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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03352154
• Collaborator: Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (Other)
• Enrollment: 21
• Arm: 1
• Anticipated Duration (Months): 42.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Sensorineural; Deafness	Diagnostic Test: P300 - Auditory long latency potential	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.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.
• Masking: None (Open Label)
• Masking Description: Not Apply
• Primary Purpose: Diagnostic
• Official Title: Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants
• Actual Study Start Date: Nov 20, 2016
• Anticipated Primary Completion Date: Jun 4, 2020
• Anticipated Study Completion Date: Jun 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients with unilateral cochlear implants submitted to P300 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.	Diagnostic Test: P300 - Auditory long latency potential; Perform the P300 exams.

Outcome Measures

Primary Outcome Measures

1. Improvement of the P300 Responses after CI [06 months after CI]

   Improving the cognitive process on CI receivers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Prelingual hearing loss

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Sao Paulo
• Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Investigators

• Study Chair: Miguel Hyppolito, MD/PhD, Coordinator Health Auditory Care Program of the HCRP-FMRP-USP

Study Documents (Full-Text)

None provided.

More Information

Publications

• Groenen PA, Makhdoum M, van den Brink JL, Stollman MH, Snik AF, van den Broek P. The relation between electric auditory brain stem and cognitive responses and speech perception in cochlear implant users. Acta Otolaryngol. 1996 Nov;116(6):785-90.
• McPherson, D.L. Late potentials of the auditory system. San Diego: Singular Publishing Group; 1996.

• Responsible Party: Miguel Angelo Hyppolito, Head of Otolaryngology, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT03352154
• Other Study ID Numbers: 38224814.2.0000.5440
• First Posted: Nov 24, 2017
• Last Update Posted: Mar 31, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Miguel Angelo Hyppolito, Head of Otolaryngology, University of Sao Paulo: cochlear implant; Evoked Potential P300
• Additional relevant MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural

Study Results

No Results Posted as of Mar 31, 2020