Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients (NCT02323256) | Clinical Trial Compass
CompletedNot Applicable
Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
France91 participantsStarted 2014-07
Plain-language summary
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.
Who can participate
Age range
1 Year – 70 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:
* 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
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
Amplitude of auditory steady state responses ASSR
Timeframe: one year at least after CI activation
2
Spectro-temporal analysis of speech-ABR
Timeframe: one year at least after CI activation
3
Acoustic Change Complex ACC
Timeframe: one year at least after CI activation
4
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Timeframe: one year at least after CI activation
5
Evolution of amplitude of auditory steady state responses ASSR
Timeframe: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
6
Evolution of spectro-temporal analysis of speech-ABR
Timeframe: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
7
Acoustic Change Complex ACC
Timeframe: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation