CompletedNot Applicable

Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

France17 participantsStarted 2013-03-04

Plain-language summary

Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.

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: * Subject of French language * Subject with a moderate bilateral sensorineural hearing loss, severe to profound * Sensorineural hearing loss post-lingual (after onset of language acquisition) * Subject paired with the implant Neurelec (Appendix 1) for more than 9 months * Subject has received an appropriate setting under usual clinical follow-up * Elderly 18 to 75 years * Subject giving consent Exclusion Criteria: * Sensorineural hearing loss pre-lingual * Deafness following a meningitis, or neurodegenerative diseases * Illiteracy * Pregnant women * Subject blind * Subject enjoying a measure of legal protection * Subject incapable of giving consent * Subject vulnerable

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

Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.

Timeframe: At the inclusion - Day 0

Trial details

NCT IDNCT01805167

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09-30

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