Actively Recruiting
Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-02-17
140
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients/year). Patient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.
CONDITIONS
Official Title
Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient 18 years or older
- Candidates for uni or bilateral, simultaneous or sequential cochlear implantation
- Severe to profound bilateral deafness with speech intelligibility 40% or less for Fournier dissyllabic words at 60dB with adapted hearing aids
- Able to understand study information and provide written consent
- Affiliated with a French social security system
You will not qualify if you...
- Non-French speaking patients
- Deafness types with poor prognosis such as auditory neuropathy, congenital profound deafness, post-meningitis profound deafness, or vestibular schwannoma on the implantation side
- Unable to test cochlear implant effect alone due to unilateral or fluctuating deafness
- Cochlear implantation requiring perimodiolar electrode holder
- Pregnant or breastfeeding women
- Patients with electronic devices connected directly to brain or nervous system
- Participation in another interventional study
- Patients under legal protection or deprived of liberty
AI-Screening
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Trial Site Locations
Total: 1 location
1
Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
G
Ghizlene LAHLOU, Dr
CONTACT
I
Isabelle MOSNIER, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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