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

Not Applicable

• Conditions: Deafness; Hearing Loss, Sensorineural
• Interventions: Diagnostic Test: P300 - Auditory long latency potential

• Registration Number: NCT03352154
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-11-20
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31
• Primary Completion: 2020-06-04
• Study Completion: 2020-06-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

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Exclusion Criteria

• Prelingual hearing loss

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with unilateral cochlear implants submitted to P300	P300 - Auditory long latency potential	Patients with unilateral cochlear implants, using the speech processor at least 6 months, submitted to P300 exam before CI surgery, on speech processor activation and after 06 months.

Primary Outcome Measures

Name	Time	Method
Improvement of the P300 Responses after CI	06 months after CI	Improving the cognitive process on CI receivers