<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/NCT02239263</url>
  </required_header>
  <id_info>
    <org_study_id>CAM5555</org_study_id>
    <nct_id>NCT02239263</nct_id>
  </id_info>
  <brief_title>N6 Input Processing in Traditional CI Recipients</brief_title>
  <official_title>Investigation of Nucleus 6 Sound Processor Input Processing in Cochlear Implant Recipients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cochlear</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cochlear</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the enhanced signal processing features of the&#xD;
      Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the&#xD;
      Nucleus 5 Sound Processor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction</measure>
    <time_frame>Visit 2, 1 month after baseline testing</time_frame>
    <description>Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endpoint 2: Evaluation of SCAN</measure>
    <time_frame>Visit 2, 1 month after baseline testing</time_frame>
    <description>Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>N6 Input Processing Features</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nucleus 6 Sound Processor</intervention_name>
    <arm_group_label>N6 Input Processing Features</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater than 12 years&#xD;
&#xD;
          -  Unilateral cochlear implant recipient (CI24RE, CI500, CI422)&#xD;
&#xD;
          -  Minimum of 3 months experience with the N5 sound processor&#xD;
&#xD;
          -  Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB&#xD;
             SNR or better&#xD;
&#xD;
          -  Native English speaker&#xD;
&#xD;
          -  Willingness to participate in and comply with all requirements of the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unrealistic expectations&#xD;
&#xD;
          -  Unwillingness to comply with investigational requirements of the protocol&#xD;
&#xD;
          -  Additional handicaps that would prevent or restrict participation in the evaluations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rocky Mountain Ear Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Hearing and Balance</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Ear Research Foundation</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>November 3, 2020</results_first_submitted>
  <results_first_submitted_qc>February 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 26, 2021</results_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>As of the date of database closure, 34 of the 40 enrolled subjects completed Visit Two (endpoint testing).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>N6 Input Processing Features - SNR-NR &amp; SCAN</title>
          <description>Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) and SCAN (endpoint 2)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>N6 Input Processing Features - SNR-NR &amp; SCAN</title>
          <description>Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1) and SCAN (endpoint 2)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47" spread="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction</title>
        <description>Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.</description>
        <time_frame>Visit 2, 1 month after baseline testing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>N6 Input Processing Features - SNR</title>
            <description>Endpoint 1: Assessment of Nucleus 6 sound processing feature SNR-NR</description>
          </group>
        </group_list>
        <measure>
          <title>Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction</title>
          <description>Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.</description>
          <units>difference in percent correct scores</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.9" lower_limit="-9.6" upper_limit="-2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Endpoint 2: Evaluation of SCAN</title>
        <description>Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.</description>
        <time_frame>Visit 2, 1 month after baseline testing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>N6 Input Processing Features</title>
            <description>Endpoint 1: Assessment of Nucleus 6 sound processing feature SCAN</description>
          </group>
        </group_list>
        <measure>
          <title>Endpoint 2: Evaluation of SCAN</title>
          <description>Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.</description>
          <units>difference in percent correct scores</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.9" lower_limit="-33" upper_limit="-20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>N6 Input Processing Features - SNR-NR</title>
          <description>Testing of the Nucleus 6 sound processing Signal to Noise Ratio - Noise Reduction (endpoint 1)</description>
        </group>
        <group group_id="E2">
          <title>N6 Input Processing Features - SCAN</title>
          <description>Testing of the Nucleus 6 sound processing SCAN (endpoint 2)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lori O'Neill Director of Research</name_or_title>
      <organization>cochlear</organization>
      <phone>8005235798</phone>
      <email>loneill@cochlear.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02239263
org study id: CAM5555
nct id: NCT02239263
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the enhanced signal processing features of the
      Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the
      Nucleus 5 Sound Processor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction
time frame: Visit 2, 1 month after baseline testing
description: Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
measure: Endpoint 2: Evaluation of SCAN
time frame: Visit 2, 1 month after baseline testing
description: Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
arm group label: N6 Input Processing Features
arm group type: Experimental
intervention type: Device
intervention name: Nucleus 6 Sound Processor
arm group label: N6 Input Processing Features
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hearing Loss
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 