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NCT Number: NCT06499584

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

During functional cerebellopontine angle surgery, a spherical electrode is placed on the human cochlear nerve to monitor hearing. Once the electrode is in place, clicks and speech signals with and without noise are delivered to analyze the cochlear electrophysiological signal produced. Depending on the characteristics recorded, this signal can be used to determine how fine structure and temporal envelope are encoded by the cochlea. Prior to surgery, each patient is evaluated by an audiologist to determine quiet and noise thresholds, tone and speech, electrocochleography, distortion testing, tympanometry, ABR and psychoacoustic testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 particular anatomical feature not identified during the preoperative examination, making its exposure for recordings impossible (protrusion of the posterior face of the rock).

Treatment and study plan

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

Procedure

During surgery using a retro-sigmoid approach in the cerebellopontine angle (microvascular decompression), near-field recording of human auditory nerve activity using a contact electrode is performed on patients with normal or impaired hearing threshold.

Each patient is explored preoperatively by hearing tests. During the surgery, stimuli are delivered.

Primary outcomes

  1. To compare the amplitude of coding of complex and ecological sounds

    Time frame: At 48 months

    The goal is to compare the amplitude of coding of complex and ecological sounds (logatomes in the form of vowels or syllables: association of a consonant and a vowel) in the human auditory nerve between patients defined as normo and poorly hearing according to preoperative audiometric tests.

  2. To compare the spectrum of coding of complex and ecological sounds

    Time frame: At 48 months

    The goal is to compare the spectrum of coding of complex and ecological sounds (logatomes in the form of vowels or syllables: association of a consonant and a vowel) in the human auditory nerve between patients defined as normo and poorly hearing according to preoperative audiometric tests.

Secondary outcomes

  1. The spectrum of the temporal envelope of the signal

    Time frame: At 48 months

    To study the spectrum of the temporal envelope of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups.

  2. The amplitude of the temporal envelope of the

    Time frame: at 48 months

    To study the amplitude of the temporal envelope of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups.

  3. The spectrum of the fine structure of the signal

    Time frame: at 48 months

    To study the spectrum of the fine structure of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups.

  4. The amplitude of the fine structure of the signal

    Time frame: at 48 months

    To study the amplitude of the fine structure of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc LABROUSSE

CONTACT

[email protected]

03 26 78 71 25 ext. 0033

Xavier DUBERNARD

CONTACT

[email protected]

03 26 78 71 25 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

The Functional Role of Cochlear Synaptopathy for Speech Coding in the Brain

Acronym: CosySpeech

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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