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New treatment option for Sensorineural Hearing Loss
Official title Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss
ClinicalTrials.gov ID: NCT05670158
What this study is testing
What is Blood sampling?
Blood sampling is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for sensorineural hearing loss.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Patients given their free and informed written consent
You likely can't join if
- 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
See the full eligibility 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...
- 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 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
- 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 treatment 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 treatment clinical research
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.