<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/NCT04454255</url>
  </required_header>
  <id_info>
    <org_study_id>ID 2019-02138</org_study_id>
    <nct_id>NCT04454255</nct_id>
  </id_info>
  <brief_title>Benefits of Tablet-based Serious Games to Promote Speech Production in Young Children With Hearing Disabilities</brief_title>
  <acronym>FunSpeech</acronym>
  <official_title>Evaluating the Educational Benefits of Tablet-based Serious Games to Promote Speech Production in Instrumented Young Children With Hearing Disabilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Geneva, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</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>
      Learning to speak is a major challenge for children with hearing impairments. Nowadays,&#xD;
      special devices such as conventional hearing aids, bone-anchored hearing aids (BAHA) or&#xD;
      cochlear implants (CI) allow successful rehabilitation of patients with hearing disabilities.&#xD;
      To obtain maximum benefit from these technical aids, instrumented hearing impaired children&#xD;
      require specific and intensive speech therapy to compensate for speech development delays. In&#xD;
      addition, it is also of primary importance that during daily life (e.g., at home, at school)&#xD;
      children are provided with sufficient and good quality auditory stimulation.&#xD;
&#xD;
      The main goal of this project is to encourage speech production with an edutainment tool that&#xD;
      can be used at home and that is adapted to the specific needs of young hearing impaired&#xD;
      children. For this purpose, the investigators have recently designed an innovative&#xD;
      educational solution: FunSpeech, a tablet-based set of video games that respond exclusively&#xD;
      to sound and speech. The aim of this serious game is to encourage hearing impaired children&#xD;
      to produce controlled sounds in terms of rhythm, intensity, and pitch. These are the main&#xD;
      abilities required for controlled speech production. Finally, this serious game aims to&#xD;
      support the parents' key role in the speech learning process by offering an effective&#xD;
      solution that is easy to use at home with young children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Cross-over, repeated-measures, open without masking.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist.</measure>
    <time_frame>6 months</time_frame>
    <description>Quantitative and qualitative assessments of spoken language level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Game usage (total play time, frequency of play sessions, list of games used, gameplay goals achieved)</measure>
    <time_frame>6 months</time_frame>
    <description>This data will be gathered via a tracking system implemented in the game and parental interviews (questionnaires).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ergonomy questionnaire (ease of use) on a seven-point Likert scale (1 = strongly disagree to 7 = strongly agree).</measure>
    <time_frame>6 months</time_frame>
    <description>Game usability</description>
  </other_outcome>
  <other_outcome>
    <measure>Open interview (issues/concerns about the game)</measure>
    <time_frame>6 months</time_frame>
    <description>Acceptance degree of the game</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Deafness</condition>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Primo-FunSpeech</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will begin the study by a period using FunSpeech (45 days) followed by a control period without the game (45 days). This sequence will be repeated once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primo-control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will begin the study by a control period without the game (45 days) followed by a period using FunSpeech (45 days). This sequence will be repeated once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FunSpeech</intervention_name>
    <description>Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week) and parent-supervised home use of a serious game. It will be recommended to use FunSpeech every day, 15 minutes per day.</description>
    <arm_group_label>Primo-FunSpeech</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week).</description>
    <arm_group_label>Primo-control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with mild to profound hearing loss,&#xD;
&#xD;
          -  Optimum instrumented hearing (hearing aids, BAHA or CI),&#xD;
&#xD;
          -  Language development delay confirmed by a speech therapist,&#xD;
&#xD;
          -  Enough sensorimotor, cognitive and communication skills to play with tablet-based&#xD;
             games,&#xD;
&#xD;
          -  French mother tongue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Additional impairments which affect language development or the use of FunSpeech (e.g.&#xD;
             motor, orofacial, sensory, cognitive),&#xD;
&#xD;
          -  Refusal of the participant's representative(s) to participate in the study,&#xD;
&#xD;
          -  Refusal of the participant's representative(s) to participate in a modality of the&#xD;
             study,&#xD;
&#xD;
          -  If the child/participant refuses to collaborate in two measures of language level.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Geneva University Hospitals</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>March 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Angelica Perez Fornos</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Serious game</keyword>
  <keyword>Speech development</keyword>
  <keyword>Speech production</keyword>
  <keyword>Cochlear implant</keyword>
  <keyword>Hearing aid</keyword>
  <keyword>Bone anchored hearing aid</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>
  </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/NCT04454255
org study id: ID 2019-02138
nct id: NCT04454255
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Learning to speak is a major challenge for children with hearing impairments. Nowadays,
      special devices such as conventional hearing aids, bone-anchored hearing aids (BAHA) or
      cochlear implants (CI) allow successful rehabilitation of patients with hearing disabilities.
      To obtain maximum benefit from these technical aids, instrumented hearing impaired children
      require specific and intensive speech therapy to compensate for speech development delays. In
      addition, it is also of primary importance that during daily life (e.g., at home, at school)
      children are provided with sufficient and good quality auditory stimulation.

      The main goal of this project is to encourage speech production with an edutainment tool that
      can be used at home and that is adapted to the specific needs of young hearing impaired
      children. For this purpose, the investigators have recently designed an innovative
      educational solution: FunSpeech, a tablet-based set of video games that respond exclusively
      to sound and speech. The aim of this serious game is to encourage hearing impaired children
      to produce controlled sounds in terms of rhythm, intensity, and pitch. These are the main
      abilities required for controlled speech production. Finally, this serious game aims to
      support the parents' key role in the speech learning process by offering an effective
      solution that is easy to use at home with young children.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Cross-over, repeated-measures, open without masking.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist.
time frame: 6 months
description: Quantitative and qualitative assessments of spoken language level.
measure: Game usage (total play time, frequency of play sessions, list of games used, gameplay goals achieved)
time frame: 6 months
description: This data will be gathered via a tracking system implemented in the game and parental interviews (questionnaires).
measure: Ergonomy questionnaire (ease of use) on a seven-point Likert scale (1 = strongly disagree to 7 = strongly agree).
time frame: 6 months
description: Game usability
measure: Open interview (issues/concerns about the game)
time frame: 6 months
description: Acceptance degree of the game
arm group label: Primo-FunSpeech
arm group type: Experimental
description: Participants will begin the study by a period using FunSpeech (45 days) followed by a control period without the game (45 days). This sequence will be repeated once.
arm group label: Primo-control
arm group type: Experimental
description: Participants will begin the study by a control period without the game (45 days) followed by a period using FunSpeech (45 days). This sequence will be repeated once.
intervention type: Behavioral
intervention name: FunSpeech
description: Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week) and parent-supervised home use of a serious game. It will be recommended to use FunSpeech every day, 15 minutes per day.
arm group label: Primo-FunSpeech
intervention type: Behavioral
intervention name: Control
description: Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week).
arm group label: Primo-control
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Years
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Angelica Perez Fornos
investigator title: Principal Investigator
mesh term: Hearing Loss
mesh term: Deafness
sharing ipd: No