<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/NCT03026829</url>
  </required_header>
  <id_info>
    <org_study_id>CEL5684</org_study_id>
    <nct_id>NCT03026829</nct_id>
  </id_info>
  <brief_title>Sound Therapy for Tinnitus Relief in Cochlear Implant Users</brief_title>
  <official_title>&quot;Cochlear Active Relief From Tinnitus (CART) Sound Therapy&quot; for Tinnitus Relief in Nucleus® Cochlear Implant Users With Tinnitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cochlear</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cochlear</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>
      The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy&#xD;
      for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a&#xD;
      combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from&#xD;
      Tinnitus (CART) firmware.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Number of subjects could not be achieved due to slow recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">January 24, 2019</completion_date>
  <primary_completion_date type="Actual">January 24, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)</measure>
    <time_frame>week 0</time_frame>
    <description>Visual Analogue Scale (VAS) score on tinnitus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)</measure>
    <time_frame>week 2</time_frame>
    <description>Visual Analogue Scale (VAS) score on tinnitus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)</measure>
    <time_frame>week 7</time_frame>
    <description>Visual Analogue Scale (VAS) score on tinnitus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)</measure>
    <time_frame>week 0</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)</measure>
    <time_frame>week 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)</measure>
    <time_frame>week 7</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Tinnitus, Hearing Loss, Cochlear Implant Users</condition>
  <arm_group>
    <arm_group_label>CART sound therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CART sound therapy</intervention_name>
    <description>The study consists of two parts:&#xD;
Phase 1: laboratory evaluation of CART sound acceptability&#xD;
Phase 2: take home evaluation of CART sound therapy including baseline without CART</description>
    <arm_group_label>CART sound therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Self-reported tinnitus during standard Cochlear Implant (CI) activation for at least&#xD;
             one month&#xD;
&#xD;
          -  At least three months use of unilateral or bilateral Nucleus CI(s) driven by a CP900&#xD;
             Sound Processor. For bilateral use the most recently activated CI is used for at least&#xD;
             three months&#xD;
&#xD;
          -  Native speaker and fluency in the language used in the assessments (i.e. Dutch)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Additional handicaps that would prevent participation in evaluations&#xD;
&#xD;
          -  History of psychiatric disorders or depression (on investigator's opinion)&#xD;
&#xD;
          -  Unrealistic expectations as identified by the clinician on the part of the subject,&#xD;
             regarding the possible benefits, risks and limitations that are inherent to the study&#xD;
&#xD;
          -  Pulsatile or diagnosed objective / middle ear tinnitus&#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>Bart Volckaerts, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Cochlear</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Otorhinolaryngology, Maastricht University Medical Centre</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Otorhinolaryngology, Head and Neck Surgery</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Tyler RS, Keiner AJ, Walker K, Deshpande AK, Witt S, Killian M, Ji H, Patrick J, Dillier N, van Dijk P, Lai WK, Hansen MR, Gantz B. A Series of Case Studies of Tinnitus Suppression With Mixed Background Stimuli in a Cochlear Implant. Am J Audiol. 2015 Sep;24(3):398-410. doi: 10.1044/2015_AJA-15-0005.</citation>
    <PMID>26001407</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sound therapy</keyword>
  <keyword>Tinnitus relief</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Tinnitus</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
  </condition_browse>
  <!-- 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/NCT03026829
org study id: CEL5684
nct id: NCT03026829
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy
      for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a
      combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from
      Tinnitus (CART) firmware.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
time frame: week 0
description: Visual Analogue Scale (VAS) score on tinnitus
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
time frame: week 2
description: Visual Analogue Scale (VAS) score on tinnitus
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
time frame: week 7
description: Visual Analogue Scale (VAS) score on tinnitus
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
time frame: week 0
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
time frame: week 2
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
time frame: week 7
arm group label: CART sound therapy
arm group type: Experimental
intervention type: Device
intervention name: CART sound therapy
description: The study consists of two parts:
Phase 1: laboratory evaluation of CART sound acceptability
Phase 2: take home evaluation of CART sound therapy including baseline without CART
arm group label: CART sound therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bart Volckaerts, PhD
role: Study Chair
affiliation: Cochlear
facility: 
facility: 
country: Netherlands
citation: Tyler RS, Keiner AJ, Walker K, Deshpande AK, Witt S, Killian M, Ji H, Patrick J, Dillier N, van Dijk P, Lai WK, Hansen MR, Gantz B. A Series of Case Studies of Tinnitus Suppression With Mixed Background Stimuli in a Cochlear Implant. Am J Audiol. 2015 Sep;24(3):398-410. doi: 10.1044/2015_AJA-15-0005.
PMID: 26001407
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Tinnitus
mesh term: Hearing Loss, Sensorineural