Establish a Concordance Between the Mismatch Negativity Amplitude and a Score of Logatoms Discrimination

NCT03025386 | Terminated

• 1 other identifier: RECHMPL16_0196
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A cochlear implant is a device for the rehabilitation of severe to profound hearing loss. Despite the standardization of surgical procedures and rehabilitation, speech discrimination performance varied significantly in cochlear implant users and could be improved by early individualized cares. However, there is no objective method yet to evaluate phonemes discrimination, especially in infants, which account for more than half of the indications for implantation. In electroencephalography (EEG), it is possible to highlight the discrimination of auditory stimuli studying the wave of MisMatch Negativity (MMN). In this work, this study propose to use the MMN as an objective vocal audiometry method to evaluate the ability to discriminate phonemes, the smallest units of oral language, in adult cochlear implant users.

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (1)

• Correlation between MMN amplitude and logatoms discrimination score in the discrimination capacity

  The discrimination capacity (positive/ negative) defined by an MMN amplitude above a threshold will be estimated using a ROC curve based on the logatoms discrimination scores The discrimination capacity defined by logatoms test will be positive if the discrimination score is higher or equal to 80%.

  30 days

Secondary Outcomes (1)

• Correlation between MMN amplitude and the Phonetically Balanced Kindergarten score and Vocoder test

  within the first 30 days after the first visit

Study Arms (1)

Adult cochlear implant users

OTHER

Evaluation of a concordance between the mismatch negativity amplitude mesured by electroencephalography and the capacity of logatoms discrimination by using a logatoms test

Other: logatoms test; Other: Electroencephalography

Interventions

logatoms test OTHER

A forced choice test will evaluate the discrimination of the most confusing logatoms in the cochlear implant users, and representative of the French language.

Adult cochlear implant users

Electroencephalography OTHER

Mesure of the mismatch negativity wave

Adult cochlear implant users

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 18 to 75
• Severe to profound deafness
• Cochlear implant user for over a year
• Affiliation or beneficiary of the social insurance

You may not qualify if:

• Phonetically balanced kindergarten score less than 25%
• No steady setting
• Contralateral hearing aid
• Electroacoustic stimulation device or bilateral cochlear implant user
• Inactive electrodes \> 3
• Cochlear Implant wore less than 7 hours per day
• Disorders of memory, attention or executive functions
• Associated disorders with deafness
• No informed consent
• Patient participating in other biomedical research
• Patient who has undergone cochlear reimplantation or brain surgery
• Withdrawal of consents
• Patient lost to follow-up
• Death

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34000, France

Location

Study Officials

• Frédéric VENAIL, PH

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 19, 2017
• Study Start: May 18, 2017
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: September 30, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)