Hearing LossNCT01805167
Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients
A study testing Electrophysiological study of the interindividual variability of vocal performance in people with Hearing Loss, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Electrophysiological study of the interindividual variability of vocal performance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2013to 3 Feb 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject of French language
- Subject with a moderate bilateral sensorineural hearing loss, severe to profound
- Sensorineural hearing loss post-lingual (after onset of language acquisition)
- Subject paired with the implant Neurelec (Appendix 1) for more than 9 months
- Subject has received an appropriate setting under usual clinical follow-up
- Elderly 18 to 75 years
- Subject giving consent
Who cannot join
- Sensorineural hearing loss pre-lingual
- Deafness following a meningitis, or neurodegenerative diseases
- Illiteracy
- Pregnant women
- Subject blind
- Subject enjoying a measure of legal protection
- Subject incapable of giving consent
- Subject vulnerable
Trial locations and contacts
1 site in 1 country.
About this study
Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.
- Conditions
- Hearing Loss
- Being tested
- Electrophysiological study of the interindividual variability of vocal performance
- Keywords
- Subject with cochlear implant
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological study of the interindividual variability of vocal performanceOther
| Study group | Role | What they receive |
|---|---|---|
| subjects with a cochlear implant | Other | Not described Receives: Other: Electrophysiological study of the interindividual variability of vocal performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.
The vocal performance will be noted in percentage of voice recognition in the silence and in the noise.
And the electric interaction between the channels of stimulations will be estimated by the measure of the refractory period of the circuits of the hearing system with the PEAEP after stimulations of electrodes of intermediate situation in the cochlée (electrodes 11, 12 and 13)
Measured: At the inclusion - Day 0
Secondary outcomes (1)
Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance
Collection of the PEAEP after stimulation of 4 different electrodes distributed on the totality of door-electrode: generally, electrodes 4, 7, 10 and 13 will be stimulated. The amplitudes and the latencies of the waves II, III and V will be analyzed and compared with the vocal performances.
Measured: At the inclusion - Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study start4 Mar 2013
- Primary completion30 Sep 2013
- Study completion3 Feb 2014
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 Hearing LossStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Guevara, Dr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805167
- Sponsor's protocol ID
- 12-AOI-06
- Other IDs
- 2012-A01374-39
- Status last verified
- Jun 2026
- First submitted
- 22 Feb 2013
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guevara N, Hoen M, Truy E, Gallego S. A Cochlear Implant Performance Prognostic Test Based on Electrical Field Interactions Evaluated by eABR (Electrical Auditory Brainstem Responses). PLoS One. 2016 May 5;11(5):e0155008. doi: 10.1371/journal.pone.0155008. eCollection 2016.
PubMed 27149268
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients
- ClinicalTrials.gov ID
- NCT01805167
- Acronym / sponsor ID
- 12-AOI-06
- Conditions
- Hearing Loss
- Keywords
- Subject with cochlear implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Mar 2013 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 3 Feb 2014 (actual)
- First posted
- 6 Mar 2013 (estimated)
- 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.
Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with a cochlear implant | Other | Other: Electrophysiological study of the interindividual variability of vocal performance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject of French language
- Subject with a moderate bilateral sensorineural hearing loss, severe to profound
- Sensorineural hearing loss post-lingual (after onset of language acquisition)
- Subject paired with the implant Neurelec (Appendix 1) for more than 9 months
- Subject has received an appropriate setting under usual clinical follow-up
Key exclusion criteria (8 listed)
- Sensorineural hearing loss pre-lingual
- Deafness following a meningitis, or neurodegenerative diseases
- Illiteracy
- Pregnant women
- Subject blind
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 |
|---|---|---|
| Electrophysiological study of the interindividual variability of vocal performance | Other | subjects with a cochlear implant |
Primary outcome
Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.
Time frame: At the inclusion - Day 0
The vocal performance will be noted in percentage of voice recognition in the silence and in the noise. And the electric interaction between the channels of stimulations will be estimated by the measure of the refractory period of the circuits of the hearing system with the PEAEP after stimulations of electrodes of intermediate situation in the cochlée (electrodes 11, 12 and 13)
1 secondary outcome
Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance
Time frame: At the inclusion - Day 0
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 16 Jun 2026.
- Derived from this study: PubMed 27149268Guevara N, Hoen M, Truy E, Gallego S. A Cochlear Implant Performance Prognostic Test Based on Electrical Field Interactions Evaluated by eABR (Electrical Auditory Brainstem Responses). PLoS One. 2016 May 5;11(5):e0155008. doi: 10.1371/journal.pone.0155008. eCollection 2016.
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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.
Nicolas Guevara, Dr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiological study of the interindividual variability of vocal performance in people with Hearing Loss, run by Centre Hospitalier Universitaire de Nice 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 7 inclusion and 8 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 16 Jun 2026. 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?
Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation. (time frame: At the inclusion - Day 0). 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 NCT01805167, 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 16 Jun 2026.