Investigating auditory nerve activity in patients with hearing loss
Coding of Speech Signals in the Human Auditory Nerve - an Exploratory Study
This study is testing how well the nerves that help us hear work in people with hearing loss, especially in noisy situations, to better understand their hearing challenges.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Trial ID | NCT06490237 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the function of auditory neurons in humans with hearing loss, particularly in challenging environments with noise. By performing electrophysiological recordings directly on the cochlear nerve during posterior fossa surgery, researchers will assess spontaneous and sound-evoked auditory nerve activity. The study will compare clinical and electrophysiological data to enhance understanding of hearing coding in both normal and hearing-impaired individuals under different auditory conditions. This prospective longitudinal study will utilize stimuli similar to those used in preoperative assessments.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with mild to severe sensorineural hearing loss who are undergoing surgery on the cerebellopontine angle.
Not a fit: Patients with normal hearing or those not undergoing relevant surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved hearing aid technology and strategies for individuals with hearing loss, especially in noisy environments.
How similar studies have performed: While the approach of directly recording auditory nerve activity is innovative, similar studies have shown promise in understanding auditory processing in hearing loss.
Eligibility criteria
Show full inclusion / exclusion criteria
inclusion criteria : Will be included as hearing impaired patients: * male or female * over 18 years of age * who are to undergo surgery on the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor) * with a mild to severe sensorineural hearing loss defined by an average hearing loss (average of thresholds obtained at 500, 1000, 2000 and 4000 Hz) greater than 20 dB and less than 90 dB in pure tone bone conduction audiometry on the side of the operated ear. * affiliated to a social security system. * have read the information note describing the study and have agreed in writing to participate by signing the informed consent form. Will be included as normal hearing patients: * male or female * over 18 years of age * who are to undergo surgery in the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor) * free of neuro-sensory deafness, defined by average hearing thresholds less than or equal to 20 dB in tonal bone conduction audiometry on the side of the operated ear * affiliated with a social security system. * having read the information note describing the study and having agreed in writing to participate by signing the informed consent form. exclusion criteria : Patients for whom the auditory nerve is not accessible during surgery, * because of a complete tumor invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma) * because of an anatomical feature not identified during the preoperative examination, making its exposure for recordings impossible (protrusion of the posterior face 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: 03.26.78.68.92
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.