Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children (Cochleo)

Assistance Publique - Hôpitaux de Paris

Status and phase: Withdrawn; Phase 3

Conditions: Deafness

Treatments: Procedure: bilateral cochlear Implantation in simultaneous; Procedure: bilateral cochlear Implantation in sequential

Study type: Interventional

Funder types: Other

Identifiers

NCT01499901

P091204

HAO 09048 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 8 to 38 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

sequential

Experimental group

Description:

implantation bilateral sequential

Treatment:

Procedure: bilateral cochlear Implantation in sequential

simultaneous

Experimental group

Description:

implantation bilateral simultaneous

Treatment:

Procedure: bilateral cochlear Implantation in simultaneous