Examining how the cochlea responds to human speech sounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the cochlea's ability to encode sound by analyzing its response to human vocalizations during surgery. Using a spherical electrode placed on the cochlear nerve, researchers will monitor the electrophysiological signals produced in response to various sound stimuli, including clicks and speech signals. Patients will undergo thorough audiometric evaluations prior to surgery to assess their hearing capabilities, allowing for a detailed analysis of the cochlea's fine structure and temporal envelope. The goal is to better understand how these characteristics are affected in individuals with hearing impairments compared to those with normal hearing.

Why it matters

Who can join: the full rules

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).

Where it's running

• Damien JOLLY
  Reims, France Recruiting

Study contacts

• Study coordinator: Xavier DUBERNARD
• Email: xdubernard@chu-reims.fr
• Phone: 03 26 78 71 25

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.