Actively Recruiting
Study on Inner Ear Immune Response and Perilymph Molecular Profiles in Sensorineural Hearing Loss After Cochlear Implantation
Led by University Hospital, Montpellier · Updated on 2024-01-18
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating sensorineural hearing loss in patients undergoing cochlear implantation. The study aims to identify biomarkers in the inner ear fluid called perilymph and in the blood that may predict delayed loss of residual hearing after implantation. This loss of hearing can occur early due to surgical trauma or later due to immune or inflammatory responses. Understanding these mechanisms could improve treatment and hearing preservation for patients who still have some hearing before surgery. The study involves two groups: 50 patients receiving cochlear implants and 30 control patients with normal hearing undergoing other ear surgeries. Blood samples will be collected from all participants, and perilymph samples will be taken during cochlear implant surgery. The implanted patients will be followed for 12 months with six visits for blood sampling and hearing assessment. Controls will have four visits over six months to provide blood samples during their routine follow-ups. Participants will have blood and perilymph collected at surgery, with additional blood samples taken at 1, 3, 6, and 12 months after implantation. Researchers will measure protein and metabolite levels in perilymph and blood, and count specific immune cells over time. These data will be correlated with hearing outcomes to identify markers of hearing loss. The study includes detailed clinical assessments and aims to build a biobank for future research on hearing preservation and immune responses after cochlear implantation.
CONDITIONS
Brief Title
Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or more
- Severe to profound sensorineural deafness with speech intelligibility of 50% or less (for cochlear implantation group)
- Presence of useful residual hearing (80 dB or better) on at least two consecutive frequencies between 125 and 1000 kHz (for cochlear implantation group)
- Indication for middle ear surgery excluding active infection or inflammation (for control group)
- Normal hearing with average bone conduction threshold 35 dB or less (for control group)
- Free and informed written consent given
- Affiliated to a French social security system
You will not qualify if you...
- Contraindication to surgery identified during preoperative assessment
- Unfavorable cochlear condition for implantation
- Absence of residual hearing shown by preoperative audiometry
- History of bacterial labyrinthitis or bacterial meningitis
- Cochlear ossification on preoperative imaging
- Certain genetic mutations related to hearing loss (if known)
- Vulnerable subjects such as minors, protected adults, pregnant or breastfeeding women, those under guardianship or deprived of liberty
- Participation in another pharmacological interventional clinical trial
- Fluctuating hearing thresholds (for control group)
- Middle ear infection or inflammation on surgery day (for control group)
- Chronic immune or inflammatory disease (for control group)
- Active viral or bacterial infection or fever on day of inclusion or surgery (for control group)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 1 day
Participants undergo cochlear implantation surgery or an alternative otological surgery. During cochlear implantation, perilymph and blood samples are collected. For the control group, blood sampling is performed during surgery.
1 surgery visit (in-person)
Duration - 12 months post-surgery
Participants have blood samples collected at multiple follow-up visits after surgery to monitor immune response and molecular profiles over time.
Visits at 1 month, 3 months, 6 months, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
UH Montpellier
Montpellier, France, 34295
Actively Recruiting
Research Team
A
Akil Kaderbay, MD
F
Frédéric Venail, PhD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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