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/NCT05962814</url>
    </required_header>
    <id_info>
      <org_study_id>98058</org_study_id>
      <nct_id>NCT05962814</nct_id>
    </id_info>
    <brief_title>EarGenie: Assessment of a Minimum Viable Product</brief_title>
    <official_title>EarGenie: Assessment of a Minimum Viable Product</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Bionics Institute of Australia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Bionics Institute of Australia</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 goal of this clinical trial is to evaluate safety and preliminary efficacy of a novel&#xD;
        device (EarGenie MVP) to assess hearing function in infants, using a small number of infants&#xD;
        with normal hearing. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is our device safe?&#xD;
  &#xD;
          -  Does the device provide preliminary results consistent with previous results from a&#xD;
             commercial functional Near Infrared Spectroscopy (fNIRS) research device?&#xD;
  &#xD;
        Participants will attend one test session and have their hearing assessed with the EarGenie&#xD;
        MVP device.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a first-in-human study to evaluate safety and preliminary efficacy of our prototype&#xD;
        hearing assessment system (EarGenie MVP). EarGenie MVP uses fNIRS technology to assess an&#xD;
        infant's brain response to hearing speech sounds, or discriminating between different speech&#xD;
        sounds. It includes software to automatically run analysis in real time, and has a user&#xD;
        interface allowing clinicians to operate the tests and receive result reports. The test&#xD;
        methods and analysis software have been developed using our commercial fNIRS research system,&#xD;
        but the EarGenie MVP has been designed for easy use in paediatric audiology clinics.&#xD;
  &#xD;
        10 infants with normal hearing will be recruited for the study, and undergo one test session&#xD;
        each with the EarGenie MVP. Safety data will be documented and the results of the tests&#xD;
        examined to see if they are consistent with the results expected from our experience using&#xD;
        the commercial device in 36 infants with normal hearing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 14, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>
      <intervention_model_description>A single group of infants without hearing impairment will be recruited so that safety and preliminary efficacy can be determined.</intervention_model_description>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Prevalence of significant fNIRS detection and discrimination responses</measure>
      <time_frame>Through study completion, up to 3.5 months</time_frame>
      <description>Evidence of device feasibility will be obtained by comparing the test results obtained using EarGenie MVP to our existing test results for a larger number of infants obtained with a commercial device NIRx (McKay et al. 2023. &quot;A Reliable, Accurate, and Clinic-friendly Objective Test of Speech Sound Detection and Discrimination in Sleeping Infants.&quot; PsyArXiv. June 20. doi:10.31234/osf.io/fbwcm).&#xD;
  For each infant, the presence of a significant response is determined by the incorporated automatic analysis software, and further visually supported for the tester by checking that the shape of the response waveform is consistent with those found in the previous data set. We will consider the feasibility as confirmed if not more than 1(/10) infants (or 10%) have an absent detection response at 65 dB SPL, and not more than 3 (/10) babies (or 30%) show an absent discrimination response for &quot;Ba&quot; versus &quot;Ga&quot;.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
      <time_frame>Through study completion, up to 3.5 months</time_frame>
      <description>Safety assessment will be undertaken as follows. Any adverse event (as defined using standard definitions) will be documented in each infant's case report, and reported using standard required procedures. Each infant's case report will also include details of any minor non-reportable occurrences only relevant to comfort of use such as discomfort signs in the infant, or any temporary visual skin marks left by the headgear after the test.&#xD;
  If any major adverse effect occurs, the trial will be stopped until the such time as the issue is resolved.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Hearing Impaired Children</condition>
    <arm_group>
      <arm_group_label>fNIRS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Infants who have a test completed with EarGenie MVP in a single test session</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EarGenie MVP test</intervention_name>
      <description>The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests via the user interface. Blocks of speech sounds are presented to the infant via earphones or via speaker, and the EarGenie MVP measures changes in the blood oxygenation. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.</description>
      <arm_group_label>fNIRS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Is between the ages of 1 and 24 months at the time of fNIRS testing.&#xD;
  &#xD;
            -  Has no known hearing loss&#xD;
  &#xD;
            -  Has a legally acceptable representative capable of understanding the informed consent&#xD;
               document and providing consent on the participant's behalf.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  There are no exclusion criteria other than not meeting the inclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>24 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Colette M McKay, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bionics Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Colette M McKay, PhD</last_name>
      <phone>+61 408698202</phone>
      <email>cmckay@bionicsinstitute.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Julia Wunderlich, PhD</last_name>
      <phone>61 3 9667 7500</phone>
      <email>hearingstudy@bionicsinstitute.org</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Bionics Institute of Australia</investigator_affiliation>
      <investigator_full_name>Colette McKay</investigator_full_name>
      <investigator_title>Leader, Translational Hearing Research and Principal Scientist</investigator_title>
    </responsible_party>
    <keyword>fNIRS</keyword>
    <keyword>Early intervention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deafness</mesh_term>
      <mesh_term>Hearing Loss</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05962814
  org study id: 98058
  nct id: NCT05962814
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate safety and preliminary efficacy of a novel
        device (EarGenie MVP) to assess hearing function in infants, using a small number of infants
        with normal hearing. The main questions it aims to answer are:
  
          -  Is our device safe?
  
          -  Does the device provide preliminary results consistent with previous results from a
             commercial functional Near Infrared Spectroscopy (fNIRS) research device?
  
        Participants will attend one test session and have their hearing assessed with the EarGenie
        MVP device.
  This is a first-in-human study to evaluate safety and preliminary efficacy of our prototype
        hearing assessment system (EarGenie MVP). EarGenie MVP uses fNIRS technology to assess an
        infant's brain response to hearing speech sounds, or discriminating between different speech
        sounds. It includes software to automatically run analysis in real time, and has a user
        interface allowing clinicians to operate the tests and receive result reports. The test
        methods and analysis software have been developed using our commercial fNIRS research system,
        but the EarGenie MVP has been designed for easy use in paediatric audiology clinics.
  
        10 infants with normal hearing will be recruited for the study, and undergo one test session
        each with the EarGenie MVP. Safety data will be documented and the results of the tests
        examined to see if they are consistent with the results expected from our experience using
        the commercial device in 36 infants with normal hearing.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: A single group of infants without hearing impairment will be recruited so that safety and preliminary efficacy can be determined.
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Prevalence of significant fNIRS detection and discrimination responses
  time frame: Through study completion, up to 3.5 months
  description: Evidence of device feasibility will be obtained by comparing the test results obtained using EarGenie MVP to our existing test results for a larger number of infants obtained with a commercial device NIRx (McKay et al. 2023. "A Reliable, Accurate, and Clinic-friendly Objective Test of Speech Sound Detection and Discrimination in Sleeping Infants." PsyArXiv. June 20. doi:10.31234/osf.io/fbwcm).
  For each infant, the presence of a significant response is determined by the incorporated automatic analysis software, and further visually supported for the tester by checking that the shape of the response waveform is consistent with those found in the previous data set. We will consider the feasibility as confirmed if not more than 1(/10) infants (or 10%) have an absent detection response at 65 dB SPL, and not more than 3 (/10) babies (or 30%) show an absent discrimination response for "Ba" versus "Ga".
  measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
  time frame: Through study completion, up to 3.5 months
  description: Safety assessment will be undertaken as follows. Any adverse event (as defined using standard definitions) will be documented in each infant's case report, and reported using standard required procedures. Each infant's case report will also include details of any minor non-reportable occurrences only relevant to comfort of use such as discomfort signs in the infant, or any temporary visual skin marks left by the headgear after the test.
  If any major adverse effect occurs, the trial will be stopped until the such time as the issue is resolved.
  arm group label: fNIRS
  arm group type: Experimental
  description: Infants who have a test completed with EarGenie MVP in a single test session
  intervention type: Device
  intervention name: EarGenie MVP test
  description: The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests via the user interface. Blocks of speech sounds are presented to the infant via earphones or via speaker, and the EarGenie MVP measures changes in the blood oxygenation. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.
  arm group label: fNIRS
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: 24 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Colette M McKay, PhD
  role: Principal Investigator
  affiliation: Bionics Institute
  last name: Colette M McKay, PhD
  phone: +61 408698202
  email: cmckay@bionicsinstitute.org
  last name: Julia Wunderlich, PhD
  phone: 61 3 9667 7500
  email: hearingstudy@bionicsinstitute.org
  responsible party type: Principal Investigator
  investigator affiliation: The Bionics Institute of Australia
  investigator full name: Colette McKay
  investigator title: Leader, Translational Hearing Research and Principal Scientist
  mesh term: Deafness
  mesh term: Hearing Loss
  sharing ipd: No