Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06499584

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

Led by CHU de Reims · Updated on 2024-07-12

20

Participants Needed

1

Research Sites

245 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female
  • Aged between 18 and 80 years
  • Normal otoscopic examination
  • Scheduled for cerebellopontine angle surgery (microvascular decompression)
  • Sensorineural hearing loss with average thresholds between 21 and 40 dB HL at 0.5, 1, 2, and 4 kHz (for hearing-impaired group)
  • Normal hearing with thresholds less than or equal to 20 dB HL bilaterally at 0.5, 1, 2, and 4 kHz (for normal-hearing group)
  • Affiliated to a social security scheme
  • Provided written informed consent after reading study information
Not Eligible

You will not qualify if you...

  • Auditory nerve not accessible during surgery
  • Complete tumor invasion of the cochlear nerve (stage III or IV neuroma, advanced meningioma)
  • Anatomical features preventing nerve exposure for recordings not identified preoperatively (e.g., protrusion of posterior face of the rock)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Damien JOLLY

Reims, France

Actively Recruiting

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Research Team

X

Xavier DUBERNARD

CONTACT

M

Marc LABROUSSE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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