DeafnessNEUROSYLLABICNCT02323256
Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
A study testing Auditory steady-state response ASSR, Speech-ABR and Acoustic Change Complex ACC in people with Deafness, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of… Read more about this study
- Who is it for?
- Ages 1 year to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Auditory steady-state response ASSR, Speech-ABR and Acoustic Change Complex ACC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to May 2018
- 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 1 year to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- native French speaker
- no medical treatment for behavior or neurological disorders
- normal or corrected vision
- right-handed
- normal ORL examination
- valid affiliation to social security
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- absence of participation to another study
- For the cochlear implanted patients:
- aged from 1 to 70
- bilateral severe to profound deafness
- cochlear implant
- congenital deafness, pre or post lingual
- For the normal-hearing subjects:
- Aged from 18 to 70
- Normal tonal audiometry
Who cannot join
- No signed consent
- Treatment for depression, epilepsy, Parkinson's or Alzheimer's disease
- Physical health deficiency
- Mental retardation
- Neurological or psychiatric disease incompatible with the testing procedure
- Schooling in a foreign language
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- Foreign language spoken at home with both parents
- Invalid social security
- For the normal hearing subjects, no known hearing deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools
This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.
- Conditions
- Deafness
- Being tested
- Auditory steady-state response ASSR, Speech-ABR, Acoustic Change Complex ACC, P1-N1-P2 complex and Mismatch Negativity MMN
- Keywords
- cochlear implant, deafness, audiometry, speech perception, severe to profound deafness restored with cochlear implantation
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory steady-state response ASSROther
comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities
Speech-ABROther
Also called comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables
Acoustic Change Complex ACCOther
comparison of ACC complex in response to changes within speech stimulation
P1-N1-P2 complex and Mismatch Negativity MMNOther
comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation
| Study group | Role | What they receive |
|---|---|---|
| newly cochlear implanted adult patients | Experimental | longitudinal group Receives: Other: Auditory steady-state response ASSR; Other: Speech-ABR; Other: Acoustic Change Complex ACC; Other: P1-N1-P2 complex and Mismatch Negativity MMN |
| newly cochlear implanted children | Experimental | longitudinal group Receives: Other: Auditory steady-state response ASSR; Other: Speech-ABR; Other: Acoustic Change Complex ACC; Other: P1-N1-P2 complex and Mismatch Negativity MMN |
| cochlear implanted adult patients (CI>1 year) | Active comparator | transversal group Receives: Other: Auditory steady-state response ASSR; Other: Speech-ABR; Other: Acoustic Change Complex ACC; Other: P1-N1-P2 complex and Mismatch Negativity MMN |
| normal hearing adult subjects | Active comparator | transversal group Receives: Other: Auditory steady-state response ASSR; Other: Speech-ABR; Other: Acoustic Change Complex ACC; Other: P1-N1-P2 complex and Mismatch Negativity MMN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of auditory steady state responses ASSR
Measured: one year at least after CI activation
Spectro-temporal analysis of speech-ABR
Measured: one year at least after CI activation
Acoustic Change Complex ACC
Amplitudes and latencies of ACC
Measured: one year at least after CI activation
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Measured: one year at least after CI activation
Evolution of amplitude of auditory steady state responses ASSR
Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of spectro-temporal analysis of speech-ABR
Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Acoustic Change Complex ACC
Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Evolution of amplitudes and latencies of P1N1P2 and MMN as a function of time during the first year of CI activation in newly implanted patients
Measured: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2018
- Study completionMay 2018
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 DeafnessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323256
- Sponsor's protocol ID
- 2014.857
- Other IDs
- 2014-A00345-42
- Acronym
- NEUROSYLLABIC
- Status last verified
- Aug 2025
- First submitted
- 15 Oct 2014
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Attina V, Mina F, Stahl P, Duroc Y, Veuillet E, Truy E, Thai-Van H. A New Method to Test the Efficiency of Cochlear Implant Artifacts Removal From Auditory Evoked Potentials. IEEE Trans Neural Syst Rehabil Eng. 2017 Dec;25(12):2453-2460. doi: 10.1109/TNSRE.2017.2723952. Epub 2017 Jul 6.
PubMed 28692981
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools
- ClinicalTrials.gov ID
- NCT02323256
- Acronym / sponsor ID
- NEUROSYLLABIC / 2014.857
- Conditions
- Deafness
- Keywords
- cochlear implant, deafness, audiometry, speech perception, severe to profound deafness restored with cochlear implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 23 Dec 2014 (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.
This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| newly cochlear implanted adult patients | Experimental | Other: Auditory steady-state response ASSR, Other: Speech-ABR, Other: Acoustic Change Complex ACC, Other: P1-N1-P2 complex and Mismatch Negativity MMNlongitudinal group |
| newly cochlear implanted children | Experimental | Other: Auditory steady-state response ASSR, Other: Speech-ABR, Other: Acoustic Change Complex ACC, Other: P1-N1-P2 complex and Mismatch Negativity MMNlongitudinal group |
| cochlear implanted adult patients (CI>1 year) | Active comparator | Other: Auditory steady-state response ASSR, Other: Speech-ABR, Other: Acoustic Change Complex ACC, Other: P1-N1-P2 complex and Mismatch Negativity MMNtransversal group |
| normal hearing adult subjects | Active comparator | Other: Auditory steady-state response ASSR, Other: Speech-ABR, Other: Acoustic Change Complex ACC, Other: P1-N1-P2 complex and Mismatch Negativity MMNtransversal group |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- native French speaker
- no medical treatment for behavior or neurological disorders
- normal or corrected vision
- right-handed
- normal ORL examination
Key exclusion criteria (9 listed)
- No signed consent
- Treatment for depression, epilepsy, Parkinson's or Alzheimer's disease
- Physical health deficiency
- Mental retardation
- Neurological or psychiatric disease incompatible with the testing procedure
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 |
|---|---|---|
| Auditory steady-state response ASSRcomparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities | Other | cochlear implanted adult patients (CI>1 year), newly cochlear implanted adult patients, newly cochlear implanted children, normal hearing adult subjects |
| Speech-ABRAlso: comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables | Other | cochlear implanted adult patients (CI>1 year), newly cochlear implanted adult patients, newly cochlear implanted children, normal hearing adult subjects |
| Acoustic Change Complex ACCcomparison of ACC complex in response to changes within speech stimulation | Other | cochlear implanted adult patients (CI>1 year), newly cochlear implanted adult patients, newly cochlear implanted children, normal hearing adult subjects |
| P1-N1-P2 complex and Mismatch Negativity MMNcomparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation | Other | cochlear implanted adult patients (CI>1 year), newly cochlear implanted adult patients, newly cochlear implanted children, normal hearing adult subjects |
Primary outcome
Amplitude of auditory steady state responses ASSR
Time frame: one year at least after CI activation
Spectro-temporal analysis of speech-ABR
Time frame: one year at least after CI activation
Acoustic Change Complex ACC
Time frame: one year at least after CI activation
Amplitudes and latencies of ACC
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Time frame: one year at least after CI activation
Evolution of amplitude of auditory steady state responses ASSR
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients
Evolution of spectro-temporal analysis of speech-ABR
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients
Acoustic Change Complex ACC
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of amplitudes and latencies of P1N1P2 and MMN as a function of time during the first year of CI activation in newly implanted patients
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 11 Aug 2025.
- Results publication: PubMed 28692981Attina V, Mina F, Stahl P, Duroc Y, Veuillet E, Truy E, Thai-Van H. A New Method to Test the Efficiency of Cochlear Implant Artifacts Removal From Auditory Evoked Potentials. IEEE Trans Neural Syst Rehabil Eng. 2017 Dec;25(12):2453-2460. doi: 10.1109/TNSRE.2017.2723952. Epub 2017 Jul 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory steady-state response ASSR, Speech-ABR and Acoustic Change Complex ACC in people with Deafness, 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 15 inclusion and 9 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 11 Aug 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?
Amplitude of auditory steady state responses ASSR (time frame: one year at least after CI activation). The study lists 8 primary outcomes in all. 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 NCT02323256, 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 11 Aug 2025.