<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/NCT03756337</url>
  </required_header>
  <id_info>
    <org_study_id>PIC-20</org_study_id>
    <nct_id>NCT03756337</nct_id>
  </id_info>
  <brief_title>Neuro 1 vs. Neuro 2 Sound Processors</brief_title>
  <official_title>Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oticon Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oticon Medical</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 evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in&#xD;
      adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other&#xD;
      half will be tested with Neuro 2 first and then Neuro 1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Neuro 1 processor represented a technological advancement over past models, particularly&#xD;
      in detecting the environment and automatically adjusting to the sound environment. A second&#xD;
      version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and&#xD;
      stimulation characteristics are similar, so speech comprehension levels are expected to be&#xD;
      equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric&#xD;
      performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">January 10, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>speech recognition in quiet</measure>
    <time_frame>Day 1</time_frame>
    <description>Hearing In Noise Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>speech recognition in noise</measure>
    <time_frame>Day 1</time_frame>
    <description>Hearing In Noise Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pure tone threshold</measure>
    <time_frame>Day 1</time_frame>
    <description>from 250Hz to 8kHz</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hearing Loss, Sensorineural</condition>
  <condition>Cochlear Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Neuro 2 Upgrade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neuro 1 Downgrade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuro 1 &amp; Neuro 2</intervention_name>
    <description>participant common fitting map used for tests</description>
    <arm_group_label>Neuro 2 Upgrade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuro 2 &amp; Neuro 1</intervention_name>
    <description>participant common fitting map used for tests</description>
    <arm_group_label>Neuro 1 Downgrade</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  primary implantation&#xD;
&#xD;
          -  subject having participated to previous Neuro 1 sound processor study in Canada&#xD;
&#xD;
          -  fluent in English, including reading and writing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychologically unsuitable&#xD;
&#xD;
          -  unrealistic expectations regarding possible benefits, risks, and limitations that are&#xD;
             inherent to the device&#xD;
&#xD;
          -  non compliant with all investigational requirements.&#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>David Peter Morris, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalhousie University, Halifax,NS, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nova Scotia Hearing and Speech centres</name>
      <address>
        <city>Halifax</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>October 13, 2021</last_update_submitted>
  <last_update_submitted_qc>October 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cochlear implant</keyword>
  <keyword>sound processor</keyword>
  <keyword>upgrade</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>
  </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/NCT03756337
org study id: PIC-20
nct id: NCT03756337
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in
      adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other
      half will be tested with Neuro 2 first and then Neuro 1.
The Neuro 1 processor represented a technological advancement over past models, particularly
      in detecting the environment and automatically adjusting to the sound environment. A second
      version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and
      stimulation characteristics are similar, so speech comprehension levels are expected to be
      equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric
      performance.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: speech recognition in quiet
time frame: Day 1
description: Hearing In Noise Test
measure: speech recognition in noise
time frame: Day 1
description: Hearing In Noise Test
measure: pure tone threshold
time frame: Day 1
description: from 250Hz to 8kHz
arm group label: Neuro 2 Upgrade
arm group type: Experimental
description: Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested.
arm group label: Neuro 1 Downgrade
arm group type: Experimental
description: Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested.
intervention type: Device
intervention name: Neuro 1 & Neuro 2
description: participant common fitting map used for tests
arm group label: Neuro 2 Upgrade
intervention type: Device
intervention name: Neuro 2 & Neuro 1
description: participant common fitting map used for tests
arm group label: Neuro 1 Downgrade
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Peter Morris, MD
role: Principal Investigator
affiliation: Dalhousie University, Halifax,NS, Canada
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Sensorineural
sharing ipd: No