Status unknownNCT03352154Updated Mar 31, 2020

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

An interventional study of P300 - Auditory long latency potential in Hearing Loss, Sensorineural and Deafness, sponsored by University of Sao Paulo. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 21
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: All

Study summary

Read the 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.

Conditions studied

Hearing Loss, Sensorineural
Deafness

Browse trials for

Keywords

cochlear implant
Evoked Potential P300

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with post-lingual hearing loss undergoing cochlear implant surgery

Exclusion criteria

Exclusion Criteria:

Prelingual hearing loss

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 21 participants (estimated)

Study arms

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

Interventions

Diagnostic testP300 - Auditory long latency potential
Perform the P300 exams.

What researchers measure

Primary outcomes

Improvement of the P300 Responses after CI
Improving the cognitive process on CI receivers
Time frame: 06 months after CI

Study locations

No study locations are listed for this record.

References and documents

Publications

McPherson, D.L. Late potentials of the auditory system. San Diego: Singular Publishing Group; 1996.
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. PubMed 8973707 ↗
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. PubMed 2069187 ↗
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.
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. PubMed 8588653 ↗
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. PubMed 9391625 ↗
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. PubMed 15064663 ↗
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. PubMed 10590970 ↗
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. PubMed 15978485 ↗
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. PubMed 9105451 ↗
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. PubMed 21340183 ↗
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. PubMed 15715067 ↗
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. PubMed 10547481 ↗

Individual participant data

Plan to share: Yes — Include researchers on the support team.

Supporting information: Study protocol, Sap, Csr

Registry details

Key details

Study ID: NCT03352154
Lead 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
Responsible party: Miguel Angelo Hyppolito (Head of Otolaryngology, University of Sao Paulo) — Principal investigator
First posted: Nov 24, 2017
Start date: Nov 20, 2016
Primary completion: Jun 4, 2020 (estimated)
Completion: Jun 4, 2020 (estimated)
Last update: Mar 31, 2020

Study contacts

Miguel Hyppolito, MD/PhD

study chair · Coordinator Health Auditory Care Program of the HCRP-FMRP-USP

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hearing Loss→

Other studies from this sponsor

University of Sao Paulo

Start the discussion