Study Stopped
Recommendations of HAS have changed, the study is now useless
Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children
Cochleo
Interest of the Bilateral Cochlear Implantation in the Deep Deaf Children Respect to the Unilateral Implantation - a Randomized Test
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The impact on perception and language of bilateral CI simultaneous versus sequential has to be established before discussing the enlargement of indications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
December 26, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedNovember 19, 2012
November 1, 2012
Same day
December 6, 2011
November 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of the score of perception of words in open list
Measurement of the score of perception of words in open list in the noise 12 and 24 months after the implantation
12 months after the implantation
Secondary Outcomes (5)
Measurement of the capability of localization right/left
12 and 24 months after the implantation
Measurement of the level of comprehension and production
24 months after the implantation
Evaluation of the medical monitoring about the materiovigilance and the eventual complications
During all the duration of the study
Measurement of the vestibulometry and of the children's psychomotor development
12 and 24 months after the implantation
Analysis of the parent questionnaires of the quality of life
12 and 24 months after implantation
Study Arms (2)
sequential
EXPERIMENTALimplantation bilateral sequential
simultaneous
EXPERIMENTALimplantation bilateral simultaneous
Interventions
bilateral cochlear Implantation in sequential
bilateral cochlear Implantation in simultaneous
Eligibility Criteria
You may qualify if:
- Deep bilateral congenital deafness.
- Age at the implantation: from 10 to 40 months, included.
- Criteria for indication of unilateral implantation (those considered by the HAS (2007))
- Deep bilateral deafness
- Threshold prosthetic equal or above 60 dB
- Intelligibility test in open list, below 30%, (to children under 3 years old : raw score in the questionnaire of the M.A.I.S. (72) below 15 with 2 apparatus)
- No medical nor radiologic contraindication
- Entitled child for welfare (excepted medical state aids)
- French spoken at home
- Agreement firms for the study by the two genitors
You may not qualify if:
- Neurologic and/or psychiatric known related disorders
- Malformation of the inner ear: the MRI scanners are routine examinations, in case of a cochlear implantation evaluation.
- Progressive or acquired deafness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathalie Loundon, MD, MD-PhD
Assistance Publique
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2011
First Posted
December 26, 2011
Study Start
January 1, 2012
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
November 19, 2012
Record last verified: 2012-11