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

NCT ID: NCT00725998

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cochlear Nerve Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Locations

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Universidade de São Paulo

Bauru, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CEP 039/2004

Identifier Type: -

Identifier Source: org_study_id

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