Impact of Robotic Cochlear Implantation on Hearing Performance in Noise

NCT ID: NCT06248398

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2025-12-31

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.

Detailed Description

In the case of severe (70 to 90dB loss) and profound (>90dB loss) hearing loss, when conventional hearing aids no longer provide sufficient benefit, cochlear implantation remains the only possible solution for hearing rehabilitation. In implanted patients, a clear improvement in communication in silence is observed, but almost all patients have difficulty understanding speech in noisy environments. Cochlear implantation involves inserting an electrode holder into the cochlea during a surgical procedure under general anesthesia. The insertion of the electrode holder must be as minimally traumatic as possible in order to preserve the cochlear structures and avoid post-operative fibrosis that could impact the auditory outcomes.

The conventional method of this surgery is the manual insertion of the electrode holder. In recent years, robotic assistance, the RobOtol®, has been developed with the aim of avoiding the jerks of the surgeon's hand and improving the precision of the insertion. RobOtol® has had its CE marking since 2016 and is used in several hospitals in France and abroad.

Conditions

Severe to Profound Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Experimental arm

Patient having cochlear implantation surgery with RobOtol®.

Group Type: EXPERIMENTAL

Surgery with RobOtol®

Intervention Type: PROCEDURE

Patient having cochlear implantation surgery with RobOtol®.

Control arm

Patient having conventional manual cochlear implantation surgery.

Group Type: OTHER

Conventional manual surgery

Intervention Type: PROCEDURE

Patient having conventional manual cochlear implantation surgery

Interventions

Surgery with RobOtol®

Patient having cochlear implantation surgery with RobOtol®.

Intervention Type: PROCEDURE

Conventional manual surgery

Patient having conventional manual cochlear implantation surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ghizlene LAHLOU, Dr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Groupe Hospitalier Pitié-Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Ghizlene LAHLOU, Dr

Role: CONTACT

ghizlene.lahlou@aphp.fr

01 42 16 26 10

Isabelle MOSNIER, Dr

Role: CONTACT

isabelle.mosnier@aphp.fr

01 42 16 26 10

Facility Contacts

Ghizlene LAHLOU, Dr

Role: primary

ghizlene.lahlou@aphp.fr

01 42 16 31 67

Other Identifiers

2023-A00837-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP211330

Identifier Type: -

Identifier Source: org_study_id