- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04454255
Benefits of Tablet-based Serious Games to Promote Speech Production in Young Children With Hearing Disabilities (FunSpeech)
Evaluating the Educational Benefits of Tablet-based Serious Games to Promote Speech Production in Instrumented Young Children With Hearing Disabilities
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Geneva, Switzerland, 1205
- Geneva University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with mild to profound hearing loss,
- Optimum instrumented hearing (hearing aids, BAHA or CI),
- Language development delay confirmed by a speech therapist,
- Enough sensorimotor, cognitive and communication skills to play with tablet-based games,
- French mother tongue
Exclusion Criteria:
- Additional impairments which affect language development or the use of FunSpeech (e.g. motor, orofacial, sensory, cognitive),
- Refusal of the participant's representative(s) to participate in the study,
- Refusal of the participant's representative(s) to participate in a modality of the study,
- If the child/participant refuses to collaborate in two measures of language level.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Primo-FunSpeech
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.
|
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.
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Experimental: Primo-control
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.
|
Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist.
Time Frame: 6 months
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Quantitative and qualitative assessments of spoken language level.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Game usage (total play time, frequency of play sessions, list of games used, gameplay goals achieved)
Time Frame: 6 months
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This data will be gathered via a tracking system implemented in the game and parental interviews (questionnaires).
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ergonomy questionnaire (ease of use) on a seven-point Likert scale (1 = strongly disagree to 7 = strongly agree).
Time Frame: 6 months
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Game usability
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6 months
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Open interview (issues/concerns about the game)
Time Frame: 6 months
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Acceptance degree of the game
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID 2019-02138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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