Comparing robotic and manual cochlear implantation for hearing in noise
Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
NA · Assistance Publique - Hôpitaux de Paris · NCT06248398
This study is testing whether robotic-assisted cochlear implants can help people with severe hearing loss hear better in noisy places compared to traditional manual implants.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06248398 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of robotic-assisted cochlear implantation versus conventional manual insertion in patients with severe to profound hearing loss. A total of 140 patients will be randomized into two groups, with 70 receiving robot-assisted surgery and 70 undergoing manual surgery. Participants will be evaluated preoperatively and at 3 and 6 months post-activation of the cochlear implant, focusing on hearing performance in noisy environments and overall quality of life. The study will take place at the Pitié-Salpêtrière hospital in Paris over a period of 17 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe to profound bilateral deafness who have not benefited from hearing aids.
Not a fit: Patients with specific types of deafness known to have poor prognoses or those who do not speak French may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hearing performance in noisy environments for cochlear implant recipients.
How similar studies have performed: While robotic assistance in surgery is a growing field, this specific comparison of robotic versus manual cochlear implantation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Groupe Hospitalier Pitié-Salpêtrière — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Ghizlene LAHLOU, Dr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Ghizlene LAHLOU, Dr
- Email: ghizlene.lahlou@aphp.fr
- Phone: 01 42 16 26 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Severe to Profound Hearing Loss, Cochlear implant, Manual insertion, Robotic assistance insertion, Hearing understanding in noise, Quality of life