Cochlear ImplantNCT02966379
Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
A study testing cochlear implantation in people with Cochlear Implant, run by Oticon Medical at 8 sites in France.
Trial summary
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant
- What is being tested?
- cochlear implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 8 sitesFrance
- Study dates
- 30 Mar 2016to 2 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreement to participate
- Above 18 years old
- Candidate for cochlear implantation
- Residual hearing in low frequencies (auditory thresholds better than or equal to 70 dB up to 500 Hz
- Native or fluent French speaker
Who cannot join
- No affiliation to social security
- No agreement
- Vulnerable patient
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Bordeaux Pellegrin
Bordeaux
CHRU Lille Hôpital Roger Salengro
Lille
CHU Lyon Hôpital Edouard Herriot
Lyon
APHM - Hôpital Nord Marseille
Marseille
CHRU de Nancy hôpital Central
Nancy
IUFC - CHU Nice
Nice
APHP Pitie salpetriere
Paris
CHU Rennes Pontchaillou
Rennes
About this study
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead.
The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.
Read the detailed description
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. Literature showed the EAS stimulation can lead to better speech understanding, especially in noisy situation, and can provide important information about intonating or melodic contours, thus increasing sound quality and music perception.
Objectives The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead.
The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.
Methods Unaided tonal audiograms are measured for cochlear implant candidates with low frequency residual hearing before and after cochlear implantation with the EVO electrode lead.
Aided tonal audiograms and speech intelligibility in quiet and in noise are measured after implantation with the three modes of stimulation (acoustic stimulation AS, electric stimulation ES, and electro-acoustic stimulation EAS).
- Conditions
- Cochlear Implant
- Being tested
- cochlear implantation
- Keywords
- Electroacoustic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantationDevice
Surgery is standardized in order to have the same procedure for all patients and to preserve a maximum of residual hearing:
- Corticosteroïds (1mg/kg solumedrol) at anesthetic induction ,
- mastoidectomy + posterieur tympanostomy ,
- insertion through round window,
- stop at the first resistance point
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implantation | Experimental | Cochlear implantation with EVO electrode lead. This electrode lead has been specially designed for atraumatic surgery, in order to preserve the residual hearing of the patients included in the study. All patients are implanted with the same electrode lead. Receives: Device: cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz between pre and post implantation
Change from pre-implantation pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz at 1 month post implantation with the EVO electrode lead and at 1, 3, 6 and 12 months post-activation
Measured: 2 weeks pre-implantation, 1 month post-implantation, 1, 3, 6 and 12 months post-activation
Secondary outcomes (5)
Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" presented in quiet with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS).
Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" when presented in quiet with the three modes of stimulation (AS, ES and EAS). Speech understanding is evaluated at 3, 6 and 12 months post activation
Measured: 3, 6 and 12 months post activation
Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" presented in cocktail party noise with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS).
Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" when presented in cocktail party noise at 0 and +10 dB Speech to Noise Ratio (SNR) with the three modes of stimulation (AS, ES and EAS). Speech understanding is evaluated at 3, 6 and 12 months post activation
Measured: 3, 6 and 12 months post activation
Quality of life questionnaire. Evaluation of satisfaction on a scale from 0 (unsatisfactory) to 10 (satisfactory) of everyday life listening situations.
Measured: 2 weeks pre op, 3, 6 and 12 months post-activation
Intonation perception task measuring the JND (just noticeable difference) in frequency necessary to discriminate two sounds
Measured: 6 and 12 months post activation
Surgery questionnaire evaluating the surgical technique, the presence of problems during surgery, the quality of insertion and surgeon satisfaction with multiple choice questions, close questions and scales from 0 to 10.
Surgery questionnaire evaluating the surgical technique (multiple choice questions), the presence of problems during surgery (multiple choice questions), the difficulty of insertion of the implant (scales from 0 - impossible to 5 - very easy; or 0 -very easy to 5 - impossible on inverted questions), the tools used for the insertion (multiple choice questions), the duration of insertion (secondes or minutes),the number of electrode inserted, the number of attempts to insert, and surgeon satisfaction (multiple choice questions between "easy", "medium" and "difficult")
Measured: single evaluation at implantation only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start30 Mar 2016
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Gnansia, Dr, Study director, Oticon MedicalYann NGUYEN, Dr, Principal investigator, APHP Pitie salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966379
- Sponsor's protocol ID
- PIC_06
- Status last verified
- Oct 2021
- First submitted
- 9 Nov 2016
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
- ClinicalTrials.gov ID
- NCT02966379
- Acronym / sponsor ID
- PIC_06
- Conditions
- Cochlear Implant
- Keywords
- Electroacoustic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 17 Nov 2016 (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.
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead.
The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.
Detailed description
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. Literature showed the EAS stimulation can lead to better speech understanding, especially in noisy situation, and can provide important information about intonating or melodic contours, thus increasing sound quality and music perception.
Objectives The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead.
The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.
Methods Unaided tonal audiograms are measured for cochlear implant candidates with low frequency residual hearing before and after cochlear implantation with the EVO electrode lead.
Aided tonal audiograms and speech intelligibility in quiet and in noise are measured after implantation with the three modes of stimulation (acoustic stimulation AS, electric stimulation ES, and electro-acoustic stimulation EAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implantation | Experimental | Device: cochlear implantationCochlear implantation with EVO electrode lead. This electrode lead has been specially designed for atraumatic surgery, in order to preserve the residual hearing of the patients included in the study. All patients are implanted with the same electrode lead. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Agreement to participate
- Above 18 years old
- Candidate for cochlear implantation
- Residual hearing in low frequencies (auditory thresholds better than or equal to 70 dB up to 500 Hz
- Native or fluent French speaker
Key exclusion criteria (3 listed)
- No affiliation to social security
- No agreement
- Vulnerable patient
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 |
|---|---|---|
| cochlear implantationSurgery is standardized in order to have the same procedure for all patients and to preserve a maximum of residual hearing: * Corticosteroïds (1mg/kg solumedrol) at anesthetic induction , * mastoidectomy + posterieur tympanostomy , * insertion through round window, * stop at the first resistance point | Device | Cochlear implantation |
Primary outcome
Change in pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz between pre and post implantation
Time frame: 2 weeks pre-implantation, 1 month post-implantation, 1, 3, 6 and 12 months post-activation
Change from pre-implantation pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz at 1 month post implantation with the EVO electrode lead and at 1, 3, 6 and 12 months post-activation
5 secondary outcomes
Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" presented in quiet with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS).
Time frame: 3, 6 and 12 months post activation
Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" presented in cocktail party noise with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS).
Time frame: 3, 6 and 12 months post activation
Quality of life questionnaire. Evaluation of satisfaction on a scale from 0 (unsatisfactory) to 10 (satisfactory) of everyday life listening situations.
Time frame: 2 weeks pre op, 3, 6 and 12 months post-activation
Intonation perception task measuring the JND (just noticeable difference) in frequency necessary to discriminate two sounds
Time frame: 6 and 12 months post activation
Surgery questionnaire evaluating the surgical technique, the presence of problems during surgery, the quality of insertion and surgeon satisfaction with multiple choice questions, close questions and scales from 0 to 10.
Time frame: single evaluation at implantation only
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 14 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implant
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
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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.
Dan Gnansia, Dr study director
Oticon Medical
Yann NGUYEN, Dr principal investigator
APHP Pitie salpetriere
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cochlear implantation in people with Cochlear Implant, run by Oticon Medical at 8 sites 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 5 inclusion and 3 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Change in pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz between pre and post implantation (time frame: 2 weeks pre-implantation, 1 month post-implantation, 1, 3, 6 and 12 months post-activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021.