<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/NCT02984748</url>
  </required_header>
  <id_info>
    <org_study_id>CLTD 5565</org_study_id>
    <nct_id>NCT02984748</nct_id>
  </id_info>
  <brief_title>Outcome Prediction in Cochlear Implant Recipients</brief_title>
  <official_title>Prediction of Outcomes in Adult Cochlear Implant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hearing Cooperative Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cochlear</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Attune Hearing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sydney Cochlear Implant Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hearing Cooperative Research Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ability to predict post-operative outcomes after implantation is important for a number&#xD;
      of reasons, including being able to advise candidates of appropriate expectations using&#xD;
      evidence based guidance. The approved study involves investigation of the ability to predict&#xD;
      outcomes in the implanted ear alone and in the best-aided binaural listening conditions,&#xD;
      examining a number of measured factors both pre-, peri- and post-operatively. The study&#xD;
      incorporates a range of functional outcome measures through questionnaires to ascertain&#xD;
      social, functional and demographic factors that may be predictive of outcomes. Questionnaires&#xD;
      are also administered to determine the degree of benefit obtained after implantation for each&#xD;
      individual, since this forms a key component of providing pre-operative counselling to&#xD;
      candidates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2014</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">March 2019</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>Speech recognition in quiet</measure>
    <time_frame>Testing over 12 months</time_frame>
    <description>Speech recognition scores in quiet</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech recognition in noise</measure>
    <time_frame>Testing over 12 months</time_frame>
    <description>Speech recognition scores in noise</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">267</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Cochlear Implant Recipients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cochlear implant</intervention_name>
    <arm_group_label>Cochlear Implant Recipients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Cochlear Implant Recipients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical suitability for first side implantation, i.e. not undergoing assessment for&#xD;
             second side cochlear implant surgery&#xD;
&#xD;
          2. Willing and able to attend the study visits&#xD;
&#xD;
          3. Able to provide informed consent for participation in the study, with an understanding&#xD;
             of the requirements, risks and benefits of participation in the investigation&#xD;
&#xD;
          4. Able to read and understand study documents and follow investigator instructions&#xD;
&#xD;
          5. Able to understand and follow study personnel instructions during audiological&#xD;
             measurements&#xD;
&#xD;
          6. Native speaker in the language used to assess clinical speech perception performance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Unrealistic expectations on the part of the subject regarding the possible benefits,&#xD;
        risks, and limitations that are inherent to enrolment in the clinical investigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The HEARing CRC</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>July 2, 2021</last_update_submitted>
  <last_update_submitted_qc>July 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cochlear implants</keyword>
  <keyword>hearing loss</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>
  </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/NCT02984748
org study id: CLTD 5565
nct id: NCT02984748
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The ability to predict post-operative outcomes after implantation is important for a number
      of reasons, including being able to advise candidates of appropriate expectations using
      evidence based guidance. The approved study involves investigation of the ability to predict
      outcomes in the implanted ear alone and in the best-aided binaural listening conditions,
      examining a number of measured factors both pre-, peri- and post-operatively. The study
      incorporates a range of functional outcome measures through questionnaires to ascertain
      social, functional and demographic factors that may be predictive of outcomes. Questionnaires
      are also administered to determine the degree of benefit obtained after implantation for each
      individual, since this forms a key component of providing pre-operative counselling to
      candidates.
observational model: Cohort
time perspective: Prospective
measure: Speech recognition in quiet
time frame: Testing over 12 months
description: Speech recognition scores in quiet
measure: Speech recognition in noise
time frame: Testing over 12 months
description: Speech recognition scores in noise
arm group label: Cochlear Implant Recipients
intervention type: Device
intervention name: Cochlear implant
arm group label: Cochlear Implant Recipients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
sharing ipd: No