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

NCT ID: NCT04454255

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FunSpeech

Intervention Type: 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-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.

Group Type: EXPERIMENTAL

Control

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Control

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

Intervention Type: BEHAVIORAL

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.

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Geneva, Switzerland

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Angelica Perez Fornos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Geneva University Hospitals

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

ID 2019-02138

Identifier Type: -

Identifier Source: org_study_id