Channel Interaction in Cochlear Implant and Speech Understanding in Noise

Cochlear Implants Clinical Trial

— 2IPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877211
• Other study ID #: 69HCL17_0434
• Status: Completed
• Phase: N/A
• Start date: February 24, 2019
• Est. completion date: February 18, 2021

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 18, 2021
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implants

Intervention

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.
• 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.
• 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.
• Tonal audiometry
Tonal audiometry will be performed with headphones
• Auditory canal examination
Otoscopic examination of external auditory canal and eardrum

Locations

Country	Name	City	State
France	ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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