AzTrials
AzTrials

Children With Cochlear ImplantNCT00947778

Analysis of Language and Auditory Abilities in Cochlear Implanted Children

A study testing 3 sessions of evaluation tests and 1 training session in people with Children With Cochlear Implant, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The cochlear implant appears today as one of the best technique so as to lead the congenital deaf children to speak. However the results in terms of accurate access to language remain partial. Read more about this study

Who is it for?
Ages 4 to 10 years
Conditions the study is for
Children With Cochlear Implant
What is being tested?
3 sessions of evaluation tests and 1 training session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteFrance
Study dates
Jul 2009to Nov 2010
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 4 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • children with congenital deaf to speak
  • children with cochlear implant Nucleus

Who cannot join

  • children unable to understand orders in the oral or in the language of signs

Trial locations and contacts

1 site in 1 country.

France1 site
  • Assistance Publique-Hopitaux de Marseille

    Marseille

Other trials in France

About this study

Official title: Analysis of Language and Auditory Abilities in Cochlear Implanted Children: Assessment by an Auditory Learning Programmed Method

The cochlear implant appears today as one of the best technique so as to lead the congenital deaf children to speak. However the results in terms of accurate access to language remain partial. These results are usually due to the children own factors (social, educational and handicap ones), one which any action has a limited effect.

Besides, there are external factors on which one can rely : " treatments ". For instance, an early cochlear implant on a child is the main stream to a better access to speak properly later. Another essential point to tackle is the early re-education training which remains essential to the treatment. Yet, there is a gap to fill between the theory and the main assistance in the auditory education practice.

Read more

The main objective of this survey is to evaluate the efficiency of this auditory teaching programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf children aged from 4 to 10.

This study will be divided into two phases separated by 3 sessions of evaluation tests.

The first session T1 will occur in the two groups (experimentation on G1 and control on G2), then the first training session will start in group G1.

The second session T2 will occur in the two groups, then the first training session will start in group G2.

The third session T3 will occur in the 2 groups at the end of the experiment.

By training the 4 perceptible operations with different auditory stimulations (speech, music, sounds and electro-acoustic sounds), we are looking for better performance in the trained skills as well as a teaching transfer on other linguistic abilities (phonetics discrimination and speech).

Read the detailed description

The cochlear implant appears today as one of the best technique so as to lead the congenital deaf children to speak. However the results in terms of accurate access to language remain partial. These results are usually due to the children own factors (social, educational and handicap ones), one which any action has a limited effect.

Besides, there are external factors on which one can rely : " treatments ". For instance, an early cochlear implant on a child is the main stream to a better access to speak properly later. Another essential point to tackle is the early re-education training which remains essential to the treatment. Yet, there is a gap to fill between the theory and the main assistance in the auditory education practice.

Researches on auditory cognitive sciences make the distinctions between different operation treatments ranged from the identification of sounds sources to the discrimination of specific acoustic parameters to the analysis of auditory scenes and the memorization of its sources. (Mc Adams and Bigand, 1994).Each operation implies a specific treatment.

Yet, these operations are not systematically followed by a re-education treatment among deaf children even if one is to know that it has a positive impact on the linguistic skills.

They can be trained by a large range of non linguistic stimuli as these specific stimuli belong to the fundamental auditory cognition, their development lead to benefits on the treatment of all the auditory stimuli. Music is part and parcel of the chosen stimuli, as many critics have proved that music was a source of transfer effect for visual and spatial skills for instance (Giomi-Costa, 2003) A synthesis of these researches has been at the source of the so called " method of programmed auditory skills " whose purpose was to develop the complete auditory skills abilities. This complete teaching programme has been integrated in a playful context for children that allows to control the action, the gesture and the game as well as the sounds atmosphere. This teaching programme is controlled by a computer with a large number of different sounds and which is linked to the playful sphere.

The main objective of this survey is to evaluate the efficiency of this auditory teaching programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf children aged from 4 to 10.

This study will take place in the CHU de La Timone in Marseilles in the ENT children department and is at the heart of a cooperation with Dr Emmanuel Bigand team in Dijon (LEAD CNRS, UMR 5022 à Dijon). The cochlear implant children department in Marseilles gathers a group of more than 70 implanted children aged from 4 to 10 that is in adequacy with the parameters for the method to evaluate.

Two groups of 21 cochlear implant children will be included in this study.

This study will be divided into two phases separated by 3 sessions of evaluation tests.

The first session T1 will occur in the two groups (experimentation on G1 and control on G2), then the first training session will start in group G1.

The second session T2 will occur in the two groups, then the first training session will start in group G2.

The third session T3 will occur in the 2 groups at the end of the experiment.

By training the 4 perceptible operations with different auditory stimulations (speech, music, sounds and electro-acoustic sounds), we are looking for better performance in the trained skills as well as a teaching transfer on other linguistic abilities (phonetics discrimination and speech).

Being tested
3 sessions of evaluation tests, 1 training session

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 sessions of evaluation testsOther

    3 sessions of evaluation tests, each session during 15 days

  • 1 training sessionOther

    20 sessions of 30 minutes by week during 24 semaines

Study groups in NCT00947778
Study groupRoleWhat they receive
session of training 1Active comparatorArm from which members will perform their training session after the first session of evaluation
Session of training 2Active comparatorArm from which members will perform their training session after the second session of evaluation
Receives: Other: 3 sessions of evaluation tests; Other: 1 training session

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to evaluate the efficiency of this auditory teaching programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf children.

    Measured: 18 months

Secondary outcomes (1)
  1. to evaluate the efficiency of this auditory teaching programme (MPAA) over the transfer of learning towards tasks of perception and production of the word

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00947778
Sponsor's protocol ID
2009-05
Other IDs
2009-A00343-54
Status last verified
Feb 2014
First submitted
27 Jul 2009
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No

Publications

  • Roman S, Rochette F, Triglia JM, Schon D, Bigand E. Auditory training improves auditory performance in cochlear implanted children. Hear Res. 2016 Jul;337:89-95. doi: 10.1016/j.heares.2016.05.003. Epub 2016 May 27.

    PubMed 27240480

Questions about this trial

What is this clinical trial studying?

A study testing 3 sessions of evaluation tests and 1 training session in people with Children With Cochlear Implant, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

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 2 inclusion and 1 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 7 May 2026. 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 France. 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?

to evaluate the efficiency of this auditory teaching programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf children. (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00947778, which also lists 1 linked publication.

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 7 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in