Analysis of Language and Auditory Abilities in Cochlear Implanted Children

Tracking Information
First Submitted Date ICMJE	July 27, 2009
First Posted Date ICMJE	July 28, 2009
Last Update Posted Date	February 25, 2014
Study Start Date ICMJE	July 2009
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 27, 2009)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00947778 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 27, 2009)	to evaluate the efficiency of this auditory teaching programme (MPAA) over the transfer of learning towards tasks of perception and production of the word [ Time Frame: 18 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Analysis of Language and Auditory Abilities in Cochlear Implanted Children
Official Title ICMJE	Analysis of Language and Auditory Abilities in Cochlear Implanted Children: Assessment by an Auditory Learning Programmed Method
Brief 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. 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. 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).
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).
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)
Condition ICMJE	Children With Cochlear Implant
Intervention ICMJE	Other: 3 sessions of evaluation tests 3 sessions of evaluation tests, each session during 15 days; Other: 1 training session 20 sessions of 30 minutes by week during 24 semaines
Study Arms	Active Comparator: session of training 1 Arm from which members will perform their training session after the first session of evaluation Interventions: Other: 3 sessions of evaluation tests Other: 1 training session; Active Comparator: Session of training 2 Arm from which members will perform their training session after the second session of evaluation Interventions: Other: 3 sessions of evaluation tests Other: 1 training session
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 24, 2014)	22
Original Estimated Enrollment ICMJE; (submitted: July 27, 2009)	42
Actual Study Completion Date	November 2010
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: children with congenital deaf to speak; children with cochlear implant Nucleus Exclusion Criteria: children unable to understand orders in the oral or in the language of signs
Sex/Gender	Sexes Eligible for Study: All
Ages	4 Years to 10 Years (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00947778
Other Study ID Numbers ICMJE	2009-05; 2009-A00343-54
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Assistance Publique Hopitaux De Marseille
Study Sponsor ICMJE	Assistance Publique Hopitaux De Marseille
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Stephane Roman Assistance Publique Hopitaux De Marseille
PRS Account	Assistance Publique Hopitaux De Marseille
Verification Date	February 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP