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

Key facts

Who runs it
CHU de Reims
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
20 people, planned
Started
21 Mar 2023
Expected to end
Dec 2027
Type of study
Interventional, 2 groups
Treatments tested
  • near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
Record updated
12 July 2024

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

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 80 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • normal hearing patientsTreatment being tested

    free of sensorineural hearing loss, defined by mean hearing thresholds of less than or equal to 20 dB HL in air conduction pure tone audiometry, bilaterally on the side of the operated ear and on the non-operated side at 0.5, 1, 2 and 4 kHz.

    Treatment: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode

  • hearing impaired patientsTreatment being tested

    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.

    Treatment: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Functional Role of Cochlear Synaptopathy for Speech Coding in the Brain
Fit questions
Built from NCT06499584, who can take part
Record updated
12 July 2024
Under construction, not live – Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations (NCT06499584) – Frontlight Research