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New treatment option for Hearing Loss
Official title Coding of Speech Signals in the Human Auditory Nerve
ClinicalTrials.gov ID: NCT06490237
What this study is testing
- What it's testing
- The fine evaluation of the function of auditory neurons in silence and in noise in humans is difficult, if not impossible, to date with the conventional methods available. That is why in certain situations, the hearing aids of patient with hearing loss fail, especially in the presence of noise.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Will be included as hearing impaired patients:
- male or female
- over 18 years of age
- who are to undergo surgery on the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma...
- with a mild to severe sensorineural hearing loss defined by an average hearing loss (average of thresholds obtained at 500, 1000, 2000 and 4000 Hz)...
You likely can't join if
- Patients for whom the auditory nerve is not accessible during surgery,
- because of a complete tumor invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma)
- because of an anatomical feature not identified during the preoperative examination, making its exposure for recordings impossible (protrusion of the...
See the full eligibility criteria
- Will be included as hearing impaired patients:
- male or female
- over 18 years of age
- who are to undergo surgery on the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor)
- with a mild to severe sensorineural hearing loss defined by an average hearing loss (average of thresholds obtained at 500, 1000, 2000 and 4000 Hz) greater than 20 dB and less than 90 dB in pure tone bone conduction...
- affiliated to a social security system.
- have read the information note describing the study and have agreed in writing to participate by signing the informed consent form. Will be included as normal hearing patients:
- male or female
- over 18 years of age
- who are to undergo surgery in the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor)
- free of neuro-sensory deafness, defined by average hearing thresholds less than or equal to 20 dB in tonal bone conduction audiometry on the side of the operated ear
- affiliated with a social security system.
- having read the information note describing the study and having agreed in writing to participate by signing the informed consent form.
- Patients for whom the auditory nerve is not accessible during surgery,
- because of a complete tumor invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma)
- because of an 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 and older. 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.