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/NCT06022367</url>
    </required_header>
    <id_info>
      <org_study_id>LHS0016</org_study_id>
      <nct_id>NCT06022367</nct_id>
    </id_info>
    <brief_title>Activation Technique in cVEMPs</brief_title>
    <acronym>ACTIVE</acronym>
    <official_title>An Investigation Into the Effect of the Head Raise and Head Turn Activation Techniques on Quality of Elicited Cervical Vestibular Evoked Myogenic Potentials (cVEMPs)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Liverpool University Hospitals NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Liverpool University Hospitals NHS Foundation Trust</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>
        This study will investigate two different techniques used for eliciting sternocleidomastoid&#xD;
        (SCM) muscle contraction. Sustained contraction of the SCM muscle is necessary for accurate&#xD;
        recording of cervical vestibular evoked myogenic potentials (cVEMPs). These responses are&#xD;
        used clinically to assess the function of structures within the vestibular system.&#xD;
  &#xD;
        The British Society of Audiology (BSA) guidelines recommend the head turn and head raise&#xD;
        techniques as effective methods for eliciting SCM contraction. However, they do not recommend&#xD;
        which technique to employ, leaving that to the discretion of the clinician. The purpose of&#xD;
        this study is to determine which activation technique to recommend in the local standard&#xD;
        operating procedure on cVEMP testing developed by the Audiology and Vestibular Function&#xD;
        Testing service based at the Royal Liverpool University Hospital.&#xD;
  &#xD;
        Healthy volunteers will be recruited to the study. The study will be conducted at the Royal&#xD;
        Liverpool University Hospital, Liverpool, UK.&#xD;
  &#xD;
        The participants will each be invited to attend one appointment in which they will undergo&#xD;
        cVEMP testing, performed using each activation technique in turn. After testing the&#xD;
        participants will be asked to complete a questionnaire in which they will comment on their&#xD;
        experience of performing each technique and assign each a tolerability rating.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 15, 2022</start_date>
    <completion_date type="Actual">February 24, 2023</completion_date>
    <primary_completion_date type="Actual">February 24, 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>Crossover Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>cVEMP signal quality</measure>
      <time_frame>During single 1.5 hour appointment</time_frame>
      <description>Ratio of cVEMP signal power to background noise power</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>cVEMP signal amplitude</measure>
      <time_frame>During single 1.5 hour appointment</time_frame>
      <description>P1-N1 amplitude measured from the P1 to N1 peaks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Activation technique tolerability rating</measure>
      <time_frame>During single 1.5 hour appointment</time_frame>
      <description>Participant reported tolerability will be scored on a four-point LIKERT scale ranging from 1 (highly intolerable) to 4 (highly tolerable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Activation technique tolerability subjective feedback</measure>
      <time_frame>During single 1.5 hour appointment</time_frame>
      <description>Participant reported concerns shared through a post-test questionnaire</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Activation Technique in cVEMP Testing</condition>
    <arm_group>
      <arm_group_label>Raise-Turn Sequence</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant performs cVEMP twice using the head raise activation technique followed by the head turn activation technique.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Turn-Raise Sequence</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant performs cVEMP twice using the head turn activation technique followed by the head raise activation technique.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Head Turn Activation Technique</intervention_name>
      <description>Participant sat upright with head turned to the side through 45 degrees. They are presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.</description>
      <arm_group_label>Raise-Turn Sequence</arm_group_label>
      <arm_group_label>Turn-Raise Sequence</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Head Raise Activation Technique</intervention_name>
      <description>Participant assumes caloric test position (30 degrees from horizontal) with head raised. Participant is presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.</description>
      <arm_group_label>Raise-Turn Sequence</arm_group_label>
      <arm_group_label>Turn-Raise Sequence</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant is willing and able to give informed consent for participation in the&#xD;
               study.&#xD;
  &#xD;
            -  Able (in the Investigators opinion) and willing to comply with all study requirements.&#xD;
  &#xD;
            -  Male, female or non-binary, aged 18-60 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pain, sore areas, broken skin at the sites of contact with skin electrodes&#xD;
  &#xD;
            -  Devices, e.g. cochlear implants, which may cause electrical interference&#xD;
  &#xD;
          Exclusion criteria to cVEMP procedure :&#xD;
  &#xD;
            -  Conductive hearing loss of middle ear origin&#xD;
  &#xD;
            -  Sensitivity to sounds e.g. tinnitus, hyperacusis etc.&#xD;
  &#xD;
            -  Cervical spine problems&#xD;
  &#xD;
          Exclusion criteria to tympanometry procedure :&#xD;
  &#xD;
            -  Occlusion of the external auditory canal&#xD;
  &#xD;
            -  Otorrhoea&#xD;
  &#xD;
            -  Otalgia&#xD;
  &#xD;
            -  Excessive wax&#xD;
  &#xD;
            -  Within two months of ear surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Liverpool University Hospitals NHS Foundation Trust</name>
        <address>
          <city>Liverpool</city>
          <zip>L7 8XP</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2022</verification_date>
    <study_first_submitted>November 23, 2022</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06022367
  org study id: LHS0016
  nct id: NCT06022367
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will investigate two different techniques used for eliciting sternocleidomastoid
        (SCM) muscle contraction. Sustained contraction of the SCM muscle is necessary for accurate
        recording of cervical vestibular evoked myogenic potentials (cVEMPs). These responses are
        used clinically to assess the function of structures within the vestibular system.
  
        The British Society of Audiology (BSA) guidelines recommend the head turn and head raise
        techniques as effective methods for eliciting SCM contraction. However, they do not recommend
        which technique to employ, leaving that to the discretion of the clinician. The purpose of
        this study is to determine which activation technique to recommend in the local standard
        operating procedure on cVEMP testing developed by the Audiology and Vestibular Function
        Testing service based at the Royal Liverpool University Hospital.
  
        Healthy volunteers will be recruited to the study. The study will be conducted at the Royal
        Liverpool University Hospital, Liverpool, UK.
  
        The participants will each be invited to attend one appointment in which they will undergo
        cVEMP testing, performed using each activation technique in turn. After testing the
        participants will be asked to complete a questionnaire in which they will comment on their
        experience of performing each technique and assign each a tolerability rating.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: cVEMP signal quality
  time frame: During single 1.5 hour appointment
  description: Ratio of cVEMP signal power to background noise power
  measure: cVEMP signal amplitude
  time frame: During single 1.5 hour appointment
  description: P1-N1 amplitude measured from the P1 to N1 peaks
  measure: Activation technique tolerability rating
  time frame: During single 1.5 hour appointment
  description: Participant reported tolerability will be scored on a four-point LIKERT scale ranging from 1 (highly intolerable) to 4 (highly tolerable)
  measure: Activation technique tolerability subjective feedback
  time frame: During single 1.5 hour appointment
  description: Participant reported concerns shared through a post-test questionnaire
  arm group label: Raise-Turn Sequence
  arm group type: Experimental
  description: Participant performs cVEMP twice using the head raise activation technique followed by the head turn activation technique.
  arm group label: Turn-Raise Sequence
  arm group type: Experimental
  description: Participant performs cVEMP twice using the head turn activation technique followed by the head raise activation technique.
  intervention type: Diagnostic Test
  intervention name: Head Turn Activation Technique
  description: Participant sat upright with head turned to the side through 45 degrees. They are presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.
  arm group label: Raise-Turn Sequence
  arm group label: Turn-Raise Sequence
  intervention type: Diagnostic Test
  intervention name: Head Raise Activation Technique
  description: Participant assumes caloric test position (30 degrees from horizontal) with head raised. Participant is presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.
  arm group label: Raise-Turn Sequence
  arm group label: Turn-Raise Sequence
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United Kingdom
  responsible party type: Sponsor