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/NCT06021132</url>
    </required_header>
    <id_info>
      <org_study_id>RN-86132</org_study_id>
      <nct_id>NCT06021132</nct_id>
    </id_info>
    <brief_title>Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation</brief_title>
    <official_title>Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation</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>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will follow a cohort of CI-candidates becoming CI-user, till two years&#xD;
        postoperative. A through-out assessment of both their audiological and vestibular status will&#xD;
        be carried out at multiple fixed timepoints over 2 years, evaluating both subjective&#xD;
        (patients reported) and objective outcomes over time. For the audiological part of the study&#xD;
        both pure-tone and speech audiometry results will be held against the patient perceived&#xD;
        benefit of the treatment as assessed by the questionnaires NCIQ and SSQ-12. The vestibular&#xD;
        part of the study will evaluate the function of the SCCs and the sacculus. This is will be&#xD;
        put in concert with functional tests of the vestibular system, and the patient perceived&#xD;
        outcome measure DHI. Correlations between vestibular and audiological performances will be&#xD;
        examined. A collection of specific hypotheses will be tested by predefined statistical&#xD;
        methods.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2022</start_date>
    <completion_date type="Anticipated">February 28, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Anticipated increase in speech audiometric performances</measure>
      <time_frame>+24 months from last inclusion. Expected to be complete in juli 2025.</time_frame>
      <description>The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anticipated increase in patient reported outcome measures</measure>
      <time_frame>+24 months from last inclusion. Expected to be complete in juli 2025.</time_frame>
      <description>The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months</description>
    </primary_outcome>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Hearing Loss, Sensorineural</condition>
    <condition>Hearing Loss, Bilateral</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>cochlear implant</intervention_name>
      <description>Insertion of a electrode into the cochlear with the aim of providing deaf and severe hearing handicapped with the ability to hear speech.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult CI-candidates are to be included from our tertiary referral centre at the&#xD;
          Audiological Department at Aalborg University Hospital, Aalborg, Denmark.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults (At or above 18 years of age and capable of giving an informed consent)&#xD;
  &#xD;
            -  Cochlear implant candidacy&#xD;
  &#xD;
            -  Profound bilateral post-lingual hearing loss&#xD;
  &#xD;
            -  Proficiency in Danish&#xD;
  &#xD;
            -  Expected ability to participate on both all pre- and postoperative examinations&#xD;
  &#xD;
            -  No previous CI experiences&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Later abandonment of CI candidacy&#xD;
  &#xD;
            -  Blindness or visual handicap compromising eye movement evaluation&#xD;
  &#xD;
            -  Distinct neck mobility handicap hindering either vHIT- or cVEMP examination&#xD;
  &#xD;
            -  Patient reluctance, such as consistent no-show or cancellations of appointments&#xD;
  &#xD;
            -  CI-surgery before preoperative evaluation could be obtained&#xD;
  &#xD;
            -  Simultaneous bilateral cochlea implantation.&#xD;
  &#xD;
            -  Sequential CI within the follow-up period&#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>Jonas B Kjlærsgaard, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>ENT department, Aalborg University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Michael L Gaihede, PhD, MD</last_name>
      <role>Study Director</role>
      <affiliation>ENT department, Aalborg University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jonas B Kjærsgaard, MD</last_name>
      <phone>+45 96762735</phone>
      <email>jonas.kjaersgaard@rn.dk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Balance &amp; Dizziness Centre, Department of Otolaryngology, Head &amp; Neck Surgery and Audiology, Aalborg University Hospital</name>
        <address>
          <city>Aalborg</city>
          <zip>9000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jonas B Kjærsgaard, MD</last_name>
      </contact>
      <contact_backup>
        <last_name>Michael L Gaihede, PhD, MD</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aalborg University Hospital</investigator_affiliation>
      <investigator_full_name>Jonas Bruun Kjærsgaard</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>Cochlear implant</keyword>
    <keyword>Residual hearing</keyword>
    <keyword>Hearing preservation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hearing Loss</mesh_term>
      <mesh_term>Deafness</mesh_term>
      <mesh_term>Hearing Loss, Sensorineural</mesh_term>
      <mesh_term>Hearing Loss, Bilateral</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Full plan of analysis and raw data will be presented given there is still anonymity for the participants.</ipd_description>
    </patient_data>
    <!-- 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/NCT06021132
  org study id: RN-86132
  nct id: NCT06021132
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The study will follow a cohort of CI-candidates becoming CI-user, till two years
        postoperative. A through-out assessment of both their audiological and vestibular status will
        be carried out at multiple fixed timepoints over 2 years, evaluating both subjective
        (patients reported) and objective outcomes over time. For the audiological part of the study
        both pure-tone and speech audiometry results will be held against the patient perceived
        benefit of the treatment as assessed by the questionnaires NCIQ and SSQ-12. The vestibular
        part of the study will evaluate the function of the SCCs and the sacculus. This is will be
        put in concert with functional tests of the vestibular system, and the patient perceived
        outcome measure DHI. Correlations between vestibular and audiological performances will be
        examined. A collection of specific hypotheses will be tested by predefined statistical
        methods.
  observational model: Cohort
  time perspective: Prospective
  measure: Anticipated increase in speech audiometric performances
  time frame: +24 months from last inclusion. Expected to be complete in juli 2025.
  description: The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months
  measure: Anticipated increase in patient reported outcome measures
  time frame: +24 months from last inclusion. Expected to be complete in juli 2025.
  description: The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months
  intervention type: Device
  intervention name: cochlear implant
  description: Insertion of a electrode into the cochlear with the aim of providing deaf and severe hearing handicapped with the ability to hear speech.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jonas B Kjlærsgaard, MD
  role: Principal Investigator
  affiliation: ENT department, Aalborg University Hospital
  last name: Michael L Gaihede, PhD, MD
  role: Study Director
  affiliation: ENT department, Aalborg University Hospital
  last name: Jonas B Kjærsgaard, MD
  phone: +45 96762735
  email: jonas.kjaersgaard@rn.dk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Aalborg University Hospital
  investigator full name: Jonas Bruun Kjærsgaard
  investigator title: MD
  mesh term: Hearing Loss
  mesh term: Deafness
  mesh term: Hearing Loss, Sensorineural
  mesh term: Hearing Loss, Bilateral
  sharing ipd: Undecided
  ipd description: Full plan of analysis and raw data will be presented given there is still anonymity for the participants.