Hearing Loss, SensorineuralNCT03352154
Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants
A study testing P300 - Auditory long latency potential in people with Hearing Loss, Sensorineural and Deafness, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Deafness
- What is being tested?
- P300 - Auditory long latency potential
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2016to 4 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with post-lingual hearing loss undergoing cochlear implant surgery
Who cannot join
- Prelingual hearing loss
About this study
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.
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
- Hearing Loss, Sensorineural, Deafness
- Being tested
- P300 - Auditory long latency potential
- Keywords
- cochlear implant, Evoked Potential P300
- Medical subject headings
- Hearing Loss, Sensorineural, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P300 - Auditory long latency potentialDiagnostic test
Perform the P300 exams.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: P300 - Auditory long latency potential |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the P300 Responses after CI
Improving the cognitive process on CI receivers
Measured: 06 months after CI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start20 Nov 2016
- Primary completion4 Jun 2020 (estimated)
- Study completion4 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Miguel Angelo Hyppolito, University of Sao Paulo
- Investigators
- Miguel Hyppolito, MD/PhD, Study chair, Coordinator Health Auditory Care Program of the HCRP-FMRP-USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352154
- Sponsor's protocol ID
- 38224814.2.0000.5440
- Status last verified
- Mar 2020
- First submitted
- 20 Nov 2017
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Include researchers on the support team.
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 8973707Kileny 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 2069187Duarte 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 8588653Jordan 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 9391625Muhler 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 15064663Klem 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 10590970Kelly 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 15978485Diniz 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 9105451Calhau 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 21340183Beynon 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 15715067Okusa 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants
- ClinicalTrials.gov ID
- NCT03352154
- Acronym / sponsor ID
- 38224814.2.0000.5440
- Conditions
- Hearing Loss, Sensorineural, Deafness
- Keywords
- cochlear implant, Evoked Potential P300
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- 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
- Study start
- 20 Nov 2016 (actual)
- Primary completion
- 4 Jun 2020 (estimated)
- Study completion
- 4 Jun 2020 (estimated)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| patients with unilateral cochlear implants submitted to P300 | Experimental | Diagnostic Test: P300 - Auditory long latency potentialPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with post-lingual hearing loss undergoing cochlear implant surgery
Key exclusion criteria (1 listed)
- Prelingual hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P300 - Auditory long latency potentialPerform the P300 exams. | Diagnostic test | patients with unilateral cochlear implants submitted to P300 |
Primary outcome
Improvement of the P300 Responses after CI
Time frame: 06 months after CI
Improving the cognitive process on CI receivers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- BackgroundMcPherson, D.L. Late potentials of the auditory system. San Diego: Singular Publishing Group; 1996.
- Background: PubMed 8973707Groenen 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 publication: PubMed 2069187Kileny 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 publicationDuarte 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 publication: PubMed 8588653Micco 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 publication: PubMed 9391625Jordan 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 publication: PubMed 15064663Muhler 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 publication: PubMed 10590970Klem 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 publication: PubMed 15978485Kelly 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 publication: PubMed 9105451Diniz 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 publication: PubMed 21340183Calhau 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 publication: PubMed 15715067Beynon 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.
- Individual participant dataSharing planned: Yes. Include researchers on the support team.
Related trials for Hearing Loss, Sensorineural
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Hyppolito, MD/PhD study chair
Coordinator Health Auditory Care Program of the HCRP-FMRP-USP
Questions about this trial
What is this clinical trial studying?
A study testing P300 - Auditory long latency potential in people with Hearing Loss, Sensorineural and Deafness, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the P300 Responses after CI (time frame: 06 months after CI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352154, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.