An interventional study of Cochlear implant in Cochlear Hearing Loss, sponsored by Jawaharlal Institute of Postgraduate Medical Education & Research. Completed at 1 site in India. Open to participants aged 1 Year to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Jawaharlal Institute of Postgraduate Medical Education & Research · Not applicable, Interventional, and Treatment
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.
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.
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.
This study's enrollment of 44 is above the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →Jawaharlal Institute of Postgraduate Medical Education & Research is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Cochlear implant
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).
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.
Time frame: during implantation, at switch on( 4 weeks), after 3months and 6months.
Correlate the amplitude of ECAP with T & C levels.
Correlating the amplitude of ECAP with threshold and comfortable levels and creating a MAP.
Time frame: 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.
Time frame: 2 mins
Plan to share: No — Confidentiality regarding patient's participation in the study will be maintained throughout the study period as well as after completion of the study.
Ran from Feb 2018 to primary completion in Dec 2019, 22 months.
Of 82 non-industry interventional studies with no phase under Hearing Loss, Sensorineural, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's 22 months is below that.
Counting every sponsor, half of 162 studies reached it within 22 months; a quarter within 6 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jawaharlal Institute of Postgraduate Medical Education & Research