Ignite Creation Date:
2024-07-17 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499584
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-06
Brief Title:
Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
The Functional Role of Cochlear Synaptopathy for Speech Coding in the Brain
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CosySpeech
Brief Summary:
In humans surface electrophysiological recordings of the cochlear nerve in response to a sound stimulus provide information about the cochlears 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None