Analysis of Language and Auditory Abilities in Cochlear Implanted Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00947778
First received: July 27, 2009
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention
Children With Cochlear Implant
Other: 3 sessions of evaluation tests
Other: 1 training session

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Analysis of Language and Auditory Abilities in Cochlear Implanted Children: Assessment by an Auditory Learning Programmed Method

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: session of training 1
Arm from which members will perform their training session after the first session of evaluation
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
Active Comparator: Session of training 2
Arm from which members will perform their training session after the second session of evaluation
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947778

Locations
France
Assistance Publique-Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Stephane Roman Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00947778     History of Changes
Other Study ID Numbers: 2009-05, 2009-A00343-54
Study First Received: July 27, 2009
Last Updated: February 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on August 26, 2014