Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss

Summary

Many patients receiving cochlear implant (CI) have some residual hearing prior to implantation surgery. However, approximately one third of them will lose it in next 6 months after cochlear implantation. Although the mechanisms involved in the residual audition loss remain unknown, animal experiments suggest the role of inflammatory or immune reaction in the cochlea. The goal of this project is to search in the perilymph (a fluid which fills the scala vestibuli and scala tympani of the cochlea) some predictive biomarkers of the residual hearing loss using modern proteomics and immunological techniques. A parallel search for blood biomarkers of post-implantation residual hearing loss and for molecular and cellular evidences of immune response to cochlear implantation will be performed.

The study will recruit 50 subjects-candidates for cochlear implantation surgery; 30 normally hearing individuals eligible for other types of otological interventions will form a control group. For all the participants blood samples will be collected and preserved. In addition, the perilymph sampling will be performed during cochlear implantation surgery.

This project relies on the calculation that from 50 patients post-cochlear implantation, 15 patients will form a group with maintained residual hearing and 15 will display delayed hearing loss. For these 30 subjects together with the control group the blood biomarkers search will be performed.

For the group of implanted patients, the follow-up will last for 12 months with 6 visits in total :

* the inclusion visit V0 during which the study will be presented and the consent form will be signed
* the surgery visit V1 with blood sample and perilymph collection
* the activation visit V2, 1 month ± 1 week after V1, visit V3 3 months ± 7 days after V1, V4 6 months ± 7 days after V1, V5 12 months ± 1 month after V1. During each of this visit blood sampling will be performed.

For the control group, the follow up will be 6 months long with 4 visits in total arranged during the routine follow-up appointments:

* the inclusion visit V0 during which the study will be presented and the consent form will be signed
* the surgery visit V1, the 1 month visit V2 and the 6 months visit V3 during which the blood sampling will be performed.

Conditions

• Sensorineural Hearing Loss

Interventions

BIOLOGICAL

Blood sampling

Blood will be collected into 2 EDTA and 1 heparin tube. The 2 EDTA tubes (4ml of blood in each) will be transported on ice to the proteomics platform in the next three hours, centrifuged and stored on -80 degrees Celcius in low-binding tubes for further molecular analysis. 1 heparin tube (5mL) will be sent to the Bacteriology-Virology Department for the active PBMC counting.

PROCEDURE

Perilymph sampling

The perilymph collection will be performed during the cochlear implantation surgery at the same time as the round window opening. 5 to 15 microliters will be aspirated using an atraumatic spinal needle mounted onto 1 ml insulin syringe.

Sponsors & Collaborators

• University Hospital, Montpellier

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-07

Primary Completion

2026-03-31

Completion

2027-03-31

Countries

• France

Study Locations