<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/NCT04473729</url>
  </required_header>
  <id_info>
    <org_study_id>Listening2Faces</org_study_id>
    <secondary_id>3R43DC017405-01A1S1</secondary_id>
    <nct_id>NCT04473729</nct_id>
  </id_info>
  <brief_title>Improving Perception of Speech in Noise in Children With Communication Disorders</brief_title>
  <acronym>L2F</acronym>
  <official_title>Improving Perception of Speech in Noise in Children With Communication Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smarty Ears</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southern Connecticut State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Haskins Laboratories</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Smarty Ears</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>
      Smarty Ears has developed a prototype of an innovative therapeutic training system to improve&#xD;
      speech perception in noise by training children on interrupted noise (which has silent&#xD;
      intervals that allow for fragments of the target to be heard). The study will attempt to&#xD;
      validate the technology and gather initial design feedback from clinicians and caregivers and&#xD;
      from children with ASD and HL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent evidence indicates that listening in interrupted noise can provide perceptual&#xD;
      benefits, such as remapping the auditory environment and learning to use acoustic cues. The&#xD;
      developed technology, uses adaptive listening training that automatically increases noise&#xD;
      level difficulty as performance improves, and includes age appropriate rewards to maintain&#xD;
      interest. The mobile app includes an initial and final screening, a training system that&#xD;
      administers training via the child's own mobile device, and detailed performance dashboard.&#xD;
      The study will attempt to validate the technology by gathering feedback from clinicians and&#xD;
      caregivers and from children with ASD and HL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</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>Sequential Assignment</intervention_model>
    <intervention_model_description>The model is ABA design, that is participants get an initial, pre-treatment noise assessment, then get individualized training, then get a post-noise assessment. This is designed to look for change from baseline after training.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily training performance</measure>
    <time_frame>5 days a week for 4 weeks (30 minutes/day)</time_frame>
    <description>Daily performance level based on words correct as a function of SNR and the average SNR over the course of training for 4 weeks</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Speech Perception</condition>
  <arm_group>
    <arm_group_label>Children with an autism spectrum disorder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention as described above with children with an ASD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children with Hearing Loss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Typically developing children with normal hearing acuity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Audiovisual speech training in noise for children</intervention_name>
    <description>Children will participate in listening training in the form of an iPad app</description>
    <arm_group_label>Children with Hearing Loss</arm_group_label>
    <arm_group_label>Children with an autism spectrum disorder</arm_group_label>
    <arm_group_label>Typically developing children with normal hearing acuity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For all children: normal or corrected to normal vision.&#xD;
&#xD;
          -  For children with typical development normal or corrected to normal vision + normal&#xD;
             hearing.&#xD;
&#xD;
          -  For children with HL Children must have at least one year experience with&#xD;
             amplification (i.e Hearing aids) and no threshold&gt; 70 dB.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To participate, all children must be able to comply with directions and engage in&#xD;
             tasks that require some expressive language response on the language and cognitive&#xD;
             measures (i.e. children who are considered to be in the &quot;word combinations&quot; or&#xD;
             &quot;sentences expressive language&quot; phase; Tager-Flusberg et al., 2009).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara Fernandes, M.S</last_name>
    <role>Principal Investigator</role>
    <affiliation>Smarty Ears</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern Connecticut State University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06515</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hampton University</name>
      <address>
        <city>Hampton</city>
        <state>Virginia</state>
        <zip>23669</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.smartyearsapps.com</url>
    <description>Link to Small Business/PI on study</description>
  </link>
  <results_reference>
    <citation>Irwin J, Preston J, Brancazio L, D'angelo M, Turcios J. Development of an audiovisual speech perception app for children with autism spectrum disorders. Clin Linguist Phon. 2015 Jan;29(1):76-83. doi: 10.3109/02699206.2014.966395. Epub 2014 Oct 14.</citation>
    <PMID>25313714</PMID>
  </results_reference>
  <results_reference>
    <citation>Irwin JR, Tornatore LA, Brancazio L, Whalen DH. Can children with autism spectrum disorders &quot;hear&quot; a speaking face? Child Dev. 2011 Sep-Oct;82(5):1397-403. doi: 10.1111/j.1467-8624.2011.01619.x. Epub 2011 Jul 25.</citation>
    <PMID>21790542</PMID>
  </results_reference>
  <results_reference>
    <citation>Irwin JR, Brancazio L. Seeing to hear? Patterns of gaze to speaking faces in children with autism spectrum disorders. Front Psychol. 2014 May 8;5:397. doi: 10.3389/fpsyg.2014.00397. eCollection 2014.</citation>
    <PMID>24847297</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>August 27, 2021</last_update_submitted>
  <last_update_submitted_qc>August 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASD</keyword>
  <keyword>speech in noise</keyword>
  <keyword>Hearing Loss</keyword>
  <keyword>speech-to-noise ratio</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communication Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 8, 2022</submitted>
    <returned>December 6, 2022</returned>
  </pending_results>
  <!-- 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/NCT04473729
org study id: Listening2Faces
secondary id: 3R43DC017405-01A1S1
nct id: NCT04473729
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Smarty Ears has developed a prototype of an innovative therapeutic training system to improve
      speech perception in noise by training children on interrupted noise (which has silent
      intervals that allow for fragments of the target to be heard). The study will attempt to
      validate the technology and gather initial design feedback from clinicians and caregivers and
      from children with ASD and HL.
Recent evidence indicates that listening in interrupted noise can provide perceptual
      benefits, such as remapping the auditory environment and learning to use acoustic cues. The
      developed technology, uses adaptive listening training that automatically increases noise
      level difficulty as performance improves, and includes age appropriate rewards to maintain
      interest. The mobile app includes an initial and final screening, a training system that
      administers training via the child's own mobile device, and detailed performance dashboard.
      The study will attempt to validate the technology by gathering feedback from clinicians and
      caregivers and from children with ASD and HL.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: The model is ABA design, that is participants get an initial, pre-treatment noise assessment, then get individualized training, then get a post-noise assessment. This is designed to look for change from baseline after training.
primary purpose: Treatment
masking: None (Open Label)
measure: Daily training performance
time frame: 5 days a week for 4 weeks (30 minutes/day)
description: Daily performance level based on words correct as a function of SNR and the average SNR over the course of training for 4 weeks
arm group label: Children with an autism spectrum disorder
arm group type: Experimental
description: The intervention as described above with children with an ASD.
arm group label: Children with Hearing Loss
arm group type: Experimental
arm group label: Typically developing children with normal hearing acuity
arm group type: Experimental
intervention type: Other
intervention name: Audiovisual speech training in noise for children
description: Children will participate in listening training in the form of an iPad app
arm group label: Children with Hearing Loss
arm group label: Children with an autism spectrum disorder
arm group label: Typically developing children with normal hearing acuity
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara Fernandes, M.S
role: Principal Investigator
affiliation: Smarty Ears
facility: 
facility: 
country: United States
url: http://www.smartyearsapps.com
description: Link to Small Business/PI on study
citation: Irwin J, Preston J, Brancazio L, D'angelo M, Turcios J. Development of an audiovisual speech perception app for children with autism spectrum disorders. Clin Linguist Phon. 2015 Jan;29(1):76-83. doi: 10.3109/02699206.2014.966395. Epub 2014 Oct 14.
PMID: 25313714
citation: Irwin JR, Tornatore LA, Brancazio L, Whalen DH. Can children with autism spectrum disorders "hear" a speaking face? Child Dev. 2011 Sep-Oct;82(5):1397-403. doi: 10.1111/j.1467-8624.2011.01619.x. Epub 2011 Jul 25.
PMID: 21790542
citation: Irwin JR, Brancazio L. Seeing to hear? Patterns of gaze to speaking faces in children with autism spectrum disorders. Front Psychol. 2014 May 8;5:397. doi: 10.3389/fpsyg.2014.00397. eCollection 2014.
PMID: 24847297
responsible party type: Sponsor
mesh term: Communication Disorders
sharing ipd: No
submitted: November 8, 2022
returned: December 6, 2022