Examining how the cochlea responds to human speech sounds
The Functional Role of Cochlear Synaptopathy for Speech Coding in the Brain
This study is testing how the cochlea responds to human speech sounds during surgery to help understand hearing problems better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Trial ID | NCT06499584 on ClinicalTrials.gov |
What this trial studies
This study investigates the cochlea's ability to encode sound by analyzing its response to human vocalizations during surgery. Using a spherical electrode placed on the cochlear nerve, researchers will monitor the electrophysiological signals produced in response to various sound stimuli, including clicks and speech signals. Patients will undergo thorough audiometric evaluations prior to surgery to assess their hearing capabilities, allowing for a detailed analysis of the cochlea's fine structure and temporal envelope. The goal is to better understand how these characteristics are affected in individuals with hearing impairments compared to those with normal hearing.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 scheduled for cerebellopontine angle surgery with either sensorineural hearing loss or normal hearing.
Not a fit: Patients with profound hearing loss or those not scheduled for cerebellopontine angle surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of cochlear function and improve surgical outcomes for patients with hearing loss.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding cochlear function through electrophysiological recordings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * The following will be included as hearing-impaired patients: * Male or female * Over 18 and up to 80 years of age * Normal otoscopic examination * Scheduled for surgery on the cerebellopontine angle (microvascular decompression) * With sensorineural hearing loss defined by average hearing thresholds between 21 dB HL and 40 dB HL at 0.5, 1, 2 and 4 kHz * Affiliated to a social security scheme * Having read the information note describing the study and having agreed in writing to participate by signing the informed consent form * Will be included as normal-hearing patients: * Male or female * Over 18 and up to 80 years of age * Normal otoscopic examination * Scheduled for surgery on the cerebellopontine angle (microvascular decompression) * Free of sensorineural hearing loss, defined by average hearing thresholds of less than or equal to 20 dB HL in tonal air conduction audiometry, bilaterally on the side of the ear undergoing surgery and on the side not undergoing surgery, at 0.5, 1, 2 and 4 kHz * Affiliated to a social security scheme * Having read the information note describing the study and having agreed in writing to participate by signing the informed consent form Exclusion criteria: patients will be excluded from the study if the auditory nerve is not accessible during surgery: * Notably because of complete tumor 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 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 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.