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Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users (ECAP)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00725998
First received: July 28, 2008
Last updated: October 17, 2008
Last verified: July 2008
History of Changes
  Purpose

Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked compound action potential (ECAP) of the auditory nerve represents an option to assess changes in auditory nerve responses and the interaction between the electrode and the neural tissue over time.

Aim: To study ECAP in children during the first year of CI use.

Material and methods: The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. SERIES STUDY.

Descriptors:

Cochlear Implantation,cochlear nerve,child.


Condition
Cochlear Nerve Disease

Study Type: Observational
Official Title: Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Groups/Cohorts
1

The ECAP characteristics have been analyzed in 13 children implanted younger than three years old.

Series Study Results:

During the first year of CI use there was a significant statistical growth for the amplitude of N1 peak, in basal electrodes, between the second and third returns. There were not any significant differences obtained for N1 peak, latency, slope, neither for p-NRT nor recovery time, among the returns.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The ECAP characteristics have been analyzed in 13 children implanted younger than three years old.

Criteria

This study selected only children implanted younger than three years old and followed them during their first year of CI use.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725998

Locations
Brazil
Universidade de São Paulo
Bauru, SP, Brazil, 17012-900
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00725998     History of Changes
Other Study ID Numbers: CEP 039/2004
Study First Received: July 28, 2008
Last Updated: October 17, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Cochlear Implantation.
Cochlear nerve.
Child.
study
 ECAP
During
First year

Additional relevant MeSH terms:
Nervous System Diseases
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
 Ear Diseases
Otorhinolaryngologic Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on June 18, 2013