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

June 21, 2023 updated by: Angelica Perez Fornos, University Hospital, Geneva

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Geneva, Switzerland, 1205
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist.
Time Frame: 6 months
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)
Time Frame: 6 months
This data will be gathered via a tracking system implemented in the game and parental interviews (questionnaires).
6 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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