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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Jan 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying why some patients lose their remaining hearing after getting a cochlear implant, a device that helps people with severe to profound hearing loss. The researchers want to look for signs in a special fluid around the cochlea (the part of the ear that helps with hearing) and in blood samples to see if they can predict which patients might experience this loss. They will recruit 50 adults who need cochlear implants and compare them to 30 individuals with normal hearing who are having other ear surgeries.

To participate in the trial, you must be at least 18 years old and meet specific hearing loss criteria. If you join, you will have several visits over 12 months where blood samples will be taken, and if you're in the cochlear implant group, a fluid sample will be collected during the surgery. The study aims to gather information that could help doctors understand hearing loss better and possibly improve outcomes for future cochlear implant patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for the "Cochlear implantation" group :
• • Patients aged 18 years or more
• • Indication for the cochlear implantation surgery according to the criteria of French National Authority for Health (Severe to profound sensorineural deafness with indication for cochlear implant surgery: Intelligibility less than or equal to 50% when performing vocal audiometry tests with Fournier's list in free field with recent devices.)
• • Presence of "useful" residual hearing ≤ 80 dB on at least 2 consecutive frequencies (in air conduction) from the range 125, 250, 500, 1000 kHz on pure-tone audiometry
• • Patients given their free and informed written consent
• • Patients affiliated to a French social security system
• Inclusion Criteria for the "Control" group:
• • Patients aged 18 years or more
• • Indication for otological surgery of the middle ear (excluding active infectious or inflammatory pathology e.g. myringoplasty, ossiculoplasty, cure for otosclerosis)
• • Normal hearing (non affected inner ear): average hearing loss (mean threshold for the frequencies 500, 1000, 2000, 4000 Hz) ≤ 35 dB in bone conduction
• • Patients given their free and informed written consent
• • Patients affiliated to a French social security system
• Exclusion Criteria for the "Cochlear implantation" group:
• • Contraindication to surgery detected during the preoperative assessment
• • Pre-implantation cochlear assessment unfavorable to the implantation surgery
• • Absence of residual hearing shown by preoperative audiometry
• • History of bacterial labyrinthitis or bacterial meningitis
• • Cochlear ossification shown on preoperative imaging
• • Homozygous pathogenic mutations identified by molecular diagnosis of the SCL26A5 (prestin), TECTB (Beta-Tectorin) genes, and heterozygous of the COCH gene (Cochlin) prior to implantation (if available)
• • Vulnerable subject: minors, protected adults as defined by the Public Health Code, pregnant or breastfeeding women, subject under guardianship or subject deprived of liberty
• • Participation in another pharmacological therapeutic interventional clinical research
• Exclusion Criteria for the Control group:
• • Contraindication to surgery detected during the preoperative assessment
• • Fluctuating hearing = fluctuating hearing thresholds on at least one ear (shown by past bone conduction pure-tone audiometries)
• • History of bacterial labyrinthitis or bacterial meningitis
• • Middle ear infection or inflammation on the day of the surgery
• • Chronical immune or inflammatory disease
• • Active viral or bacterial infection on the day of inclusion visit or surgery
• • Fever on the day of the first blood sample
• • Vulnerable subject: minors, protected adults as defined by the Public Health Code, pregnant or breastfeeding women, subject under guardianship or subject deprived of liberty
• • Participation in another pharmacological therapeutic interventional clinical research