Status:
RECRUITING
Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations
Lead Sponsor:
CHU de Reims
Conditions:
Structure Cochlea
Temporal Envelope Cochlea
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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, th...
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 wit...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
March 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06499584
Start Date
March 21 2023
End Date
December 1 2027
Last Update
July 12 2024
Active Locations (1)
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1
Damien JOLLY
Reims, France