Impact of Robotic Cochlear Implantation on Hearing Performance in Noise

NCT06248398 | Recruiting

• 2 other identifiers: APHP2113302023-A00837-38
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe to Profound Hearing Loss

Keywords

Cochlear implant; Manual insertion; Robotic assistance insertion; Hearing understanding in noise; Quality of life

Outcome Measures

Primary Outcomes (1)

• Auditory performance in noise with the cochlear implant

  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

  At 6 months post-implantation

Secondary Outcomes (12)

• Hearing performance in noise after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes

  At 3 and 6 months post-implantation

• Hearing performance in noise under ecological conditions after robotic cochlear implantation compared to conventional manual cochlear implantation

  At 3 and 6 months post-implantation

• Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for words

  At 3 and 6 months post-implantation

• Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes

  At 3 and 6 months post-implantation

• The subjective benefit on tinnitus after robotic cochlear implantation compared to conventional manual cochlear implantation

  At 3 and 6 months post-implantation

Study Arms (2)

Experimental arm

EXPERIMENTAL

Patient having cochlear implantation surgery with RobOtol®.

Procedure: Surgery with RobOtol®

Control arm

OTHER

Patient having conventional manual cochlear implantation surgery.

Procedure: Conventional manual surgery

Interventions

Surgery with RobOtol® PROCEDURE

Patient having cochlear implantation surgery with RobOtol®.

Experimental arm

Conventional manual surgery PROCEDURE

Patient having conventional manual cochlear implantation surgery

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Ghizlene LAHLOU, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghizlene LAHLOU, Dr

CONTACT

01 42 16 26 10; ghizlene.lahlou@aphp.fr

Isabelle MOSNIER, Dr

CONTACT

01 42 16 26 10; isabelle.mosnier@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: February 8, 2024
• Study Start: February 20, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)