Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06499584

Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations

The Functional Role of Cochlear Synaptopathy for Speech Coding in the Brain

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
CHU de Reims · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

In humans, surface electrophysiological recordings of the cochlear nerve in response to a sound stimulus provide information about the cochlear's ability to encode sound. Depending on the stimulus, the fine structure and temporal envelope of the signal will vary, allowing us to determine its characteristics. By phenotyping patients before surgery using subjective and objective audiometric tests, it will be possible to isolate for each patient the moment when the fine structure disappears and when the temporal envelope is effective.

Detailed description

During functional cerebellopontine angle surgery, a spherical electrode is placed on the human cochlear nerve to monitor hearing. Once the electrode is in place, clicks and speech signals with and without noise are delivered to analyze the cochlear electrophysiological signal produced. Depending on the characteristics recorded, this signal can be used to determine how fine structure and temporal envelope are encoded by the cochlea. Prior to surgery, each patient is evaluated by an audiologist to determine quiet and noise thresholds, tone and speech, electrocochleography, distortion testing, tympanometry, ABR and psychoacoustic testing.

Conditions

Interventions

TypeNameDescription
PROCEDUREnear field recording of human auditory nerve activity during retro sigmoid approach with contact electrodeDuring surgery using a retro-sigmoid approach in the cerebellopontine angle (microvascular decompression), near-field recording of human auditory nerve activity using a contact electrode is performed on patients with normal or impaired hearing threshold. Each patient is explored preoperatively by hearing tests. During the surgery, stimuli are delivered.

Timeline

Start date
2023-03-21
Primary completion
2026-12-01
Completion
2027-12-01
First posted
2024-07-12
Last updated
2024-07-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06499584. Inclusion in this directory is not an endorsement.