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New treatment option for Severe to Profound Hearing Loss
Official title Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
ClinicalTrials.gov ID: NCT06248398
What this study is testing
- What it's testing
- The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment. To do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery).
- Time commitment: about 17 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patient ≥ 18 years old
- Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with...
- Patient able to understand the information note and give written consent
- Affiliation to a French social security system
You likely can't join if
- Patient who does not speak French
- Etiologies of deafness known to be of bad prognosis (auditory neuropathy, congenital profound deafness, immediate post-meningitis profound deafness...
- Impossibility of testing the effect of the cochlear implant alone on hearing results (cochlear implantation in the context of unilateral deafness or...
- Cochlear implantation requiring the use of a perimodiolar electrode holder.
- Pregnant and breastfeeding women
- Patients wearing electronic devices, in direct connection with the brain or nervous system
See the full eligibility criteria
- Adult patient ≥ 18 years old
- Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with intelligibility ≤70% for Fournier dissyllabic words, in free field, at 60dB...
- Patient able to understand the information note and give written consent
- Affiliation to a French social security system
- Patient who does not speak French
- Etiologies of deafness known to be of bad prognosis (auditory neuropathy, congenital profound deafness, immediate post-meningitis profound deafness, vestibular schwannoma on the side of the ear to be implanted)
- Impossibility of testing the effect of the cochlear implant alone on hearing results (cochlear implantation in the context of unilateral deafness or fluctuating deafness)
- Cochlear implantation requiring the use of a perimodiolar electrode holder.
- Pregnant and breastfeeding women
- Patients wearing electronic devices, in direct connection with the brain or nervous system
- Patient included in another treatment study (Jardé 1)
- Patient under legal protection (guardianship or curatorship) or deprived of liberty
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 17 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.