Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hea
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 o
| Condition(s) | Sensorineural Hearing Loss |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 * In |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Montpellier |
| Locations | Montpellier, France |
| Start date | 2023-12-07 |
| NCT ID | NCT05670158 |
| Official listing | https://clinicaltrials.gov/study/NCT05670158 |