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
About this trial
This is an interventional diagnostic trial for Hearing Loss, Sensorineural focused on measuring cochlear implant, Evoked Potential P300
Eligibility Criteria
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
NCT ID
NCT03352154
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
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
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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
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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
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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
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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
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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
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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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Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants
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