Cochlear Implants2IPICNCT03877211
Channel Interaction in Cochlear Implant and Speech Understanding in Noise
A study testing speech audiometry in noise, Psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) in people with Cochlear Implants, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implants
- What is being tested?
- speech audiometry in noise, Psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2019to 18 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot
Lyon, 69003
About this study
Official title: 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.
- Conditions
- Cochlear Implants
- Being tested
- speech audiometry in noise, Psychophysical tuning curves in forward masking, Electrically-evoked Auditory Brainstem Response (EABR), Tonal audiometry, Auditory canal examination
- Keywords
- speech audiometry, psychophysical tuning curve, electrophysiology, auditory brainstem response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech audiometry in noiseOther
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 maskingOther
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)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.
Tonal audiometryOther
Tonal audiometry will be performed with headphones
Auditory canal examinationOther
Otoscopic examination of external auditory canal and eardrum
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant users | Experimental | 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 Receives: Other: speech audiometry in noise; Other: Psychophysical tuning curves in forward masking; Other: Electrically-evoked Auditory Brainstem Response (EABR) |
| Normal-hearing subjects | Active comparator | Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry Receives: Other: speech audiometry in noise; Other: Psychophysical tuning curves in forward masking; Other: Tonal audiometry; Other: Auditory canal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start24 Feb 2019
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric TRUY, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877211
- Sponsor's protocol ID
- 69HCL17_0434
- Acronym
- 2IPIC
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33578696
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Channel Interaction on Cochlear Implant Performances in Noise : Influence of the Number of Maxima.
- ClinicalTrials.gov ID
- NCT03877211
- Acronym / sponsor ID
- 2IPIC / 69HCL17_0434
- Conditions
- Cochlear Implants
- Keywords
- speech audiometry, psychophysical tuning curve, electrophysiology, auditory brainstem response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Feb 2019 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant users | Experimental | Other: speech audiometry in noise, Other: Psychophysical tuning curves in forward masking, Other: Electrically-evoked Auditory Brainstem Response (EABR)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 |
| Normal-hearing subjects | Active comparator | Other: speech audiometry in noise, Other: Psychophysical tuning curves in forward masking, Other: Tonal audiometry, Other: Auditory canal examinationNormal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Fluent in French
- Able to understand written instructions
- Under French public medical insurance
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speech audiometry in noiseSubjects 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 | Cochlear implant users, Normal-hearing subjects |
| Psychophysical tuning curves in forward maskingSounds 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 | Cochlear implant users, Normal-hearing subjects |
| 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. | Other | Cochlear implant users |
| Tonal audiometryTonal audiometry will be performed with headphones | Other | Normal-hearing subjects |
| Auditory canal examinationOtoscopic examination of external auditory canal and eardrum | Other | Normal-hearing subjects |
Primary outcome
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.
2 secondary outcomes
Sound masking threshold
Time frame: At inclusion
Electrically-evoked Auditory Brainstem Response (eABR)
Time frame: Up to 12 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 33578696Cucis 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.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implants
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric TRUY, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speech audiometry in noise, Psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) in people with Cochlear Implants, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of syllable correctly recognized during speech audiometry test (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03877211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.