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Search / Trial NCT06499584

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

Launched by CHU DE REIMS · Jul 11, 2024

Trial Information

Current as of November 13, 2025

Recruiting

Keywords

Hearing Loss Deafness Micro Vascular Decompression Otoneurosurgery Retrosigmoid Approach

ClinConnect Summary

This clinical trial is looking at how the cochlea, a part of the inner ear that helps us hear, responds to human voices. Researchers want to understand the details of how sound is processed in the cochlea when people hear different types of sounds. By studying patients before they have surgery on a specific part of the brain, they hope to find out when certain sound details can be detected and when they fade away. This information could help improve treatments for hearing loss.

To be eligible for the study, participants must be between 18 and 80 years old and scheduled for surgery on the cerebellopontine angle, which is near the ear. They can either have some hearing loss or be normal-hearing individuals, as long as they meet specific hearing tests. Participants will need to give their consent after reading about the study, and those selected will have their hearing assessed during the process. It’s important to note that individuals with certain types of tumors or specific anatomical issues that prevent access to the auditory nerve during surgery won’t be able to participate.

Gender

ALL

Eligibility criteria

  • 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).

About Chu De Reims

Chu de Reims, or the University Hospital of Reims, is a leading healthcare institution in France dedicated to advancing medical research and improving patient care through innovative clinical trials. As a prominent clinical trial sponsor, Chu de Reims focuses on a wide range of therapeutic areas, fostering collaboration between multidisciplinary teams of healthcare professionals and researchers. The hospital is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring that all trials are designed to deliver reliable data while prioritizing patient safety and well-being. Through its robust research infrastructure, Chu de Reims aims to contribute significantly to the advancement of medical knowledge and the development of new treatment options.

Locations

Reims, France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported