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

Hearing Loss Clinical Trial

— FunSpeech  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454255
• Other study ID #: ID 2019-02138
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: June 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Behavioral:
• FunSpeech
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.
• Control
Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week).

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ergonomy questionnaire (ease of use) on a seven-point Likert scale (1 = strongly disagree to 7 = strongly agree).	Game usability	6 months
Other	Open interview (issues/concerns about the game)	Acceptance degree of the game	6 months
Primary	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	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