Establish a Concordance Between the Mismatch Negativity Amplitude and a Score of Logatoms Discrim… (NCT03025386) | Clinical Trial Compass
TerminatedNot Applicable
Establish a Concordance Between the Mismatch Negativity Amplitude and a Score of Logatoms Discrimination
Stopped: inclusions stopped
France40 participantsStarted 2017-05-18
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Aged from 18 to 75
* Severe to profound deafness
* Cochlear implant user for over a year
* Affiliation or beneficiary of the social insurance
Exclusion criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between MMN amplitude and logatoms discrimination score in the discrimination capacity