Channel Interaction in Cochlear Implant and Speech Understanding in Noise

NCT ID: NCT03877211

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-24
• Study Completion Date: 2021-02-18

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.

Conditions

Cochlear Implants

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cochlear implant users

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

Group Type: EXPERIMENTAL

speech audiometry in noise

Intervention Type: 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

Intervention Type: 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)

Intervention Type: 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.

Normal-hearing subjects

Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry

Group Type: ACTIVE_COMPARATOR

speech audiometry in noise

Intervention Type: 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

Intervention Type: 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.

Tonal audiometry

Intervention Type: OTHER

Tonal audiometry will be performed with headphones

Auditory canal examination

Intervention Type: OTHER

Otoscopic examination of external auditory canal and eardrum

Interventions

speech audiometry in noise

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.

Intervention Type: OTHER

Psychophysical tuning curves in forward masking

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.

Intervention Type: OTHER

Electrically-evoked Auditory Brainstem Response (EABR)

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.

Intervention Type: OTHER

Tonal audiometry

Tonal audiometry will be performed with headphones

Intervention Type: OTHER

Auditory canal examination

Otoscopic examination of external auditory canal and eardrum

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric TRUY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot

Lyon, , France

Countries

France

References

Cucis PA, Berger-Vachon C, Thai-Van H, Hermann R, Gallego S, Truy E. Word Recognition and Frequency Selectivity in Cochlear Implant Simulation: Effect of Channel Interaction. J Clin Med. 2021 Feb 10;10(4):679. doi: 10.3390/jcm10040679.

Reference Type: RESULT

PMID: 33578696 (View on PubMed)

Other Identifiers

69HCL17_0434

Identifier Type: -

Identifier Source: org_study_id