Cochlear Prosthesis ImplantationeCochGICNCT04561388
Electrocochleography Along Cochlear Implant Auditory Rehabilitation
A study testing Electrocochleography, Pure Tone Audiometry and Speech audiometry in people with Cochlear Prosthesis Implantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Electrocochleography (eCochG) is an electrophysiological measurement to evaluate the activity of cochlear hair cells in response to acoustic stimulation. This measure thus reflects the functional state of the cochlea and more specifically the neuronal survival. Read more about this study
- Who is it for?
- Ages 8 to 75 years
- Conditions the study is for
- Cochlear Prosthesis Implantation
- What is being tested?
- Electrocochleography, Pure Tone Audiometry and Speech audiometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2022to 2 Dec 2022
- 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 8 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects, male or female, aged 8 to 75 ;
- Candidates for cochlear implantation with measurable residual hearing?
- French must be the mother tongue and is (or has been) the language of schooling;
- No ototoxic or neurotropic drug treatment (epilepsy, behavioral disorders, other neurological impairment);
- No known cognitive disorders, neurodegenerative disorders (Alzheimer's, Parkinson's, ...), psychiatric pathologies (depression, schizophrenia, eating disorders, ...) or neurodevelopmental disorders (attention deficit disorder with or without hyperactivity, autism spectrum disorder, specific learning disorder);
- Absence of uncorrected visual problems;
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- Normal ENT examination;
- Valid membership in a social security system;
- Non-participation in another study;
- Absence of exposure to loud noise in the 72 hours preceding the experiments;
- Written consent to free and informed participation signed by the subject and his/her legal guardians in the case of minors.
Who cannot join
- Absence of signature of the informed consent by the adult subject and/or the parents of the minor subject ;
- Subjects speaking a foreign language at home and/or whose schooling was conducted in a foreign language (except for subjects attending bilingual schools and one of whose parents' usual language is French);
- Subjects undergoing ototoxic or neurotropic drug treatment (epilepsy, behavioural disorders, other neurological impairment);
- Subjects suffering from cognitive deficits, neurodegenerative disorders (Alzheimer's, Parkinson's, ...), psychiatric pathologies (depression, schizophrenia, eating disorders, ...) or neurodevelopmental disorders (attention deficit disorder with or without hyperactivity, autism spectrum disorder, specific learning disorder);
- General state of health incompatible with the protocols;
- Disability(ies) associated with deafness (deaf-blindness, ...) ;
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- Exposure to intense noise in the 72 hours preceding the experiment.
- Non-affiliation to a social security system.
- Pregnant or breastfeeding woman
- Subjects deprived of liberties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Electrocochleography for the Longitudinal Evaluation of Residual Hearing in Hearing Rehabilitation With Cochlear Implant
Electrocochleography (eCochG) is an electrophysiological measurement to evaluate the activity of cochlear hair cells in response to acoustic stimulation. This measure thus reflects the functional state of the cochlea and more specifically the neuronal survival.
Whereas in the normal-hearing subject, eCochG collection requires the introduction of a collection electrode in the middle ear, closest to the cochlea, in the cochlear implant subject, eCochG can be collected through the electrodes of the cochlear implant.
Read more
Measured during surgery, eCochGs may help optimize the placement of the electrode array within the cochlea and help in the decision to refer the patient to a conventional cochlear implant or, when residual cochlear activity is detected, to an electro-acoustic implant system.
The main objective of this study is to evaluate the usefulness of intra-operative eCochG collections for the optimization of electrode array placement within the cochlea and then for monitoring the residual hearing and its relationship to hearing performance during the first months of rehabilitation.
- Conditions
- Cochlear Prosthesis Implantation
- Being tested
- Electrocochleography, Pure Tone Audiometry, Speech audiometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocochleographyProcedure or surgery
Electrocochleographic responses will be evoked using different pure tone sounds delivered through an insert placed in the external auditory duct. The responses will be recorded with the electrodes of the cochlear implant connected to a dedicated interface.
Electrocochleographic responses will be collected continuously during the electrode-array insertion at the implantation surgery using 500Hz pure tone and after suturing with 250, 500, 750 and 1000Hz pure tones. Then, electrocochleographic responses to pure tones from 125 to 8000HZ (according to the subject residual hearing) will be recorded 2 weeks, 1 month, 2 months and 4 months after implantation.
Pure Tone AudiometryOther
The perception thresholds to 125, 250, 500, 750, 1000, 2000, 4000 and 8000 Hz pure tones will be measured within the month preceding the implantation using the same insert t.
Pure tone audiometry with the same frequencies will be done 2 weeks, 1, 2 and 4 months after the implantation.
Speech audiometryOther
The speech perception will be assessed in silence and in noise in free field 1 and 4 months after implantation. The speech perception in silence will be assessed using monosyllabic words 60 dB SPL. Speech in noise will be assessed using an adaptative test with fixed noise level (60 dB SPL).
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant candidates with measurable residual hearing | Other | Electrocochleography responses to acoustic will be recorded during the cochlear implantation and the 6 first months of use of the cochlear implant.
A pure tone audiometry will be done prior and after the implantation. Speech audiometry will be done twice after the cochlear implantation. Receives: Procedure: Electrocochleography; Other: Pure Tone Audiometry; Other: Speech audiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Electrocochleographic responses
The amplitudes of electrocochleographic responses (in µV) to the selected acoustic pure tones will be collected.
Measured: During surgery to 4 month after implantation
Secondary outcomes (2)
Pure tone thresholds
The perception thresholds (in dB HL) of the selected acoustic pure tones will be collected.
No safety issue
Measured: before implantation, 2 weeks, 1 month, 2 month and 4 month after implantation
Speech audiometry measurements
For the speech audiometry in silence, the percentage of correct recognition of monosyllabic words' list will be collected. For the speech audiometry in noise, the signal noise ratio(s) (in dB) permitting the subject to reach 50% and/or 70% of speech recognition (SRT50 and SRT70) will be estimated.
No safety issue
Measured: 1 month , 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start2 Dec 2022
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Why it stopped: patient recruitment problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Prosthesis ImplantationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung THAI VAN, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561388
- Sponsor's protocol ID
- 69HCL18_0926
- Acronym
- eCochGIC
- Status last verified
- Dec 2022
- First submitted
- 16 Sep 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Electrocochleography for the Longitudinal Evaluation of Residual Hearing in Hearing Rehabilitation With Cochlear Implant
- ClinicalTrials.gov ID
- NCT04561388
- Acronym / sponsor ID
- eCochGIC / 69HCL18_0926
- Conditions
- Cochlear Prosthesis Implantation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: patient recruitment problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 23 Sep 2020 (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.
Electrocochleography (eCochG) is an electrophysiological measurement to evaluate the activity of cochlear hair cells in response to acoustic stimulation. This measure thus reflects the functional state of the cochlea and more specifically the neuronal survival.
Whereas in the normal-hearing subject, eCochG collection requires the introduction of a collection electrode in the middle ear, closest to the cochlea, in the cochlear implant subject, eCochG can be collected through the electrodes of the cochlear implant.
Measured during surgery, eCochGs may help optimize the placement of the electrode array within the cochlea and help in the decision to refer the patient to a conventional cochlear implant or, when residual cochlear activity is detected, to an electro-acoustic implant system.
The main objective of this study is to evaluate the usefulness of intra-operative eCochG collections for the optimization of electrode array placement within the cochlea and then for monitoring the residual hearing and its relationship to hearing performance during the first months of rehabilitation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant candidates with measurable residual hearing | Other | Procedure: Electrocochleography, Other: Pure Tone Audiometry, Other: Speech audiometryElectrocochleography responses to acoustic will be recorded during the cochlear implantation and the 6 first months of use of the cochlear implant. A pure tone audiometry will be done prior and after the implantation. Speech audiometry will be done twice after the cochlear implantation. |
Who may qualify
- Ages
- 8 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects, male or female, aged 8 to 75 ;
- Candidates for cochlear implantation with measurable residual hearing?
- French must be the mother tongue and is (or has been) the language of schooling;
- No ototoxic or neurotropic drug treatment (epilepsy, behavioral disorders, other neurological impairment);
- No known cognitive disorders, neurodegenerative disorders (Alzheimer's, Parkinson's, ...), psychiatric pathologies (depression, schizophrenia, eating disorders, ...) or neurodevelopmental disorders (attention deficit disorder with or without hyperactivity, autism spectrum disorder, specific learning disorder);
Key exclusion criteria (10 listed)
- Absence of signature of the informed consent by the adult subject and/or the parents of the minor subject ;
- Subjects speaking a foreign language at home and/or whose schooling was conducted in a foreign language (except for subjects attending bilingual schools and one of whose parents' usual language is French);
- Subjects undergoing ototoxic or neurotropic drug treatment (epilepsy, behavioural disorders, other neurological impairment);
- Subjects suffering from cognitive deficits, neurodegenerative disorders (Alzheimer's, Parkinson's, ...), psychiatric pathologies (depression, schizophrenia, eating disorders, ...) or neurodevelopmental disorders (attention deficit disorder with or without hyperactivity, autism spectrum disorder, specific learning disorder);
- General state of health incompatible with the protocols;
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 |
|---|---|---|
| ElectrocochleographyElectrocochleographic responses will be evoked using different pure tone sounds delivered through an insert placed in the external auditory duct. The responses will be recorded with the electrodes of the cochlear implant connected to a dedicated interface. Electrocochleographic responses will be collected continuously during the electrode-array insertion at the implantation surgery using 500Hz pure tone and after suturing with 250, 500, 750 and 1000Hz pure tones. Then, electrocochleographic responses to pure tones from 125 to 8000HZ (according to the subject residual hearing) will be recorded 2 weeks, 1 month, 2 months and 4 months after implantation. | Procedure or surgery | Cochlear implant candidates with measurable residual hearing |
| Pure Tone AudiometryThe perception thresholds to 125, 250, 500, 750, 1000, 2000, 4000 and 8000 Hz pure tones will be measured within the month preceding the implantation using the same insert t. Pure tone audiometry with the same frequencies will be done 2 weeks, 1, 2 and 4 months after the implantation. | Other | Cochlear implant candidates with measurable residual hearing |
| Speech audiometryThe speech perception will be assessed in silence and in noise in free field 1 and 4 months after implantation. The speech perception in silence will be assessed using monosyllabic words 60 dB SPL. Speech in noise will be assessed using an adaptative test with fixed noise level (60 dB SPL). | Other | Cochlear implant candidates with measurable residual hearing |
Primary outcome
Change in Electrocochleographic responses
Time frame: During surgery to 4 month after implantation
The amplitudes of electrocochleographic responses (in µV) to the selected acoustic pure tones will be collected.
2 secondary outcomes
Pure tone thresholds
Time frame: before implantation, 2 weeks, 1 month, 2 month and 4 month after implantation
Speech audiometry measurements
Time frame: 1 month , 4 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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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.
Hung THAI VAN, MD 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 Electrocochleography, Pure Tone Audiometry and Speech audiometry in people with Cochlear Prosthesis Implantation, 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 11 inclusion and 10 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: withdrawn, as of the sponsor's last update on 6 Dec 2022. 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 was withdrawn before enrolling participants, so there are no results.
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 Electrocochleographic responses (time frame: During surgery to 4 month after implantation). 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 6 Dec 2022.