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

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ClinicalTrials.gov Identifier: NCT03877211
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cochlear Implants 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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Channel Interaction on Cochlear Implant Performances in Noise : Influence of the Number of Maxima.
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : May 24, 2022
Estimated Study Completion Date : May 24, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of syllable correctly recognized during speech audiometry test [ Time Frame: 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 :
  1. Sound masking threshold [ Time Frame: 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.

  2. Electrically-evoked Auditory Brainstem Response (eABR) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877211


Contacts
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Contact: Eric TRUY, MD, PhD +33 (0)4.72.11.05.55 eric.truy@chu-lyon.fr
Contact: Hung THAI-VAN, MD, PhD hung.thai-van@chu-lyon.fr

Locations
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France
ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot Recruiting
Lyon, France, 69003
Contact: Eric TRUY, MD, PhD    +33 (0)4.72.11.05.55    eric.truy@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Eric TRUY, MD, PhD Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03877211    
Other Study ID Numbers: 69HCL17_0434
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
speech audiometry
psychophysical tuning curve
electrophysiology
auditory brainstem response