Benefits of Tablet-based Serious Games to Promote Speech Production in Young Children With Hearing Disabilities

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Educational Benefits of Tablet-based Serious Games to Promote Speech Production in Instrumented Young Children With Hearing Disabilities

Conditions
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Deafness, Hearing Loss

Intervention / Treatment
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* Behavioral: FunSpeech
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross-over, repeated-measures, open without masking.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primo-FunSpeech<br>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. | Behavioral: FunSpeech<br>* 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.<br>|
| Experimental: Primo-control<br>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. | Behavioral: Control<br>* Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist. | Quantitative and qualitative assessments of spoken language level. | 6 months | 

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) | This data will be gathered via a tracking system implemented in the game and parental interviews (questionnaires). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serious game, Speech development, Speech production, Cochlear implant, Hearing aid, Bone anchored hearing aid