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Clinical Trials/NCT03352154
NCT03352154
Unknown
Not Applicable

Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants

University of Sao Paulo0 sites21 target enrollmentNovember 20, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss, Sensorineural
Sponsor
University of Sao Paulo
Enrollment
21
Primary Endpoint
Improvement of the P300 Responses after CI
Last Updated
6 years ago

Overview

Brief Summary

Bilateral severe to profound hearing loss is a socially disabling handicap. Cochlear implants can be used to improve hearing in cases where conventional hearing aids are not effective. There are few studies about the long latency Auditory Evoked Potential (P300), in individuals with hearing loss and Cochlear Implant (CI) users. The aim of this project is to study the behavior of P300 in users of unilateral CI.

Detailed Description

Bilateral severe to profound hearing loss is a socially disabling handicap. Cochlear implants can be used to improve hearing in cases where conventional hearing aids are not effective. There are few studies about the long latency Auditory Evoked Potential (P300), in individuals with hearing loss and Cochlear Implant (CI) users. The aim of this project is to study the behavior of P300 in users of unilateral CI. Twenty patients with bilateral severe and/or profound post-lingual deafness, all submitted to CI surgery, will be evaluated. Patients will be evaluated through P300 testing on the day before CI surgery, on the day of device activation and 6 months after device use. It is hoped that this study can contribute to the understanding of the mechanisms of brain plasticity involved in the recovery of hearing function after CI surgery. There are few studies on the behavior of P300 in CI users and there are no studies showing how central stimulation occurs after device implantation, during the phases of pre CI, CI activation and 6 months after CI.

Registry
clinicaltrials.gov
Start Date
November 20, 2016
End Date
June 4, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miguel Angelo Hyppolito

Head of Otolaryngology

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Patients with post-lingual hearing loss undergoing cochlear implant surgery

Exclusion Criteria

  • Prelingual hearing loss

Outcomes

Primary Outcomes

Improvement of the P300 Responses after CI

Time Frame: 06 months after CI

Improving the cognitive process on CI receivers

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