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New treatment option for Structure Cochlea
Official title Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations
ClinicalTrials.gov ID: NCT06499584
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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)
You likely can't join if
- 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...
See the full eligibility 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...
- 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Reims, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reims, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.