Cochlear Hearing LossNCT03500718
Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
A study testing Cochlear implant in people with Cochlear Hearing Loss, run by Jawaharlal Institute of Postgraduate Medical Education & Research at 1 site in India.
Trial summary
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch on), after 3months and 6 months following… Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Hearing Loss
- What is being tested?
- Cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndia
- Study dates
- 26 Feb 2018to 31 Dec 2019
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children between 1 and 6 years of age undergoing cochlear implantation in JIPMER during the study period.
Who cannot join
- Incomplete electrode array insertion.
Trial locations and contacts
1 site in 1 country.
About this study
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch on), after 3months and 6 months following cochlear implantation.
Read the detailed description
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, 4 weeks(at switch on) and after 3months and 6 months following cochlear implantation. Neural Response Telemetry (NRT) is a quick and non-invasive way of recording ECAP of the peripheral auditory nerves in-situ. It gives clinicians valuable information for programming the T- (Threshold) and C-(Comfort) - levels of the recipient's speech processor map. Intraoperative NRT in conjunction with electrode impedance data can help indicate the integrity of the implanted electrodes and the electrode/auditory nerve interface, confirming that the implant is functioning correctly intraoperatively.
- Conditions
- Cochlear Hearing Loss
- Being tested
- Cochlear implant
- Keywords
- cochlear implant, threshold of electrically evoked compound action potential, neural response telemetry
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantDevice
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with bilateral sensorineural hearing loss | Experimental | One group will be studied: Patients undergoing cochlear implantation surgery between age 1 and 6 years who meet the above inclusion and exclusion criteria seen in JIPMER during the study period. Receives: Device: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in threshold of ECAP after cochlear implantation.
To evaluate changes in threshold of ECAP during cochlear implantation, at switch on( 4 weeks), after 3 months and 6 months following cochlear implantation.
Measured: during implantation, at switch on( 4 weeks), after 3months and 6months.
Secondary outcomes (2)
Correlate the amplitude of ECAP with T & C levels.
Correlating the amplitude of ECAP with threshold and comfortable levels and creating a MAP.
Measured: 2 years
Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.
By correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively.
Measured: 2 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start26 Feb 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cochlear Hearing LossStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jawaharlal Institute of Postgraduate Medical Education & Research
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Aparna Das, Jawaharlal Institute of Postgraduate Medical Education & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500718
- Sponsor's protocol ID
- JIP/IEC/2017/0339
- Status last verified
- Feb 2020
- First submitted
- 2 Apr 2018
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality regarding patient's participation in the study will be maintained throughout the study period as well as after completion of the study.
Publications
Kim JR, Abbas PJ, Brown CJ, Etler CP, O'Brien S, Kim LS. The relationship between electrically evoked compound action potential and speech perception: a study in cochlear implant users with short electrode array. Otol Neurotol. 2010 Sep;31(7):1041-8. doi: 10.1097/MAO.0b013e3181ec1d92.
PubMed 20634770van Eijl RH, Buitenhuis PJ, Stegeman I, Klis SF, Grolman W. Systematic review of compound action potentials as predictors for cochlear implant performance. Laryngoscope. 2017 Feb;127(2):476-487. doi: 10.1002/lary.26154. Epub 2016 Nov 2.
PubMed 27804133
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
- ClinicalTrials.gov ID
- NCT03500718
- Acronym / sponsor ID
- JIP/IEC/2017/0339
- Conditions
- Cochlear Hearing Loss
- Keywords
- cochlear implant, threshold of electrically evoked compound action potential, neural response telemetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Jawaharlal Institute of Postgraduate Medical Education & ResearchOther government
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Apr 2018 (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.
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch on), after 3months and 6 months following cochlear implantation.
Detailed description
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, 4 weeks(at switch on) and after 3months and 6 months following cochlear implantation. Neural Response Telemetry (NRT) is a quick and non-invasive way of recording ECAP of the peripheral auditory nerves in-situ. It gives clinicians valuable information for programming the T- (Threshold) and C-(Comfort) - levels of the recipient's speech processor map. Intraoperative NRT in conjunction with electrode impedance data can help indicate the integrity of the implanted electrodes and the electrode/auditory nerve interface, confirming that the implant is functioning correctly intraoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with bilateral sensorineural hearing loss | Experimental | Device: Cochlear implantOne group will be studied: Patients undergoing cochlear implantation surgery between age 1 and 6 years who meet the above inclusion and exclusion criteria seen in JIPMER during the study period. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children between 1 and 6 years of age undergoing cochlear implantation in JIPMER during the study period.
Key exclusion criteria (1 listed)
- Incomplete electrode array insertion.
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 implantAfter cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP). | Device | Pediatric patients with bilateral sensorineural hearing loss |
Primary outcome
Changes in threshold of ECAP after cochlear implantation.
Time frame: during implantation, at switch on( 4 weeks), after 3months and 6months.
To evaluate changes in threshold of ECAP during cochlear implantation, at switch on( 4 weeks), after 3 months and 6 months following cochlear implantation.
2 secondary outcomes
Correlate the amplitude of ECAP with T & C levels.
Time frame: 2 years
Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.
Time frame: 2 mins
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 24 Feb 2020.
- Background: PubMed 20634770Kim JR, Abbas PJ, Brown CJ, Etler CP, O'Brien S, Kim LS. The relationship between electrically evoked compound action potential and speech perception: a study in cochlear implant users with short electrode array. Otol Neurotol. 2010 Sep;31(7):1041-8. doi: 10.1097/MAO.0b013e3181ec1d92.
- Background: PubMed 27804133van Eijl RH, Buitenhuis PJ, Stegeman I, Klis SF, Grolman W. Systematic review of compound action potentials as predictors for cochlear implant performance. Laryngoscope. 2017 Feb;127(2):476-487. doi: 10.1002/lary.26154. Epub 2016 Nov 2.
- Individual participant dataSharing planned: No. Confidentiality regarding patient's participation in the study will be maintained throughout the study period as well as after completion of the study.
Related trials for Cochlear Hearing Loss
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
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Hearing Loss, Binaural, Cochlear Implantation
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Mi2000 TICI - Post-market Implantation Study
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A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
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Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
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 Cochlear implant in people with Cochlear Hearing Loss, run by Jawaharlal Institute of Postgraduate Medical Education & Research at 1 site in India.
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 1 inclusion and 1 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 24 Feb 2020. 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 India. 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?
Changes in threshold of ECAP after cochlear implantation. (time frame: during implantation, at switch on( 4 weeks), after 3months and 6months.). 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 NCT03500718, which also lists 2 linked publications.
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 24 Feb 2020.