Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocal… (NCT06499584) | Clinical Trial Compass
RecruitingNot Applicable
Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations
France20 participantsStarted 2023-03-21
Plain-language summary
In humans, surface electrophysiological recordings of the cochlear nerve in response to a sound stimulus provide information about the cochlear's ability to encode sound. Depending on the stimulus, the fine structure and temporal envelope of the signal will vary, allowing us to determine its characteristics. By phenotyping patients before surgery using subjective and objective audiometric tests, it will be possible to isolate for each patient the moment when the fine structure disappears and when the temporal envelope is effective.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 parti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare the amplitude of coding of complex and ecological sounds
Timeframe: At 48 months
2
To compare the spectrum of coding of complex and ecological sounds