Investigating auditory nerve activity in patients with hearing loss

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 aims to evaluate the function of auditory neurons in humans with hearing loss, particularly in challenging environments with noise. By performing electrophysiological recordings directly on the cochlear nerve during posterior fossa surgery, researchers will assess spontaneous and sound-evoked auditory nerve activity. The study will compare clinical and electrophysiological data to enhance understanding of hearing coding in both normal and hearing-impaired individuals under different auditory conditions. This prospective longitudinal study will utilize stimuli similar to those used in preoperative assessments.

Why it matters

Who can join: the full rules

inclusion criteria :

Will be included as hearing impaired patients:

* male or female
* over 18 years of age
* who are to undergo surgery on the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor)
* with a mild to severe sensorineural hearing loss defined by an average hearing loss (average of thresholds obtained at 500, 1000, 2000 and 4000 Hz) greater than 20 dB and less than 90 dB in pure tone bone conduction audiometry on the side of the operated ear.
* affiliated to a social security system.
* have read the information note describing the study and have agreed in writing to participate by signing the informed consent form.

Will be included as normal hearing patients:

* male or female
* over 18 years of age
* who are to undergo surgery in the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor)
* free of neuro-sensory deafness, defined by average hearing thresholds less than or equal to 20 dB in tonal bone conduction audiometry on the side of the operated ear
* affiliated with a social security system.
* having read the information note describing the study and having agreed in writing to participate by signing the informed consent form.

exclusion criteria :

Patients for whom the auditory nerve is not accessible during surgery,

* because of a complete tumor invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma)
* because of an 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: 03.26.78.68.92

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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.