NCT06248398 Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
| NCT ID | NCT06248398 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Severe to Profound Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-02-20 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 with adapted hearing aids. * Patient able to understand the information note and give written consent * Affiliation to a French social security system Exclusion Criteria: * 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 interventional study (Jardé 1) * Patient under legal protection (guardianship or curatorship) or deprived of liberty
Contact & Investigator
Ghizlene LAHLOU, Dr
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06248398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe to Profound Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06248398 currently recruiting?
Yes, NCT06248398 is actively recruiting participants. Contact the research team at ghizlene.lahlou@aphp.fr for enrollment information.
Where is the NCT06248398 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06248398 clinical trial?
NCT06248398 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Ghizlene LAHLOU, Dr at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 140 participants.