xml: <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/NCT06040892</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL22_0893</org_study_id>
      <nct_id>NCT06040892</nct_id>
    </id_info>
    <brief_title>Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children</brief_title>
    <acronym>KidTrain</acronym>
    <official_title>Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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>
        In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in&#xD;
        children, leading to an improvement of their quality of life. However, spatial hearing skills&#xD;
        of bCI children remain limited, even for children with the best speech understanding&#xD;
        outcomes. Recent studies have brought new insights in spatial hearing by using virtual&#xD;
        reality to record spatial hearing performance in 3D and the impact of active listening (i.e.&#xD;
        free head exploration during sound emission): all bCI children showed spatial hearing&#xD;
        difficulties related to front-back confusions and distance perception, which partly resulted&#xD;
        from the reduction in auditory cues by the CI settings. However, bCI children notably&#xD;
        improved under conditions of active listening, suggesting that interaction with environment&#xD;
        could represent a rehabilitation entry strategy to help bCI users when faced with complex&#xD;
        auditory scenes in daily life.&#xD;
  &#xD;
        The ability to localize sounds in space (spatial hearing) and the ability to understand&#xD;
        speech in noise are both auditory skills essential in daily interactions with our physical&#xD;
        and social environment and, when deficient, limit the quality of life. However, there is no&#xD;
        specific rehabilitation program devoted to spatial hearing which could help children face&#xD;
        their daily difficulties in noisy environments. Even though technological advances are&#xD;
        crucial to improve the restoration of hearing functions, these improvements are also highly&#xD;
        dependent on rehabilitation strategies to train our auditory brain to face the restoration of&#xD;
        binaural processing or to decode the impoverished spectral information delivered by the CI.&#xD;
  &#xD;
        The investigators recently performed a pilot study in bCI adults who attended 8 training&#xD;
        sessions of spatial hearing, involving a sensorial and interactive immersive environment&#xD;
        (i.e. virtual reality with auditory and visual environment during an active listening task).&#xD;
        All participants benefitted of the training, in terms of spatial hearing performance, speech&#xD;
        understanding in noise, and quality of life. All early benefits were maintained 1 month after&#xD;
        the end of training.&#xD;
  &#xD;
        The investigators aim to propose a spatial hearing rehabilitation program (KidTrain) adapted&#xD;
        to bCI children from 8 to 17 years old, based on their previous pilot study on bCI adults.&#xD;
        Their tool makes it possible to propose rehabilitation programs adapted to the performance&#xD;
        and expectations of each child. This program will manipulate both the ambient sound with&#xD;
        varying background noise to simulate daily life environments (i.e. making auditory detection&#xD;
        more or less complex), and also manipulate virtual immersive environment (i.e. giving more or&#xD;
        less relevant visual cues related to real sound location). The KidTrain's effects will be&#xD;
        measured with different auditory tests performed in noisy environments. The investigators&#xD;
        will also include Normal Hearing (NH) children as age-matched control groups to perform the&#xD;
        auditory tests in noise. These NH groups will also bring new insights of spatial hearing&#xD;
        maturation in complex auditory environments. Based on our preliminary data in bCI adults,&#xD;
        this 'KidTrain program' should improve spatial hearing skills of bCI children, speech&#xD;
        comprehension in noise and quality of life in many daily situations.&#xD;
  &#xD;
        Virtual reality (VR) has recently proven its effectiveness in rehabilitation in many domains&#xD;
        and recent studies have shown that this technology has its place in the auditory evaluation&#xD;
        and adaptation of spatial hearing. This VR approach takes advantage of the control of&#xD;
        multisensory cues of our environment (audio and visual) during a spatial hearing task, and&#xD;
        allows the subject to interact with his environment according to his hearing abilities and&#xD;
        needs (i.e. active listening).&#xD;
  &#xD;
        Based on their previous study conducted in bCI and NH children and on their spatial training&#xD;
        study conducted with bCI adults, the investigators wish to respond to the growing need of&#xD;
        spatial hearing rehabilitation for bCI children. To achieve this goal, the investigators will&#xD;
        improve the spatial training program by adding different immersive environment in VR with&#xD;
        various background noise to simulate daily life environments. This approach will also be a&#xD;
        great opportunity to characterize the developmental stages of spatial hearing maturation in&#xD;
        NH children. Thus, this project will propose new axes of speech therapy on the Orthophonie &amp;&#xD;
        Surdité platform, combining spatial hearing and speech understanding in noise. This&#xD;
        innovative and adapted rehabilitation program will lead the speech therapist to propose more&#xD;
        adapted and effective rehabilitations for the daily life of deaf children.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">May 2027</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>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.</measure>
      <time_frame>Immediately after 4 training sessions - day 42</time_frame>
      <description>The effect of spatial rehabilitation will be defined as any change in auditory performance (SPHERE value), between the initial assessment and after 4 training sessions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.</measure>
      <time_frame>Immediately after 4 training sessions - day 42</time_frame>
      <description>The effect of spatial rehabilitation will be defined as any change in auditory performance (FRASIMAT value), between the initial assessment and after 4 training sessions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.</measure>
      <time_frame>Immediately after 4 training sessions - day 42</time_frame>
      <description>The effect of spatial rehabilitation will be defined as any change in auditory performance (KID-SSQ score), between the initial assessment and after 4 training sessions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate the compliance of bCI children with the rehabilitation protocol</measure>
      <time_frame>At the end of the study ( Visit 13 - day 98)</time_frame>
      <description>Number of training sessions attended by bCI patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the impact of a spatialized sensory index in rehabilitation.</measure>
      <time_frame>At the end of the study ( Visit 13 - day 98)</time_frame>
      <description>Measures obtained at the E2 assessment (SPHERE value) between the group of bCI children in group A and those in group B.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the impact of a spatialized sensory index in rehabilitation.</measure>
      <time_frame>At the end of the study ( Visit 13 - day 98)</time_frame>
      <description>Measures obtained at the E2 assessment (FRASIMAT value) between the group of bCI children in group A and those in group B.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the impact of a spatialized sensory index in rehabilitation.</measure>
      <time_frame>At the end of the study ( Visit 13 - day 98)</time_frame>
      <description>Measures obtained at the E2 assessment (KID-SSQ score) between the group of bCI children in group A and those in group B.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the effect in the very short/short and medium term of spatial hearing rehabilitation on the spatial sound localization performance of bIC children compared to NH children</measure>
      <time_frame>At evaluation visits Day 0, 42, 77 and 98</time_frame>
      <description>SPHERE confusion rates (front-back, up-down, near-far) for bCI children at E2, E3 and E4 and NH children at E0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the effect of very short-term, short-term and medium-term spatial hearing rehabilitation on the speech comprehension performance of bIC children compared to NH children.</measure>
      <time_frame>At evaluation visits Day 0, 42, 77 and 98</time_frame>
      <description>FRASIMAT noise intelligibility scores for bCI children in E2, E3 and E4 and those for NH children in E0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the effect of very short-term and short-term and medium-term spatial hearing rehabilitation on the quality of life performance of bIC children compared to NH children.</measure>
      <time_frame>At evaluation visits Day 0, 42, 77 and 98</time_frame>
      <description>KID-SSQ spatial hearing scores obtained by bCI children in E2, E3 and E4 and those obtained by NH children in E0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the absence of spontaneous changes in auditory performance.</measure>
      <time_frame>At day 0 and 7</time_frame>
      <description>SPHERE measure for the bCI and NH groups between the E0 and E1 assessments.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the absence of spontaneous changes in auditory performance.</measure>
      <time_frame>At day 0 and 7</time_frame>
      <description>FRASIMAT measure for the bCI and NH groups between the E0 and E1 assessments.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the absence of spontaneous changes in auditory performance.</measure>
      <time_frame>At day 0 and 7</time_frame>
      <description>KID SSQ measure for the bCI and NH groups between the E0 and E1 assessments.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Cochlear Implantation</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>bilateral cochlear implant children with rehabilitation including 8 sessions with a spatialized sensory index</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>bilateral cochlear implant children with rehabilitation including initially 4 sessions without spatialized sensory cue followed by 4 sessions with spatialized sensory cue</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Normal hearing volunteers</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Children without known hearing loss</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>SPHERE protocol : Spatial hearing performances test</intervention_name>
      <description>Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHERE protocol).</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_label>Normal hearing volunteers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>FRASIMAT Test : audiology test of speech in noise perception</intervention_name>
      <description>Intelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening.</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_label>Normal hearing volunteers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale</intervention_name>
      <description>The SSQ questionnaire is a clinical subjective scale that allows evaluating of hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten.</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_label>Normal hearing volunteers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>spatial hearing rehabilitation program</intervention_name>
      <description>The tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location).</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Child aged between 7 and 17 years&#xD;
  &#xD;
            -  Normal vision (including correction),&#xD;
  &#xD;
            -  Able to understand the experimental instructions,&#xD;
  &#xD;
            -  Parents or guardians informed of the study and having signed the consent form,&#xD;
  &#xD;
          Specific for NH:&#xD;
  &#xD;
            -  Normal tone audiometry (mean threshold ≤ 30 dB). Specific for bIC&#xD;
  &#xD;
            -  Minimum 2 years of binaural experience,&#xD;
  &#xD;
            -  Average speech recognition ≥ 80% with both cochlear implants&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Bilateral vestibular areflexia,&#xD;
  &#xD;
            -  Attention deficit disorder,&#xD;
  &#xD;
            -  Known neurological or psychiatric disorders,&#xD;
  &#xD;
            -  Oculomotor disorders,&#xD;
  &#xD;
            -  Parents not affiliated to a social security scheme or beneficiaries of a similar&#xD;
               scheme who sign the consent for the child's participation,&#xD;
  &#xD;
            -  Subject participating in other interventional research with an exclusion period still&#xD;
               ongoing at inclusion.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aurélie Coudert, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Hospices Civils de Lyon</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aurélie Coudert, MD</last_name>
      <phone>0427855506</phone>
      <phone_ext>+33</phone_ext>
      <email>aurelie.coudert2@chu-lyon.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Valérie GAVEAU, MCU</last_name>
      <phone>04 72 91 34 10</phone>
      <phone_ext>+33</phone_ext>
      <email>valerie.gaveau@inserm.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale Hôpital Edouard Herriot, Groupement Hospitalier Centre</name>
        <address>
          <city>Lyon</city>
          <zip>69437</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Eric TRUY, Pr</last_name>
        <phone>04 72 11 04 92</phone>
        <phone_ext>+33</phone_ext>
        <email>eric.truy@chu-lyon.fr</email>
      </contact>
      <contact_backup>
        <last_name>Aurélie Coudert, MD</last_name>
        <phone>0427855506</phone>
        <phone_ext>+33</phone_ext>
        <email>aurelie.coudert2@chu-lyon.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>Coudert A, Gaveau V, Gatel J, Verdelet G, Salemme R, Farne A, Pavani F, Truy E. Spatial Hearing Difficulties in Reaching Space in Bilateral Cochlear Implant Children Improve With Head Movements. Ear Hear. 2022 Jan/Feb;43(1):192-205. doi: 10.1097/AUD.0000000000001090.</citation>
      <PMID>34225320</PMID>
    </reference>
    <reference>
      <citation>Valzolgher C, Gatel J, Bouzaid S, Grenouillet S, Todeschini M, Verdelet G, Salemme R, Gaveau V, Truy E, Farne A, Pavani F. Reaching to Sounds Improves Spatial Hearing in Bilateral Cochlear Implant Users. Ear Hear. 2023 Jan-Feb 01;44(1):189-198. doi: 10.1097/AUD.0000000000001267. Epub 2022 Aug 19.</citation>
      <PMID>35982520</PMID>
    </reference>
    <reference>
      <citation>Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.</citation>
      <PMID>35943235</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>spatial hearing</keyword>
    <keyword>virtual reality</keyword>
    <keyword>hearing loss</keyword>
    <keyword>rehabilitation</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040892
  org study id: 69HCL22_0893
  nct id: NCT06040892
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in
        children, leading to an improvement of their quality of life. However, spatial hearing skills
        of bCI children remain limited, even for children with the best speech understanding
        outcomes. Recent studies have brought new insights in spatial hearing by using virtual
        reality to record spatial hearing performance in 3D and the impact of active listening (i.e.
        free head exploration during sound emission): all bCI children showed spatial hearing
        difficulties related to front-back confusions and distance perception, which partly resulted
        from the reduction in auditory cues by the CI settings. However, bCI children notably
        improved under conditions of active listening, suggesting that interaction with environment
        could represent a rehabilitation entry strategy to help bCI users when faced with complex
        auditory scenes in daily life.
  
        The ability to localize sounds in space (spatial hearing) and the ability to understand
        speech in noise are both auditory skills essential in daily interactions with our physical
        and social environment and, when deficient, limit the quality of life. However, there is no
        specific rehabilitation program devoted to spatial hearing which could help children face
        their daily difficulties in noisy environments. Even though technological advances are
        crucial to improve the restoration of hearing functions, these improvements are also highly
        dependent on rehabilitation strategies to train our auditory brain to face the restoration of
        binaural processing or to decode the impoverished spectral information delivered by the CI.
  
        The investigators recently performed a pilot study in bCI adults who attended 8 training
        sessions of spatial hearing, involving a sensorial and interactive immersive environment
        (i.e. virtual reality with auditory and visual environment during an active listening task).
        All participants benefitted of the training, in terms of spatial hearing performance, speech
        understanding in noise, and quality of life. All early benefits were maintained 1 month after
        the end of training.
  
        The investigators aim to propose a spatial hearing rehabilitation program (KidTrain) adapted
        to bCI children from 8 to 17 years old, based on their previous pilot study on bCI adults.
        Their tool makes it possible to propose rehabilitation programs adapted to the performance
        and expectations of each child. This program will manipulate both the ambient sound with
        varying background noise to simulate daily life environments (i.e. making auditory detection
        more or less complex), and also manipulate virtual immersive environment (i.e. giving more or
        less relevant visual cues related to real sound location). The KidTrain's effects will be
        measured with different auditory tests performed in noisy environments. The investigators
        will also include Normal Hearing (NH) children as age-matched control groups to perform the
        auditory tests in noise. These NH groups will also bring new insights of spatial hearing
        maturation in complex auditory environments. Based on our preliminary data in bCI adults,
        this 'KidTrain program' should improve spatial hearing skills of bCI children, speech
        comprehension in noise and quality of life in many daily situations.
  
        Virtual reality (VR) has recently proven its effectiveness in rehabilitation in many domains
        and recent studies have shown that this technology has its place in the auditory evaluation
        and adaptation of spatial hearing. This VR approach takes advantage of the control of
        multisensory cues of our environment (audio and visual) during a spatial hearing task, and
        allows the subject to interact with his environment according to his hearing abilities and
        needs (i.e. active listening).
  
        Based on their previous study conducted in bCI and NH children and on their spatial training
        study conducted with bCI adults, the investigators wish to respond to the growing need of
        spatial hearing rehabilitation for bCI children. To achieve this goal, the investigators will
        improve the spatial training program by adding different immersive environment in VR with
        various background noise to simulate daily life environments. This approach will also be a
        great opportunity to characterize the developmental stages of spatial hearing maturation in
        NH children. Thus, this project will propose new axes of speech therapy on the Orthophonie &
        Surdité platform, combining spatial hearing and speech understanding in noise. This
        innovative and adapted rehabilitation program will lead the speech therapist to propose more
        adapted and effective rehabilitations for the daily life of deaf children.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.
  time frame: Immediately after 4 training sessions - day 42
  description: The effect of spatial rehabilitation will be defined as any change in auditory performance (SPHERE value), between the initial assessment and after 4 training sessions.
  measure: To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.
  time frame: Immediately after 4 training sessions - day 42
  description: The effect of spatial rehabilitation will be defined as any change in auditory performance (FRASIMAT value), between the initial assessment and after 4 training sessions.
  measure: To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.
  time frame: Immediately after 4 training sessions - day 42
  description: The effect of spatial rehabilitation will be defined as any change in auditory performance (KID-SSQ score), between the initial assessment and after 4 training sessions.
  measure: To evaluate the compliance of bCI children with the rehabilitation protocol
  time frame: At the end of the study ( Visit 13 - day 98)
  description: Number of training sessions attended by bCI patients
  measure: To evaluate the impact of a spatialized sensory index in rehabilitation.
  time frame: At the end of the study ( Visit 13 - day 98)
  description: Measures obtained at the E2 assessment (SPHERE value) between the group of bCI children in group A and those in group B.
  measure: To evaluate the impact of a spatialized sensory index in rehabilitation.
  time frame: At the end of the study ( Visit 13 - day 98)
  description: Measures obtained at the E2 assessment (FRASIMAT value) between the group of bCI children in group A and those in group B.
  measure: To evaluate the impact of a spatialized sensory index in rehabilitation.
  time frame: At the end of the study ( Visit 13 - day 98)
  description: Measures obtained at the E2 assessment (KID-SSQ score) between the group of bCI children in group A and those in group B.
  measure: To evaluate the effect in the very short/short and medium term of spatial hearing rehabilitation on the spatial sound localization performance of bIC children compared to NH children
  time frame: At evaluation visits Day 0, 42, 77 and 98
  description: SPHERE confusion rates (front-back, up-down, near-far) for bCI children at E2, E3 and E4 and NH children at E0.
  measure: To evaluate the effect of very short-term, short-term and medium-term spatial hearing rehabilitation on the speech comprehension performance of bIC children compared to NH children.
  time frame: At evaluation visits Day 0, 42, 77 and 98
  description: FRASIMAT noise intelligibility scores for bCI children in E2, E3 and E4 and those for NH children in E0.
  measure: To evaluate the effect of very short-term and short-term and medium-term spatial hearing rehabilitation on the quality of life performance of bIC children compared to NH children.
  time frame: At evaluation visits Day 0, 42, 77 and 98
  description: KID-SSQ spatial hearing scores obtained by bCI children in E2, E3 and E4 and those obtained by NH children in E0.
  measure: To assess the absence of spontaneous changes in auditory performance.
  time frame: At day 0 and 7
  description: SPHERE measure for the bCI and NH groups between the E0 and E1 assessments.
  measure: To assess the absence of spontaneous changes in auditory performance.
  time frame: At day 0 and 7
  description: FRASIMAT measure for the bCI and NH groups between the E0 and E1 assessments.
  measure: To assess the absence of spontaneous changes in auditory performance.
  time frame: At day 0 and 7
  description: KID SSQ measure for the bCI and NH groups between the E0 and E1 assessments.
  arm group label: Group A
  arm group type: Experimental
  description: bilateral cochlear implant children with rehabilitation including 8 sessions with a spatialized sensory index
  arm group label: Group B
  arm group type: Experimental
  description: bilateral cochlear implant children with rehabilitation including initially 4 sessions without spatialized sensory cue followed by 4 sessions with spatialized sensory cue
  arm group label: Normal hearing volunteers
  arm group type: Active Comparator
  description: Children without known hearing loss
  intervention type: Diagnostic Test
  intervention name: SPHERE protocol : Spatial hearing performances test
  description: Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHERE protocol).
  arm group label: Group A
  arm group label: Group B
  arm group label: Normal hearing volunteers
  intervention type: Diagnostic Test
  intervention name: FRASIMAT Test : audiology test of speech in noise perception
  description: Intelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening.
  arm group label: Group A
  arm group label: Group B
  arm group label: Normal hearing volunteers
  intervention type: Diagnostic Test
  intervention name: Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale
  description: The SSQ questionnaire is a clinical subjective scale that allows evaluating of hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten.
  arm group label: Group A
  arm group label: Group B
  arm group label: Normal hearing volunteers
  intervention type: Other
  intervention name: spatial hearing rehabilitation program
  description: The tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location).
  arm group label: Group A
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Aurélie Coudert, MD
  role: Study Chair
  affiliation: Hospices Civils de Lyon
  last name: Aurélie Coudert, MD
  phone: 0427855506
  phone ext: +33
  email: aurelie.coudert2@chu-lyon.fr
  last name: Valérie GAVEAU, MCU
  phone: 04 72 91 34 10
  phone ext: +33
  email: valerie.gaveau@inserm.fr
  facility: 
  contact: 
  contact backup: 
  country: France
  citation: Coudert A, Gaveau V, Gatel J, Verdelet G, Salemme R, Farne A, Pavani F, Truy E. Spatial Hearing Difficulties in Reaching Space in Bilateral Cochlear Implant Children Improve With Head Movements. Ear Hear. 2022 Jan/Feb;43(1):192-205. doi: 10.1097/AUD.0000000000001090.
  PMID: 34225320
  citation: Valzolgher C, Gatel J, Bouzaid S, Grenouillet S, Todeschini M, Verdelet G, Salemme R, Gaveau V, Truy E, Farne A, Pavani F. Reaching to Sounds Improves Spatial Hearing in Bilateral Cochlear Implant Users. Ear Hear. 2023 Jan-Feb 01;44(1):189-198. doi: 10.1097/AUD.0000000000001267. Epub 2022 Aug 19.
  PMID: 35982520
  citation: Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.
  PMID: 35943235
  responsible party type: Sponsor