<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/NCT03256097</url>
  </required_header>
  <id_info>
    <org_study_id>PIC_12</org_study_id>
    <nct_id>NCT03256097</nct_id>
  </id_info>
  <brief_title>Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System</brief_title>
  <official_title>Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System</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>Yes</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>
      The study aims to compare two different cochlear implant sound processing strategies. All the&#xD;
      participants will start off with a sound processing strategy called the XDP (extended&#xD;
      performance). At the 3 month stage, half of the participants would randomly be selected and&#xD;
      offered a sound processing strategy called the Voice Guard. Following that, the sound&#xD;
      processing strategies will be altered and evaluated every 3 months at the 6th, 9th and 12th&#xD;
      month of cochlear implant use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Voice Guard and XDP are two different cochlear implant sound processing strategies. The Voice&#xD;
      Guard sound coding strategy is adaptive in nature and can alter the output from the cochlear&#xD;
      implant based on the levels of the listening environment. Hence, it can adapt to soft, medium&#xD;
      or conversational and loud speech levels.The XDP on the other hand is not adaptive and cannot&#xD;
      alter the cochlear implant output according to the levels of the listening environment.&#xD;
&#xD;
      In the study we are hypothesising that the Voice Guard sound processing strategy will perform&#xD;
      better than the XDP strategy for soft (40 dB SPL) and loud (85 dB SPL) speech input levels.&#xD;
      Speech perception scores will be recorded at 40, 65 and 85 dB SPL and a cross over study&#xD;
      design has been adopted.&#xD;
&#xD;
      In addition, the efficacy of a cochlear implant sound reduction technique called Voice Track&#xD;
      will also be evaluated. The Voice Track is designed to reduce the adverse effect of&#xD;
      background noise on cochlear implant speech perception.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2018</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</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>
    <intervention_model_description>A-B-A vs B-A-B</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speech perception scores in quite and in noise</measure>
    <time_frame>12 months</time_frame>
    <description>Speech perception with each intervention will be measured and a score between 0 to 100% will be obtained</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome measure</measure>
    <time_frame>12 months</time_frame>
    <description>Glasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Cochlear Implantation</condition>
  <arm_group>
    <arm_group_label>XDP - VG - XDP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>order of testing: XDP - VG - XDP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VG - XDP - VG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>order of testing: VG - XDP - VG</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XDP sound processing strategy - Period 0</intervention_name>
    <description>XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.</description>
    <arm_group_label>VG - XDP - VG</arm_group_label>
    <arm_group_label>XDP - VG - XDP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XDP sound processing strategy - Period 1</intervention_name>
    <description>XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.</description>
    <arm_group_label>XDP - VG - XDP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VG sound processing strategy - Period 1</intervention_name>
    <description>Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.</description>
    <arm_group_label>VG - XDP - VG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XDP sound processing strategy - Period 2</intervention_name>
    <description>XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.</description>
    <arm_group_label>VG - XDP - VG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VG sound processing strategy - Period 2</intervention_name>
    <description>Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend</description>
    <arm_group_label>XDP - VG - XDP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XDP sound processing strategy - Period 3</intervention_name>
    <description>XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.</description>
    <arm_group_label>XDP - VG - XDP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VG sound processing strategy - Period 3</intervention_name>
    <description>Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend</description>
    <arm_group_label>VG - XDP - VG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Voice Track</intervention_name>
    <description>Voice Track is a cochlear implant noise cancellation system which is designed to reduce the adverse effect of background noise on speech perception through cochlear implants</description>
    <arm_group_label>VG - XDP - VG</arm_group_label>
    <arm_group_label>XDP - VG - XDP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals aged between 18 and 70 years&#xD;
&#xD;
          -  Individuals with post-lingual hearing loss&#xD;
&#xD;
          -  Individuals with no language and speech production disorders&#xD;
&#xD;
          -  Individuals who are native speakers of English&#xD;
&#xD;
          -  Individuals meeting NICE candidacy criteria for CI surgery&#xD;
&#xD;
          -  Individuals undergoing primary unilateral cochlear implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical conditions contraindicating CI surgery&#xD;
&#xD;
          -  Individuals with anatomical anomalies of the auditory system&#xD;
&#xD;
          -  Individuals with additional mental health issues or and/or cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Tysome</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Head and Neck Surgeon, Addenbrookes Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Addenbrooke's Hospital, Cambridge University Hospitals Trust</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sound processing strategy</keyword>
  <!-- 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/NCT03256097
org study id: PIC_12
nct id: NCT03256097
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study aims to compare two different cochlear implant sound processing strategies. All the
      participants will start off with a sound processing strategy called the XDP (extended
      performance). At the 3 month stage, half of the participants would randomly be selected and
      offered a sound processing strategy called the Voice Guard. Following that, the sound
      processing strategies will be altered and evaluated every 3 months at the 6th, 9th and 12th
      month of cochlear implant use.
Voice Guard and XDP are two different cochlear implant sound processing strategies. The Voice
      Guard sound coding strategy is adaptive in nature and can alter the output from the cochlear
      implant based on the levels of the listening environment. Hence, it can adapt to soft, medium
      or conversational and loud speech levels.The XDP on the other hand is not adaptive and cannot
      alter the cochlear implant output according to the levels of the listening environment.

      In the study we are hypothesising that the Voice Guard sound processing strategy will perform
      better than the XDP strategy for soft (40 dB SPL) and loud (85 dB SPL) speech input levels.
      Speech perception scores will be recorded at 40, 65 and 85 dB SPL and a cross over study
      design has been adopted.

      In addition, the efficacy of a cochlear implant sound reduction technique called Voice Track
      will also be evaluated. The Voice Track is designed to reduce the adverse effect of
      background noise on cochlear implant speech perception.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A-B-A vs B-A-B
primary purpose: Treatment
masking: Single (Participant)
measure: Speech perception scores in quite and in noise
time frame: 12 months
description: Speech perception with each intervention will be measured and a score between 0 to 100% will be obtained
measure: Patient reported outcome measure
time frame: 12 months
description: Glasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention
arm group label: XDP - VG - XDP
arm group type: Experimental
description: order of testing: XDP - VG - XDP
arm group label: VG - XDP - VG
arm group type: Experimental
description: order of testing: VG - XDP - VG
intervention type: Device
intervention name: XDP sound processing strategy - Period 0
description: XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
arm group label: VG - XDP - VG
arm group label: XDP - VG - XDP
intervention type: Device
intervention name: XDP sound processing strategy - Period 1
description: XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
arm group label: XDP - VG - XDP
intervention type: Device
intervention name: VG sound processing strategy - Period 1
description: Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
arm group label: VG - XDP - VG
intervention type: Device
intervention name: XDP sound processing strategy - Period 2
description: XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
arm group label: VG - XDP - VG
intervention type: Device
intervention name: VG sound processing strategy - Period 2
description: Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend
arm group label: XDP - VG - XDP
intervention type: Device
intervention name: XDP sound processing strategy - Period 3
description: XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
arm group label: XDP - VG - XDP
intervention type: Device
intervention name: VG sound processing strategy - Period 3
description: Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend
arm group label: VG - XDP - VG
intervention type: Device
intervention name: Voice Track
description: Voice Track is a cochlear implant noise cancellation system which is designed to reduce the adverse effect of background noise on speech perception through cochlear implants
arm group label: VG - XDP - VG
arm group label: XDP - VG - XDP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: James Tysome
role: Principal Investigator
affiliation: Consultant Head and Neck Surgeon, Addenbrookes Hospital
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor