Channel Interaction in Cochlear Implant and Speech Understanding in Noise

Not Applicable

Completed

• Conditions: Cochlear Implants
• Interventions: Other: speech audiometry in noise; Other: Psychophysical tuning curves in forward masking; Other: Electrically-evoked Auditory Brainstem Response (EABR); Other: Tonal audiometry; Other: Auditory canal examination

• Registration Number: NCT03877211
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-24
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Primary Completion: 2021-02-18
• Study Completion: 2021-02-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cochlear implant users	Electrically-evoked Auditory Brainstem Response (EABR)	Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement
Normal-hearing subjects	speech audiometry in noise	Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
Cochlear implant users	speech audiometry in noise	Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement
Normal-hearing subjects	Tonal audiometry	Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
Cochlear implant users	Psychophysical tuning curves in forward masking	Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement
Normal-hearing subjects	Psychophysical tuning curves in forward masking	Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
Normal-hearing subjects	Auditory canal examination	Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry

Primary Outcome Measures

Name	Time	Method
Percentage of syllable correctly recognized during speech audiometry test	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 Outcome Measures

Name	Time	Method
Sound masking threshold	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.
Electrically-evoked Auditory Brainstem Response (eABR)	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.

Trial Locations

Locations (1)

ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot; 🇫🇷 Lyon, France