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Completed

NCT Number: NCT04454255

Benefits of Tablet-based Serious Games to Promote Speech Production in 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.

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Key information

Conditions

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

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals

Geneva, 1205, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Other outcomes

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

    Time frame: 6 months

    Game usability

  2. Open interview (issues/concerns about the game)

    Time frame: 6 months

    Acceptance degree of the game

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • University of Geneva, Switzerland

Registry information

Official study title

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

Acronym: FunSpeech

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2020
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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