Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556160
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-08-17
Brief Title:
Fundamental and Clinical Study of Cochlear Synaptopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Basic and Clinical Studies of Cochlear Synaptopathy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FunCoSy
Brief Summary:
In humans surface electrophysiological recording of the cochlear nerve in response to a sound stimulus provides information about the integrity and function of synapses synaptic transmission and nerve fibre function However this information remains global The investigators have preliminary data showing that it is possible to extract and characterise the functional properties of nerve fibres during otoneurosurgery in humans and therefore to isolate the neuronal sub-populations mentioned above more precisely than is currently possible The use of these electrophysiological data from near-field recordings ie in contact with the nerve will enable the design and improvement of a mathematical model of the human cochlea This model will provide access to the individual responses of each nerve fibre and fill the current gap in knowledge between the functioning of these fibres and global surface recordings
Detailed Description:
During functional surgery on the cerebellopontine angle a ball electrode is placed on the human cochlear nerve to monitor hearing Once the electrode is in place clicks and random noise bands will be delivered in order to analyze the cochlear electrophysiological signal produced Depending on the characteristics recorded this signal can be used at a given frequency and intensity to identify the populations of auditory neurons mainly involved Prior to surgery each patient will have been examined by the audiologist in order to determine the auditory thresholds in silence and noise in tone and in speech to carry out the digit test and to perform an electrocochleography and distortion products Each result analyzed will be the subject of a further analysis using the mathematic model of the human cochlea
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None