NCT03500718

Brief 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 cochlear implantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

April 2, 2018

Last Update Submit

February 20, 2020

Conditions

Cochlear Hearing Loss

Keywords

cochlear implantthreshold of electrically evoked compound action potentialneural response telemetry

Outcome Measures

Primary Outcomes (1)

  • 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.

    during implantation, at switch on( 4 weeks), after 3months and 6months.

Secondary Outcomes (2)

  • Correlate the amplitude of ECAP with T & C levels.

    2 years

  • Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.

    2 mins

Study Arms (1)

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.

Device: Cochlear implant

Interventions

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).

Pediatric patients with bilateral sensorineural hearing loss

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children between 1 and 6 years of age undergoing cochlear implantation in JIPMER during the study period.

You may not qualify if:

  • Incomplete electrode array insertion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JIPMER

Puducherry, 605006, India

Location

Related Publications (2)

  • 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.

    PMID: 20634770BACKGROUND

  • van 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.

    PMID: 27804133BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
JUNIOR RESIDENT

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 18, 2018

Study Start

February 26, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Confidentiality regarding patient's participation in the study will be maintained throughout the study period as well as after completion of the study.

Locations

IN(1)