NCT05670158 Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss
| NCT ID | NCT05670158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Sensorineural Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-07 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-12-07 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05670158 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sensorineural Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05670158 currently recruiting?
Yes, NCT05670158 is actively recruiting participants. Contact the research team at a-kaderbay@chu-montpellier.fr for enrollment information.
Where is the NCT05670158 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT05670158 clinical trial?
NCT05670158 is sponsored by University Hospital, Montpellier. The trial plans to enroll 80 participants.