Channel Interaction in Cochlear Implant and Speech Understanding in Noise (2IPIC)

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

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.

Study Overview

• Status: Completed
• Conditions: Cochlear Implants
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.; 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.; 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.
Active Comparator: 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	Other: 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.; 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.; Other: Tonal audiometry; Tonal audiometry will be performed with headphones; Other: Auditory canal examination; Otoscopic examination of external auditory canal and eardrum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of syllable correctly recognized during speech audiometry test	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.	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sound masking threshold	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.	At inclusion
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.	Up to 12 months after inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Eric TRUY, MD, PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2019
• Primary Completion (Actual): February 18, 2021
• Study Completion (Actual): February 18, 2021

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: electrophysiology; speech audiometry; psychophysical tuning curve; auditory brainstem response
• Other Study ID Numbers: 69HCL17_0434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No