Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
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|ClinicalTrials.gov Identifier: NCT03500718|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cochlear Hearing Loss||Device: Cochlear implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation|
|Actual Study Start Date :||February 26, 2018|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||November 30, 2019|
Experimental: Pediatric patients with bilateral sensorineural hearing loss
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. [ 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.
- Correlate the amplitude of ECAP with T & C levels. [ Time Frame: 2 years ]Correlating the amplitude of ECAP with threshold and comfortable levels and creating a MAP.
- Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively. [ Time Frame: 2 mins ]By correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500718
|Contact: Aparna Das, MS ENTemail@example.com|
|Contact: Arun Alexander, MS ENTfirstname.lastname@example.org|
|Puducherry, India, 605006|
|Contact: Aparna Das 9940962997 email@example.com|
|Contact: Arun Alexander 9443021595 firstname.lastname@example.org|
|Principal Investigator: Aparna Das|
|Sub-Investigator: Arun Alexander|