Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT05670158
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05670158
Study Brief:
Protocol Section:
NCT05670158