Clinical trial NCT03352154: Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants
Official title: Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss, Sensorineural
Deafness
Keywords: cochlear implant
Evoked Potential P300
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
First posted: 2017-11-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Verify the alteration of the latency and amplitude of the P300 as markers of the cognitive response after Cochlear Implant Assist in prognosis after implantation cochlear implant.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Prelingual hearing loss

Primary outcomes:
measure: Improvement of the P300 Responses after CI
timeFrame: 06 months after CI
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Coordinator Health Auditory Care Program of the HCRP-FMRP-USP
name: Miguel Hyppolito, MD/PhD
role: STUDY_CHAIR
References:
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