Understanding cochlear nerve function during surgery for hearing loss
Basic and Clinical Studies of Cochlear Synaptopathy
This study is trying to see how the cochlear nerve works during surgery for hearing loss to help improve our understanding of hearing and nerve function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Trial ID | NCT06556160 on ClinicalTrials.gov |
What this trial studies
This study investigates the functional properties of the cochlear nerve during otoneurosurgery by using near-field electrophysiological recordings. A ball electrode will be placed on the cochlear nerve to monitor responses to sound stimuli, allowing for a detailed analysis of auditory neuron populations. Patients undergoing surgery for microvascular decompression will be assessed for their hearing thresholds prior to the procedure, and the data collected will contribute to a mathematical model of the human cochlea. This approach aims to enhance our understanding of synaptic transmission and nerve fiber function in relation to hearing loss.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with normal hearing or sensorineural hearing loss, who are scheduled for surgery on the cerebellopontine angle.
Not a fit: Patients with profound neuro-sensory deafness or those not undergoing the specified surgical procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for individuals with hearing loss.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding auditory nerve function, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
inclusion criteria : Patients with normal hearing will be included: * male or female * over 18 and up to 70 years of age * normal otoscopic examination * due to undergo surgery on the cerebellopontine angle (microvascular decompression). * free of neuro-sensory deafness, defined by mean hearing thresholds of less than or equal to 20 dB HL in pure tone audiometry in air conduction bilaterally on the side of the ear operated on and on the non-operated side from 0.25 to 8 kHz * affiliated to a social security scheme * have read the information note describing the study and have agreed in writing to take part by signing the informed consent form. Patients with a hearing impairment will be included: * male or female * over 18 and up to 70 years of age * normal otoscopic examination * due to undergo surgery on the cerebellopontine angle (microvascular decompression). * have a sensorineural hearing loss defined by hearing thresholds of 20 dB HL or better from 0.25 to 2 kHz and from 20 dB HL excluded to 55 dB HL at frequencies above 2 kHz. * have read the information note describing the study and have agreed in writing to take part by signing the informed consent form. exclusion criteria : - Patients will be excluded from the study for whom the auditory nerve is not accessible during surgery, in particular because of complete tumour invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma) or because of a particular anatomical feature not identified during the preoperative examination, making it impossible to expose the nerve for recordings (protrusion of the posterior surface of the rock).
Where this trial is running
Reims
- Damien JOLLY — Reims, France (Recruiting)
Study contacts
- Study coordinator: Xavier DUBERNARD
- Email: xdubernard@chu-reims.fr
- Phone: 03 26 78 71 25
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.