NCT03352154

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3.5 years

First QC Date

November 20, 2017

Last Update Submit

March 30, 2020

Conditions

Hearing Loss, SensorineuralDeafness

Keywords

cochlear implantEvoked Potential P300

Outcome Measures

Primary Outcomes (1)

  • Improvement of the P300 Responses after CI

    Improving the cognitive process on CI receivers

    06 months after CI

Study Arms (1)

patients with unilateral cochlear implants submitted to P300

EXPERIMENTAL

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

Interventions

P300 - Auditory long latency potentialDIAGNOSTIC_TEST

Perform the P300 exams.

patients with unilateral cochlear implants submitted to P300

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prelingual hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • McPherson, D.L. Late potentials of the auditory system. San Diego: Singular Publishing Group; 1996.

    BACKGROUND

  • 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.

    PMID: 8973707BACKGROUND

  • 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.

    PMID: 2069187RESULT

  • 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.

    RESULT

  • 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.

    PMID: 8588653RESULT

  • 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.

    PMID: 9391625RESULT

  • 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.

    PMID: 15064663RESULT

  • 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.

    PMID: 10590970RESULT

  • 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.

    PMID: 15978485RESULT

  • 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.

    PMID: 9105451RESULT

  • 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.

    PMID: 21340183RESULT

  • 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.

    PMID: 15715067RESULT

  • 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.

    PMID: 10547481RESULT

MeSH Terms

Conditions

Hearing Loss, SensorineuralDeafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Miguel Hyppolito, MD/PhD

    Coordinator Health Auditory Care Program of the HCRP-FMRP-USP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Not Apply
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Otolaryngology

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 24, 2017

Study Start

November 20, 2016

Primary Completion

June 4, 2020

Study Completion

June 4, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Include researchers on the support team.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
2 years
Access Criteria
Free to all IPD.