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Clinical Trials in France / NCT06248398
Recruiting Not applicable

Impact of Robotic Cochlear Implantation on Hearing Performance in Noise

NCT06248398 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2024-02-20
Last updated
2025-02-17

Condition(s) studied

Severe to Profound Hearing Loss

Investigational drug(s) / intervention(s)

Surgery with RobOtol®Conventional manual surgery

Surgery with RobOtol®: Patient having cochlear implantation surgery with RobOtol®.

Conventional manual surgery: Patient having conventional manual cochlear implantation surgery

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Auditory performance in noise with the cochlear implant — At 6 months post-implantation
    Evolution of the intelligibility score (Variation of the percentage of words understood) for monosyllabic Lafon words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 6 months post-implantation

Trial sites (1)

FacilityCityRegionStatus
Groupe Hospitalier Pitié-Salpêtrière Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06248398 on ClinicalTrials.gov ↗ ← All trials in France