Investigating immune responses and biomarkers in patients receiving cochlear implants
Study on the Inner Ear Immunisation Post-cohlear Implantation and Perilymph Molecular Profiling in Sensorineural Hearing Loss
This study is trying to understand why some people lose their remaining hearing after getting cochlear implants by looking at their blood and inner ear samples.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05670158 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the mechanisms behind residual hearing loss in patients undergoing cochlear implantation by analyzing perilymph and blood samples. It will recruit 50 candidates for cochlear implantation and 30 control subjects with normal hearing undergoing other otological procedures. The research focuses on identifying predictive biomarkers related to hearing loss and understanding the immune response to cochlear implants using advanced proteomics and immunological techniques. The findings could provide insights into preserving residual hearing post-surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with severe to profound sensorineural hearing loss and some measurable residual hearing.
Not a fit: Patients with active infections or inflammatory conditions affecting the middle ear may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preserving residual hearing in cochlear implant patients.
How similar studies have performed: While there have been studies on cochlear implantation, this specific approach focusing on immune responses and biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- UH Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Akil Kaderbay, MD
- Email: a-kaderbay@chu-montpellier.fr
- Phone: +33467336890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.