Interest of the Bilateral Cochlear Implantation in the Deep Deaf Children Respect to the Unilateral Implantation - a Randomized Test
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Primary Endpoint
- Measurement of the score of perception of words in open list
Study Overview
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.
Detailed Description
French multicentric study. 100 children, profound, congenitally deaf, aged between 10 months and 40 months, with indication of unilateral CI will be included. Randomization: 50 sequential at one year CI versus 50 simultaneous bilateral CI, their results compared. Main measures at 12 and 24 months: speech perception in silence and in noise. Other measures: sound localisation, oral language, vestibular impact, quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Months to 38 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
sequential
implantation bilateral sequential
Intervention: bilateral cochlear Implantation in sequential (Procedure)
simultaneous
implantation bilateral simultaneous
Intervention: bilateral cochlear Implantation in simultaneous (Procedure)
Outcomes
Primary Outcomes
Measurement of the score of perception of words in open list
Time Frame: 12 months after the implantation
Measurement of the score of perception of words in open list in the noise 12 and 24 months after the implantation
Secondary Outcomes
- 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)