<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/NCT03288753</url>
  </required_header>
  <id_info>
    <org_study_id>PIC_14</org_study_id>
    <nct_id>NCT03288753</nct_id>
  </id_info>
  <brief_title>Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors</brief_title>
  <official_title>Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech 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>
      The present study aims to evaluate patient satisfaction and audiological performance with&#xD;
      their current cochlear implant speech processor, the Neuro 1, and to compare it with the&#xD;
      satisfaction and performance obtained with the new speech processor, the Neuro 2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound&#xD;
      sensorineural hearing loss. Oticon Medical recently developed a new cochlear implant system,&#xD;
      including a new implantable internal part (Neuro Zti) and a new speech processor (Neuro 1).&#xD;
      This new speech processor automatically detects and adapts to the sound environment,&#xD;
      increasing the ease of listening in all situations. A second version of this speech processor&#xD;
      has very recently been developed, called the Neuro 2. The Neuro 1 and 2 share the same signal&#xD;
      processing characteristics and the &quot;sound&quot; delivered to the patient is similar. However, the&#xD;
      Neuro 2 offers better ergonomics (smaller size and weight, rechargeable batteries…). Some&#xD;
      improvements available on the Neuro 2 may be particularly interesting for children.&#xD;
&#xD;
      The aim of the present study is twofold: 1. Compare the satisfaction of adult and pediatric&#xD;
      users for the speech processor Neuro 1 with their satisfaction for the Neuro 2, and 2. Show&#xD;
      that audiological outcomes are at least as good for the Neuro 2 than for the Neuro 1.&#xD;
&#xD;
      The participants come at the hospital for three visits. The Neuro 1 is evaluated during the&#xD;
      first visit (V1). Evaluation of the Neuro 2 takes place during the second (V2, 15 days after&#xD;
      V1) and the third (V3, 3 months after V2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">January 11, 2019</completion_date>
  <primary_completion_date type="Actual">January 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction questionnaire</measure>
    <time_frame>15 minutes</time_frame>
    <description>The listener has to rate his appreciation of the Neuro 1 and Neuro 2 device and the sound quality on 7 points scale. The outcome measure corresponds to averaged score. The questionnaire has been developed by Oticon Medical to investigate satisfaction patient for their current and future speech processors. This questionnaire is not validated in the literature.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Speech comprehension in quiet</measure>
    <time_frame>15 mins</time_frame>
    <description>The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech comprehension in Noise</measure>
    <time_frame>15 mins</time_frame>
    <description>The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>French Quick Sin</measure>
    <time_frame>5 mins</time_frame>
    <description>This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Sensorineural Hearing Loss</condition>
  <condition>Cochlear Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Adults and children above 14 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Visit 1:&#xD;
Satisfaction questionnaire on Neuro 1 Speech intelligibility in quiet on Neuro 1 Speech intelligibility in noise on Neuro 1 VRB (Vocale Rapide dans le Bruit) on Neuro 1&#xD;
Visit 2 (15 days after V1):&#xD;
Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2&#xD;
Visit 3 (3 months after V2):&#xD;
Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>children up to 14 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Visit 1 Satisfaction questionnaire on Neuro 1&#xD;
Visit 2 (15 days after V1):&#xD;
Satisfaction questionnaire on Neuro 2&#xD;
Visit 3 (3 months after V2):&#xD;
Satisfaction questionnaire on Neuro 2&#xD;
The questionnaires have to be filled in by the parents. The child can participate in the completion of the questionnaire if he is willing and understands the questions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Satisfaction questionnaire</intervention_name>
    <description>Participants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor.</description>
    <arm_group_label>Adults and children above 14 years old</arm_group_label>
    <arm_group_label>children up to 14 years old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Speech intelligibility in quiet</intervention_name>
    <description>The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.</description>
    <arm_group_label>Adults and children above 14 years old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Speech intelligibility in noise</intervention_name>
    <description>The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. The noise corresponds to a cocktail party presented at +10 dB SNR (Speech on Noise Ratio). At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.</description>
    <arm_group_label>Adults and children above 14 years old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VRB (Vocale Rapide dans le Bruit)</intervention_name>
    <description>Speech intelligibility in noise measured with the test VRB (Vocale Rapide dans le Bruit, French version of the Quick Sin). This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB. 3 lists are presented. Speech signals are presented at 60 dB SPL.</description>
    <arm_group_label>Adults and children above 14 years old</arm_group_label>
    <other_name>french Quick SIN</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  Native French speaker or fluent French speaker&#xD;
&#xD;
          -  Patient already fitted with one or two speech processor Neuro 1 for at least 5 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vulnerable patients, at the exception of children (pregnant women, persons under&#xD;
             guardianship)&#xD;
&#xD;
          -  No Social security affiliation&#xD;
&#xD;
          -  non-compliant patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christophe Vincent, MD, PROF</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Roger Salengro CHRU de Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Roger Salengro</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Nancy Hôpital central</name>
      <address>
        <city>Nancy</city>
        <zip>54035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes Hôtel-Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nice - Institut Universitaire de la Face et du Cou</name>
      <address>
        <city>Nice</city>
        <zip>06103</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Pédiatriques de Nice CHU-Lenval</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié Salpêtrière - APHP</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker-Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cochlear implant</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/NCT03288753
org study id: PIC_14
nct id: NCT03288753
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study aims to evaluate patient satisfaction and audiological performance with
      their current cochlear implant speech processor, the Neuro 1, and to compare it with the
      satisfaction and performance obtained with the new speech processor, the Neuro 2.
Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound
      sensorineural hearing loss. Oticon Medical recently developed a new cochlear implant system,
      including a new implantable internal part (Neuro Zti) and a new speech processor (Neuro 1).
      This new speech processor automatically detects and adapts to the sound environment,
      increasing the ease of listening in all situations. A second version of this speech processor
      has very recently been developed, called the Neuro 2. The Neuro 1 and 2 share the same signal
      processing characteristics and the "sound" delivered to the patient is similar. However, the
      Neuro 2 offers better ergonomics (smaller size and weight, rechargeable batteries…). Some
      improvements available on the Neuro 2 may be particularly interesting for children.

      The aim of the present study is twofold: 1. Compare the satisfaction of adult and pediatric
      users for the speech processor Neuro 1 with their satisfaction for the Neuro 2, and 2. Show
      that audiological outcomes are at least as good for the Neuro 2 than for the Neuro 1.

      The participants come at the hospital for three visits. The Neuro 1 is evaluated during the
      first visit (V1). Evaluation of the Neuro 2 takes place during the second (V2, 15 days after
      V1) and the third (V3, 3 months after V2).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Satisfaction questionnaire
time frame: 15 minutes
description: The listener has to rate his appreciation of the Neuro 1 and Neuro 2 device and the sound quality on 7 points scale. The outcome measure corresponds to averaged score. The questionnaire has been developed by Oticon Medical to investigate satisfaction patient for their current and future speech processors. This questionnaire is not validated in the literature.
measure: Speech comprehension in quiet
time frame: 15 mins
description: The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.
measure: Speech comprehension in Noise
time frame: 15 mins
description: The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.
measure: French Quick Sin
time frame: 5 mins
description: This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB.
arm group label: Adults and children above 14 years old
arm group type: Experimental
description: Visit 1:
Satisfaction questionnaire on Neuro 1 Speech intelligibility in quiet on Neuro 1 Speech intelligibility in noise on Neuro 1 VRB (Vocale Rapide dans le Bruit) on Neuro 1
Visit 2 (15 days after V1):
Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2
Visit 3 (3 months after V2):
Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2
arm group label: children up to 14 years old
arm group type: Experimental
description: Visit 1 Satisfaction questionnaire on Neuro 1
Visit 2 (15 days after V1):
Satisfaction questionnaire on Neuro 2
Visit 3 (3 months after V2):
Satisfaction questionnaire on Neuro 2
The questionnaires have to be filled in by the parents. The child can participate in the completion of the questionnaire if he is willing and understands the questions.
intervention type: Other
intervention name: Satisfaction questionnaire
description: Participants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor.
arm group label: Adults and children above 14 years old
arm group label: children up to 14 years old
intervention type: Behavioral
intervention name: Speech intelligibility in quiet
description: The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
arm group label: Adults and children above 14 years old
intervention type: Behavioral
intervention name: Speech intelligibility in noise
description: The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. The noise corresponds to a cocktail party presented at +10 dB SNR (Speech on Noise Ratio). At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
arm group label: Adults and children above 14 years old
intervention type: Behavioral
intervention name: VRB (Vocale Rapide dans le Bruit)
description: Speech intelligibility in noise measured with the test VRB (Vocale Rapide dans le Bruit, French version of the Quick Sin). This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB. 3 lists are presented. Speech signals are presented at 60 dB SPL.
arm group label: Adults and children above 14 years old
other name: french Quick SIN
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Christophe Vincent, MD, PROF
role: Principal Investigator
affiliation: Hôpital Roger Salengro CHRU de Lille
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Sensorineural
sharing ipd: No