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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode | During 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.