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

Primary Purpose

Hearing Loss, Sensorineural, Deafness

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
P300 - Auditory long latency potential
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hearing Loss, Sensorineural focused on measuring cochlear implant, Evoked Potential P300

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Prelingual hearing loss

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    patients with unilateral cochlear implants submitted to P300

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Improvement of the P300 Responses after CI
    Improving the cognitive process on CI receivers

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2017
    Last Updated
    March 30, 2020
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03352154
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 20, 2016 (Actual)
    Primary Completion Date
    June 4, 2020 (Anticipated)
    Study Completion Date
    June 4, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss, Sensorineural, Deafness
    Keywords
    cochlear implant, Evoked Potential P300

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Masking Description
    Not Apply
    Allocation
    N/A
    Enrollment
    21 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with unilateral cochlear implants submitted to P300
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    P300 - Auditory long latency potential
    Intervention Description
    Perform the P300 exams.
    Primary Outcome Measure Information:
    Title
    Improvement of the P300 Responses after CI
    Description
    Improving the cognitive process on CI receivers
    Time Frame
    06 months after CI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with post-lingual hearing loss undergoing cochlear implant surgery Exclusion Criteria: Prelingual hearing loss
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miguel Hyppolito, MD/PhD
    Organizational Affiliation
    Coordinator Health Auditory Care Program of the HCRP-FMRP-USP
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Include researchers on the support team.
    IPD Sharing Time Frame
    2 years
    IPD Sharing Access Criteria
    Free to all IPD.
    Citations:
    Citation
    McPherson, D.L. Late potentials of the auditory system. San Diego: Singular Publishing Group; 1996.
    Results Reference
    background
    PubMed Identifier
    8973707
    Citation
    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. doi: 10.3109/00016489609137926.
    Results Reference
    background
    PubMed Identifier
    2069187
    Citation
    Kileny PR. Use of electrophysiologic measures in the management of children with cochlear implants: brainstem, middle latency, and cognitive (P300) responses. Am J Otol. 1991;12 Suppl:37-42; discussion 43-7.
    Results Reference
    result
    Citation
    Duarte Josilene Luciene, Alvarenga Kátia de Freitas, Costa Orozimbo Alves. Potencial cognitivo P300 realizado em campo livre: aplicabilidade do teste. Rev. Bras. Otorrinolaringol. [Internet]. 2004 Dec [cited 2015 May 02] ; 70( 6 ): 780-785.
    Results Reference
    result
    PubMed Identifier
    8588653
    Citation
    Micco AG, Kraus N, Koch DB, McGee TJ, Carrell TD, Sharma A, Nicol T, Wiet RJ. Speech-evoked cognitive P300 potentials in cochlear implant recipients. Am J Otol. 1995 Jul;16(4):514-20.
    Results Reference
    result
    PubMed Identifier
    9391625
    Citation
    Jordan K, Schmidt A, Plotz K, von Specht H, Begall K, Roth N, Scheich H. Auditory event-related potentials in post- and prelingually deaf cochlear implant recipients. Am J Otol. 1997 Nov;18(6 Suppl):S116-7.
    Results Reference
    result
    PubMed Identifier
    15064663
    Citation
    Muhler R, Ziese M, Kevanishvili Z, Schmidt M, von Specht H. Visualization of stimulation patterns in cochlear implants: application to event-related potentials (P300) in cochlear implant users. Ear Hear. 2004 Apr;25(2):186-90. doi: 10.1097/01.aud.0000120366.80555.2a.
    Results Reference
    result
    PubMed Identifier
    10590970
    Citation
    Klem GH, Luders HO, Jasper HH, Elger C. The ten-twenty electrode system of the International Federation. The International Federation of Clinical Neurophysiology. Electroencephalogr Clin Neurophysiol Suppl. 1999;52:3-6. No abstract available.
    Results Reference
    result
    PubMed Identifier
    15978485
    Citation
    Kelly AS, Purdy SC, Thorne PR. Electrophysiological and speech perception measures of auditory processing in experienced adult cochlear implant users. Clin Neurophysiol. 2005 Jun;116(6):1235-46. doi: 10.1016/j.clinph.2005.02.011. Epub 2005 Apr 26.
    Results Reference
    result
    PubMed Identifier
    9105451
    Citation
    Diniz Junior J, Mangabeira-Albernaz PL, Munhoz MS, Fukuda Y. Cognitive potentials in children with learning disabilities. Acta Otolaryngol. 1997 Mar;117(2):211-3. doi: 10.3109/00016489709117772.
    Results Reference
    result
    PubMed Identifier
    21340183
    Citation
    Calhau CM, Lima Junior LR, Reis AM, Capistrano AK, Lima Ddo V, Calhau AC, Rodrigues Junior Fde A. [Etiology profile of the patients implanted in the cochlear implant program]. Braz J Otorhinolaryngol. 2011 Jan-Feb;77(1):13-8. doi: 10.1590/S1808-86942011000100003.
    Results Reference
    result
    PubMed Identifier
    15715067
    Citation
    Beynon AJ, Snik AF, Stegeman DF, van den Broek P. Discrimination of speech sound contrasts determined with behavioral tests and event-related potentials in cochlear implant recipients. J Am Acad Audiol. 2005 Jan;16(1):42-53. doi: 10.3766/jaaa.16.1.5.
    Results Reference
    result
    PubMed Identifier
    10547481
    Citation
    Okusa M, Shiraishi T, Kubo T, Nageishi Y. Effects of discrimination difficulty on cognitive event-related brain potentials in patients with cochlear implants. Otolaryngol Head Neck Surg. 1999 Nov;121(5):610-5. doi: 10.1016/S0194-5998(99)70067-7.
    Results Reference
    result

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