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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:
ClinicalTrials.gov Identifier:
NCT00725998
First Posted: July 31, 2008
Last Update Posted: October 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT00725998


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

ClinicalTrials.gov Identifier: NCT00725998     History of Changes
Other Study ID Numbers: CEP 039/2004
First Submitted: July 28, 2008
First Posted: July 31, 2008
Last Update Posted: October 20, 2008
Last Verified: July 2008

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