Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients (NEUROSYLLABIC)

Civil Hospices of Lyon

Status: Completed

Conditions: Deafness

Treatments: Other: P1-N1-P2 complex and Mismatch Negativity MMN; Other: Acoustic Change Complex ACC; Other: Auditory steady-state response ASSR; Other: Speech-ABR

Study type: Interventional

Funder types: Other

Identifiers

NCT02323256

2014.857

2014-A00345-42 (Other Identifier)

Details and patient eligibility

About

This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.

Enrollment: 91 patients

Sex: All

Ages: 1 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• native French speaker
• no medical treatment for behavior or neurological disorders
• normal or corrected vision
• right-handed
• normal ORL examination
• valid affiliation to social security
• absence of participation to another study

For the cochlear implanted patients:

• aged from 1 to 70
• bilateral severe to profound deafness
• cochlear implant
• congenital deafness, pre or post lingual

For the normal-hearing subjects:

• Aged from 18 to 70
• Normal tonal audiometry

Exclusion criteria

• No signed consent
• Treatment for depression, epilepsy, Parkinson's or Alzheimer's disease
• Physical health deficiency
• Mental retardation
• Neurological or psychiatric disease incompatible with the testing procedure
• Schooling in a foreign language
• Foreign language spoken at home with both parents
• Invalid social security
• For the normal hearing subjects, no known hearing deficits

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 4 patient groups

newly cochlear implanted adult patients

Experimental group

Description:

longitudinal group

Treatment:

Other: Auditory steady-state response ASSR

Other: Speech-ABR

Other: P1-N1-P2 complex and Mismatch Negativity MMN

Other: Acoustic Change Complex ACC

newly cochlear implanted children

Experimental group

Description:

longitudinal group

Treatment:

Other: Auditory steady-state response ASSR

Other: Speech-ABR

Other: P1-N1-P2 complex and Mismatch Negativity MMN

Other: Acoustic Change Complex ACC

cochlear implanted adult patients (CI>1 year)

Active Comparator group

Description:

transversal group

Treatment:

Other: Auditory steady-state response ASSR

Other: Speech-ABR

Other: P1-N1-P2 complex and Mismatch Negativity MMN

Other: Acoustic Change Complex ACC

normal hearing adult subjects

Active Comparator group

Description:

transversal group

Treatment:

Other: Auditory steady-state response ASSR

Other: Speech-ABR

Other: P1-N1-P2 complex and Mismatch Negativity MMN

Other: Acoustic Change Complex ACC