CompletedNot Applicable

Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults

France43 participantsStarted 2010-03-17

Plain-language summary

The primary objective to this study is to describe bilateral auditory information processing in profoundly deaf patients with bilateral cochlear implants compared with normal hearing patients. Assumption used is that due to the central consequences of bilateral deafness on binaural auditory information central processing, time between activation of the two cochlear implants is a decisive factor in bilateral implantation compared to unilateral implantation

Who can participate

Age range

18 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 for patients: \- profoundly deaf patients with bilateral cochlear implants Exclusion criteria for patients: * post-operative complications * incomplete surgical insertion of one of the cochlear implant * age under 18 years * non-compliant patient * pregnant woman or woman with no efficient contraception method * informed consent not signed * no health insurance Inclusion criteria for control \- normal hearing subjects Exclusion criteria control * normal hearing subject * subject under 18 years old * unilateral or bilateral hearing loss * non-compliant subject * pregnant woman or woman with no efficient contraception method * informed consent not signed * no health insurance

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

Cortical brain activation pattern

Timeframe: 6 months

Trial details

NCT IDNCT02904187

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03-22

View on ClinicalTrials.gov More Deafness trials