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

NCT04454255 | Completed

• 1 other identifier: ID 2019-02138
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness; Hearing Loss

Keywords

Serious game; Speech development; Speech production; Cochlear implant; Hearing aid; Bone anchored hearing aid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Game usage (total play time, frequency of play sessions, list of games used, gameplay goals achieved)

  6 months

Other Outcomes (2)

• Ergonomy questionnaire (ease of use) on a seven-point Likert scale (1 = strongly disagree to 7 = strongly agree).

  6 months

• Open interview (issues/concerns about the game)

  6 months

Study Arms (2)

Primo-FunSpeech

EXPERIMENTAL

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

Primo-control

EXPERIMENTAL

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

Interventions

FunSpeech BEHAVIORAL

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.

Primo-FunSpeech

Control BEHAVIORAL

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

Primo-control

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University of Geneva, Switzerland: collaborator

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Deafness; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cross-over, repeated-measures, open without masking.

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: July 1, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)