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/NCT05985473</url>
    </required_header>
    <id_info>
      <org_study_id>2022-016</org_study_id>
      <secondary_id>2023-A00140-45</secondary_id>
      <nct_id>NCT05985473</nct_id>
    </id_info>
    <brief_title>Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement</brief_title>
    <acronym>REFINED</acronym>
    <official_title>Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut Pasteur</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut Pasteur</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>
        Individuals with Auditory Neuropathy Spectrum Disorders (ANSD) represent 1-10% of adults with&#xD;
        hearing loss. These individuals have little or no benefit from current hearing aids because&#xD;
        ANSD is a continuum of hearing impairments due to synaptic or neural dysfunction in the&#xD;
        peripheral and central parts of the auditory pathways, which impairs temporal information&#xD;
        processing without necessarily affecting auditory sensitivity. There is a need to find ad-hoc&#xD;
        denoising methods, based on the expert knowledge of audiologists, to improve the noise&#xD;
        comprehension performance of these patients. Implemented denoising methods, based on&#xD;
        artificial intelligence, will also greatly benefit more standard hearing loss cases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Longitudinal study consisting of multiple visits with multiple examinations over a total&#xD;
        duration of approximately 3 years per ANSD participant and 1 year per normal hearing&#xD;
        participant.&#xD;
  &#xD;
          -  normal hearing participant : year 1 : Inclusion visit, Phenotyping visit (Audiological&#xD;
             tests), Follow-up Visit 1 (Noise Comprehension Tests)&#xD;
  &#xD;
          -  ANSD participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests),&#xD;
             Follow-up Visit 1 (Noise Comprehension Tests) year 2 : Follow-up Visit 2 (Noise&#xD;
             Comprehension Tests) year 3 : Follow-up Visit 3 (Noise Comprehension Tests)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2026</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison of percentage of words correctly repeated by participants (ANSD and controls)</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluate intelligibility, i.e. the percentage of words correctly repeated, for different speech and noise conditions. Tests will be repeated with and without application of speech enhancement methods to the sound.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Auditory Brain Response (ABRs)</measure>
      <time_frame>3 years</time_frame>
      <description>Electrical activity of auditoral pathways, from the auditory nerve to the brain, in response to sound stimuli.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluate intelligibility and performance of source localisation for different angles of separation of speech and noises sources</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of phonemes correctly repeated by participants (Verbo-Frequential Audiometry in the presence of calibrated noise: the DODELE AVfB test)</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluate speech perception in noise with phonemes as testing speech</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of words correctly repeated by participants at different sound level of noise</measure>
      <time_frame>3 years</time_frame>
      <description>Assess intelligibility in noise. Vocal tests will be repeated with and without tactile cues.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP).</measure>
      <time_frame>3 years</time_frame>
      <description>c-VEMP assesses the vestibular function through saccular and inferior vestibular nerve function performances. The collected parameters of c-VEMP testing include c-VEMP threshold, the latencies of the initial positivity (p1) and negativity (n1), and the p1-n1 inter-amplitude. We will collect these parameters and assess differences in controls vs. ANSDs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective evaluation of listening comfort using a visual analog scale</measure>
      <time_frame>3 years</time_frame>
      <description>This self-assessment involves placing a cursor on a scale ranging from &quot;very uncomfortable to very comfortable&quot; using a scale ranging from 0 to 10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective evaluation of listening efficiency using a visual analog scale</measure>
      <time_frame>3 years</time_frame>
      <description>This self-assessment involves placing a cursor on a scale ranging from &quot;very inefficient to very efficient&quot; using a scale ranging from 0 to 10.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Deafness Neurosensory</condition>
    <arm_group>
      <arm_group_label>Professionally active adults with a moderate hearing loss</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>audiological measurements</intervention_name>
      <description>audiological measurements</description>
      <arm_group_label>Professionally active adults with a moderate hearing loss</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Objective and subjective audiological measurements</intervention_name>
      <description>Objective and subjective audiological measurements</description>
      <arm_group_label>Professionally active adults with a moderate hearing loss</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Evaluation of the denoising methods REFINED</intervention_name>
      <description>Evaluation of the denoising methods REFINED</description>
      <arm_group_label>Professionally active adults with a moderate hearing loss</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For all participants:&#xD;
  &#xD;
            -  Age greater than or equal to 18 years,&#xD;
  &#xD;
            -  French mother tongue,&#xD;
  &#xD;
            -  Have an average tonal hearing loss (calculated according to the BIAP method) &lt; 30 dB&#xD;
               HL, on headphones, for each ear,&#xD;
  &#xD;
            -  Be professionally active, not be pre-retired and not be unemployed&#xD;
  &#xD;
            -  Be affiliated with a social security plan,&#xD;
  &#xD;
          For participants with TSNA:&#xD;
  &#xD;
          - Have degraded comprehension in noise (threshold of Intelligibility in Noise &gt; 3 dB&#xD;
          compared to the norm).&#xD;
  &#xD;
          For controls:&#xD;
  &#xD;
          - Have normal comprehension in noise (Intelligibility in Noise threshold ≤ 3 dB from the&#xD;
          norm).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          For all participants:&#xD;
  &#xD;
            -  Have a conductive or mixed hearing loss, which is when the hearing loss affects both&#xD;
               the outer and/or middle ear and the inner ear.&#xD;
  &#xD;
            -  Have an asymmetric hearing loss, i.e. a difference in average hearing loss between the&#xD;
               left and right ear greater than 30 dB,&#xD;
  &#xD;
            -  Have sequelae of ear infections and/or a history of ENT disease that permanently&#xD;
               affects hearing (vestibular schwannoma, Meniere's disease, sudden or fluctuating&#xD;
               deafness, congenital hypoacusis)&#xD;
  &#xD;
            -  Being under guardianship,&#xD;
  &#xD;
            -  Being deprived of liberty by judicial or administrative decision, or being subject to&#xD;
               legal protection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Paul Avan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CEntre de Recherche et d'Innovation en Audiologie Humain</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marta Campi, PhD</last_name>
      <phone>++33 (0) 1 76 53 51 12</phone>
      <email>marta.campi@pasteur.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Paul Avan, MD</last_name>
      <phone>+33 (0)1 76 53 50 94</phone>
      <email>paul.avan@uca.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CEntre de Recherche et d'Innovation en Audiologie Humaine</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Paul Avan, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Spectrum of auditory neuropathy</keyword>
    <keyword>speech enhancement</keyword>
    <keyword>intelligibility</keyword>
    <keyword>denoising methods</keyword>
    <keyword>hearing loss</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deafness</mesh_term>
      <mesh_term>Hearing Loss, Sensorineural</mesh_term>
    </condition_browse>
    <!-- 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/NCT05985473
  org study id: 2022-016
  secondary id: 2023-A00140-45
  nct id: NCT05985473
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Individuals with Auditory Neuropathy Spectrum Disorders (ANSD) represent 1-10% of adults with
        hearing loss. These individuals have little or no benefit from current hearing aids because
        ANSD is a continuum of hearing impairments due to synaptic or neural dysfunction in the
        peripheral and central parts of the auditory pathways, which impairs temporal information
        processing without necessarily affecting auditory sensitivity. There is a need to find ad-hoc
        denoising methods, based on the expert knowledge of audiologists, to improve the noise
        comprehension performance of these patients. Implemented denoising methods, based on
        artificial intelligence, will also greatly benefit more standard hearing loss cases.
  Longitudinal study consisting of multiple visits with multiple examinations over a total
        duration of approximately 3 years per ANSD participant and 1 year per normal hearing
        participant.
  
          -  normal hearing participant : year 1 : Inclusion visit, Phenotyping visit (Audiological
             tests), Follow-up Visit 1 (Noise Comprehension Tests)
  
          -  ANSD participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests),
             Follow-up Visit 1 (Noise Comprehension Tests) year 2 : Follow-up Visit 2 (Noise
             Comprehension Tests) year 3 : Follow-up Visit 3 (Noise Comprehension Tests)
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Comparison of percentage of words correctly repeated by participants (ANSD and controls)
  time frame: 3 years
  description: Evaluate intelligibility, i.e. the percentage of words correctly repeated, for different speech and noise conditions. Tests will be repeated with and without application of speech enhancement methods to the sound.
  measure: Auditory Brain Response (ABRs)
  time frame: 3 years
  description: Electrical activity of auditoral pathways, from the auditory nerve to the brain, in response to sound stimuli.
  measure: Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources
  time frame: 3 years
  description: Evaluate intelligibility and performance of source localisation for different angles of separation of speech and noises sources
  measure: Percentage of phonemes correctly repeated by participants (Verbo-Frequential Audiometry in the presence of calibrated noise: the DODELE AVfB test)
  time frame: 3 years
  description: Evaluate speech perception in noise with phonemes as testing speech
  measure: Percentage of words correctly repeated by participants at different sound level of noise
  time frame: 3 years
  description: Assess intelligibility in noise. Vocal tests will be repeated with and without tactile cues.
  measure: Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP).
  time frame: 3 years
  description: c-VEMP assesses the vestibular function through saccular and inferior vestibular nerve function performances. The collected parameters of c-VEMP testing include c-VEMP threshold, the latencies of the initial positivity (p1) and negativity (n1), and the p1-n1 inter-amplitude. We will collect these parameters and assess differences in controls vs. ANSDs.
  measure: Subjective evaluation of listening comfort using a visual analog scale
  time frame: 3 years
  description: This self-assessment involves placing a cursor on a scale ranging from "very uncomfortable to very comfortable" using a scale ranging from 0 to 10.
  measure: Subjective evaluation of listening efficiency using a visual analog scale
  time frame: 3 years
  description: This self-assessment involves placing a cursor on a scale ranging from "very inefficient to very efficient" using a scale ranging from 0 to 10.
  arm group label: Professionally active adults with a moderate hearing loss
  arm group type: Other
  intervention type: Other
  intervention name: audiological measurements
  description: audiological measurements
  arm group label: Professionally active adults with a moderate hearing loss
  intervention type: Other
  intervention name: Objective and subjective audiological measurements
  description: Objective and subjective audiological measurements
  arm group label: Professionally active adults with a moderate hearing loss
  intervention type: Other
  intervention name: Evaluation of the denoising methods REFINED
  description: Evaluation of the denoising methods REFINED
  arm group label: Professionally active adults with a moderate hearing loss
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Paul Avan, MD
  role: Principal Investigator
  affiliation: CEntre de Recherche et d'Innovation en Audiologie Humain
  last name: Marta Campi, PhD
  phone: ++33 (0) 1 76 53 51 12
  email: marta.campi@pasteur.fr
  last name: Paul Avan, MD
  phone: +33 (0)1 76 53 50 94
  email: paul.avan@uca.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Deafness
  mesh term: Hearing Loss, Sensorineural