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

Primary Purpose

Deafness, Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
FunSpeech
Control
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Deafness focused on measuring Serious game, Speech development, Speech production, Cochlear implant, Hearing aid, Bone anchored hearing aid

Eligibility Criteria

undefined - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primo-FunSpeech

Primo-control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist.
Quantitative and qualitative assessments of spoken language level.

Secondary Outcome Measures

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).

Full Information

First Posted
March 5, 2020
Last Updated
June 21, 2023
Sponsor
University Hospital, Geneva
Collaborators
University of Geneva, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04454255
Brief Title
Benefits of Tablet-based Serious Games to Promote Speech Production in Young Children With Hearing Disabilities
Acronym
FunSpeech
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
University of Geneva, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Hearing Loss
Keywords
Serious game, Speech development, Speech production, Cochlear implant, Hearing aid, Bone anchored hearing aid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cross-over, repeated-measures, open without masking.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primo-FunSpeech
Arm Type
Experimental
Arm Description
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.
Arm Title
Primo-control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FunSpeech
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week).
Primary Outcome Measure Information:
Title
Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist.
Description
Quantitative and qualitative assessments of spoken language level.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Game usage (total play time, frequency of play sessions, list of games used, gameplay goals achieved)
Description
This data will be gathered via a tracking system implemented in the game and parental interviews (questionnaires).
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Ergonomy questionnaire (ease of use) on a seven-point Likert scale (1 = strongly disagree to 7 = strongly agree).
Description
Game usability
Time Frame
6 months
Title
Open interview (issues/concerns about the game)
Description
Acceptance degree of the game
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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