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Channel Interaction in Cochlear Implant and Speech Understanding in Noise

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03877211
Acronym
2IPIC
Enrollment
28
Registered
2019-03-15
Start date
2019-02-24
Completion date
2021-02-18
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Implants

Keywords

speech audiometry, psychophysical tuning curve, electrophysiology, auditory brainstem response

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.

Interventions

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.

OTHERPsychophysical 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.

OTHERElectrically-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.

OTHERTonal audiometry

Tonal audiometry will be performed with headphones

OTHERAuditory canal examination

Otoscopic examination of external auditory canal and eardrum

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of syllable correctly recognized during speech audiometry testAt inclusionSubjects 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

MeasureTime frameDescription
Sound masking thresholdAt inclusionMeasurement 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 inclusionChannel 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026