Investigating immune responses and biomarkers in patients receiving cochlear implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UH Montpellier
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Akil Kaderbay, MD
• Email: a-kaderbay@chu-montpellier.fr
• Phone: +33467336890

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.