DeafnessFunSpeechNCT04454255
Benefits of Tablet-based Serious Games to Promote Speech Production in Young Children With Hearing Disabilities
A study testing FunSpeech in people with Deafness and Hearing Loss, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Deafness, Hearing Loss
- What is being tested?
- FunSpeech
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Deafness, Hearing Loss
- Being tested
- FunSpeech, Control
- Keywords
- Serious game, Speech development, Speech production, Cochlear implant, Hearing aid, Bone anchored hearing aid
- Medical subject headings
- Deafness, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FunSpeechBehavioural
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.
ControlBehavioural
Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist.
Quantitative and qualitative assessments of spoken language level.
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over, repeated-measures, open without masking.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Principal investigator, Angelica Perez Fornos, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454255
- Sponsor's protocol ID
- ID 2019-02138
- Acronym
- FunSpeech
- Status last verified
- Jun 2023
- First submitted
- 5 Mar 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Educational Benefits of Tablet-based Serious Games to Promote Speech Production in Instrumented Young Children With Hearing Disabilities
- ClinicalTrials.gov ID
- NCT04454255
- Acronym / sponsor ID
- FunSpeech / ID 2019-02138
- Conditions
- Deafness, Hearing Loss
- Keywords
- Serious game, Speech development, Speech production, Cochlear implant, Hearing aid, Bone anchored hearing aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-over, repeated-measures, open without masking.
| Arm | Type | Receives |
|---|---|---|
| Primo-FunSpeech | Experimental | Behavioral: FunSpeechParticipants 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. |
| Primo-control | Experimental | Behavioral: ControlParticipants 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. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FunSpeechWeekly 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. | Behavioural | Primo-FunSpeech |
| ControlWeekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week). | Behavioural | Primo-control |
Primary outcome
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.
1 secondary outcome
Game usage (total play time, frequency of play sessions, list of games used, gameplay goals achieved)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FunSpeech in people with Deafness and Hearing Loss, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental inventory (questionnaire) and observation grid of speech production skills completed by the speech therapist. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.