Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers
Key facts
- Who runs it
- University Hospital, Clermont-Ferrand
- Where
- Clermont-Ferrand, FranceSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 220 people, planned
- Started
- 29 Apr 2019
- Expected to end
- Apr 2028
- Type of study
- Interventional
- Treatments tested
- Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways
- Record updated
- 17 June 2026
Who can take part
- Age
- 18 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Between 18 and 55 years old
- be affiliated to a social security system
- understand (oral and written) of the French language
- be a qualified hearing with normal tympanogram and audiogram
Who cannot take part
- healthy volunteer who has received compensation equal to or greader than 4500€ in clinical study
- have ear infections and/or ENT medical history
- have cardiovascular, metabolic, neurological and psychiatric desease
- have a complaint of hearing
- have a exposure to noise (professional and/or activities)
- refusal to participate in the study
- being a protected person
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Where in France
- CHU Clermont-FerrandClermont-Ferrand, FranceContact: Lise LaclautreTaking people
About the trial
What the trial wants to find out
Acoustic overexposure can induced temporary or hearing loss. Usually hearing loss is associated with cochlear cell damages. Recently, a new pathological entity was described and called "hidden hearing loss". In animal model, the histopathology revealed a selective reduction in the number of auditory fibers, resulting in a decrease in the amplitude of wave I of the auditory brainstem response. Electrocochleography (Ecog) is a method for recording the electrical potentials of the cochlea (e.g. wave I). In clinical routine, Ecog is performed invasively with sedation or local anesthesia. Actually, a non invasive approach could be perform but it seems necessary to optimize this method and to define reference values in healthy volunteers.
The group in the trial
- Cohort 1Treatment being tested
Treatment: Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT04198909, who can take part
- Record updated
- 17 June 2026