no dizziness) and max value 10 (completely debilitating dizziness). The higher the score, the greater the subjective dizziness (worse outcome).
measure: Mental demand
time frame: Reported once immediately before performing the Epley maneuver and once immediately after - in both arms
description: Mental demand reported using the National Aeronautics and Space Administration (NASA) - Task Load Index - Minimum score 0 (no mental demand) and maximum score is 100 (very high mental demand). The higher the score, the greater the mental demand (worse outcome).
arm group label: Virtual Reality Epley Maneuver System - VREMS
arm group type: Experimental
description: Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment. All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted. In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver
arm group label: Instructional Handout (IH)
arm group type: Active Comparator
description: Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver. They will be given a chance to review the IH, and then they will have a chance to perform the Epley maneuver.
intervention type: Device
intervention name: Virtual Reality Epley Maneuver System (VREMS)
description: The VREMS system includes a smartphone placed inside virtual reality goggles worn by the participant. On the smartphone there is a virtual reality application. When viewed through the VR goggles the participants see a three-dimensional environment. Audio and text cues are presented in a 3D environment to help guide the patient through the Epley maneuver.
arm group label: Virtual Reality Epley Maneuver System - VREMS
intervention type: Other
intervention name: Instructional Handout (IH)
description: Patients randomized to the IH group will be given an instructional handout with image and text-based instructions on the steps involved in performing the Epley maneuver. They will then be given the chance to perform the Epley maneuver.
arm group label: Instructional Handout (IH)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Euna Hwang, MD
role: Principal Investigator
affiliation: University of Calgary
last name: Reza Tabanfar, MD
phone: 5879683027
email: rezatabanfar@gmail.com
citation: Hanley K, O'Dowd T, Considine N. A systematic review of vertigo in primary care. Br J Gen Pract. 2001 Aug;51(469):666-71.
PMID: 11510399
citation: Kuo CH, Pang L, Chang R. Vertigo - part 1 - assessment in general practice. Aust Fam Physician. 2008 May;37(5):341-7.
PMID: 18464964
citation: Strupp M, Brandt T. Diagnosis and treatment of vertigo and dizziness. Dtsch Arztebl Int. 2008 Mar;105(10):173-80. doi: 10.3238/arztebl.2008.0173. Epub 2008 Mar 7.
PMID: 19629221
citation: von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
PMID: 17135456
citation: Hall SF, Ruby RR, McClure JA. The mechanics of benign paroxysmal vertigo. J Otolaryngol. 1979 Apr;8(2):151-8.
PMID: 430582
citation: Gopinath B, McMahon CM, Rochtchina E, Mitchell P. Dizziness and vertigo in an older population: the Blue Mountains prospective cross-sectional study. Clin Otolaryngol. 2009 Dec;34(6):552-6. doi: 10.1111/j.1749-4486.2009.02025.x.
PMID: 20070765
citation: Neuhauser HK, Radtke A, von Brevern M, Lezius F, Feldmann M, Lempert T. Burden of dizziness and vertigo in the community. Arch Intern Med. 2008 Oct 27;168(19):2118-24. doi: 10.1001/archinte.168.19.2118. Erratum In: Arch Intern Med. 2009 Jan 12;169(1):89.
PMID: 18955641
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Euna Hwang
investigator title: Otolaryngologist
mesh term: Vertigo
mesh term: Benign Paroxysmal Positional Vertigo
mesh term: Dizziness
sharing ipd: No