Clinical trial NCT04454255: Benefits of Tablet-based Serious Games to Promote Speech Production in Young Children With Hearing Disabilities
Official title: Evaluating the Educational Benefits of Tablet-based Serious Games to Promote Speech Production in Instrumented Young Children With Hearing Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deafness
Hearing Loss
Keywords: Serious game
Speech development
Speech production
Cochlear implant
Hearing aid
Bone anchored hearing aid
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
First posted: 2020-07-01
Enrollment: 13
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over, repeated-measures, open without masking.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist.
timeFrame: 6 months
Secondary outcomes:
measure: Game usage (total play time, frequency of play sessions, list of games used, gameplay goals achieved)
timeFrame: 6 months
Other outcomes:
measure: Ergonomy questionnaire (ease of use) on a seven-point Likert scale (1 = strongly disagree to 7 = strongly agree).
timeFrame: 6 months
measure: Open interview (issues/concerns about the game)
timeFrame: 6 months
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References: