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Completed

NCT Number: NCT03877211

Channel Interaction in Cochlear Implant and Speech Understanding in Noise

The goal of this study is to take into account channel interaction in the cochlear implant (CI) fitting process. Designing a fast and accurate method of measurement would help to customize the fitting procedures to patients' specificities in order to maximize speech understanding in every day conditions especially in noise.

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Key information

Conditions

Cochlear Implants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Fluent in French
  • Able to understand written instructions
  • Under French public medical insurance
  • Normal-hearing subjects only:
  • Adult between 18 and 50 years old
  • Without a remarkable otological medical history, for example: chronic otitis, trans-tympanic tubes and / or all ear surgeries;
  • Clear auditory canal and normal eardrum;
  • Average audiometric loss under 20 decibels Hearing Level (dB HL)
  • Cochlear implant users only:
  • Adult between 18 and 60 yo
  • Normal middle ear
  • Used the cochlear implant for more than a year
  • Wearing a device from the company Neurelec/Oticon Medical

Exclusion criteria

  • Behavioral and/or neurological disorders
  • Proven psychological disorder
  • Use of psychotropic medication
  • People who experience migraine attacks on a regular basis
  • Use of ototoxic medication
  • Exposed to loud noises within the last 72 hours
  • Included in another clinical trial that uses medication

Treatment and study plan

speech audiometry in noise

Other

Subjects will be asked to repeat lists of words played by speakers in a noisy environment generated by the same speakers. A percentage of correct recognition is calculated for each list.

Psychophysical tuning curves in forward masking

Other

Sounds of variable center frequency are used as maskers, and a tone with a fixed frequency at a fixed level is the target. What is tested here is the level of masker that just masks the target.

Electrically-evoked Auditory Brainstem Response (EABR)

Other

Channel interaction assessment using eABRs (auditory nerve responses). The method consists of two measurements: 1) eABR measurements with stimulation by a single electrode of the cochlear implant at 70% of the dynamic range (four different electrodes are tested); 2) Measurement of a single eABR with stimulation from all four electrodes at 70% of the dynamic range. A comparison of the eABRs obtained by these two measurements, indicates the electrical and neural interactions between the electrodes.

Tonal audiometry

Other

Tonal audiometry will be performed with headphones

Auditory canal examination

Other

Otoscopic examination of external auditory canal and eardrum

Primary outcomes

  1. Percentage of syllable correctly recognized during speech audiometry test

    Time frame: At inclusion

    Subjects will be asked to repeat lists of words played by speakers in a noisy environment generated by the same speakers. A percentage of correct recognition is calculated for each list.

Secondary outcomes

  1. Sound masking threshold

    Time frame: At inclusion

    Measurement of channel interaction by establishing psychophysical tuning curves in forward masking. Sounds of variable center frequency are used as a masker, and a tone with a fixed frequency at a fixed level is the target. What is tested here is the level of masker that just masks the target.

  2. Electrically-evoked Auditory Brainstem Response (eABR)

    Time frame: Up to 12 months after inclusion

    Channel interaction assessment using eABRs (auditory nerve responses). The method consists of two measurements: 1) eABR measurements with stimulation by a single electrode of the cochlear implant at 70% of the dynamic range (four different electrodes are tested); 2) Measurement of a single eABR with stimulation from all four electrodes at 70% of the dynamic range. A comparison of the eABRs obtained by these two measurements, indicates the electrical and neural interactions between the electrodes.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Impact of Channel Interaction on Cochlear Implant Performances in Noise : Influence of the Number of Maxima.

Acronym: 2IPIC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2019
Registry last updated
Sep 4, 2025

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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