Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT06556160
Eligibility Criteria:
inclusion criteria :
Patients with normal hearing will be included:
* male or female
* over 18 and up to 70 years of age
* normal otoscopic examination
* due to undergo surgery on the cerebellopontine angle (microvascular decompression).
* free of neuro-sensory deafness, defined by mean hearing thresholds of less than or equal to 20 dB HL in pure tone audiometry in air conduction bilaterally on the side of the ear operated on and on the non-operated side from 0.25 to 8 kHz
* affiliated to a social security scheme
* have read the information note describing the study and have agreed in writing to take part by signing the informed consent form.
Patients with a hearing impairment will be included:
* male or female
* over 18 and up to 70 years of age
* normal otoscopic examination
* due to undergo surgery on the cerebellopontine angle (microvascular decompression).
* have a sensorineural hearing loss defined by hearing thresholds of 20 dB HL or better from 0.25 to 2 kHz and from 20 dB HL excluded to 55 dB HL at frequencies above 2 kHz.
* have read the information note describing the study and have agreed in writing to take part by signing the informed consent form.
exclusion criteria :
\- Patients will be excluded from the study for whom the auditory nerve is not accessible during surgery, in particular because of complete tumour 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 it impossible to expose the nerve for recordings (protrusion of the posterior surface of the rock).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06556160
Study Brief:
Protocol Section:
NCT06556160