Cochlear Nerve DiseaseECAPNCT00725998
Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users
An observational study of Cochlear Nerve Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked compound action potential (ECAP) of the auditory nerve represents an option to assess changes in auditory nerve responses and the interaction between the electrode and the neural tissue over time. Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Nerve Disease
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Jan 2005to Nov 2006
- Phase
- Observational
- 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 Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The ECAP characteristics have been analyzed in 13 children implanted younger than three years old.
This study selected only children implanted younger than three years old and followed them during their first year of CI use.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked compound action potential (ECAP) of the auditory nerve represents an option to assess changes in auditory nerve responses and the interaction between the electrode and the neural tissue over time.
Aim: To study ECAP in children during the first year of CI use.
Material and methods: The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. SERIES STUDY.
Descriptors:
Cochlear Implantation,cochlear nerve,child.
- Conditions
- Cochlear Nerve Disease
- Keywords
- Cochlear Implantation., Cochlear nerve., Child., study, ECAP, During, First year
- Medical subject headings
- Vestibulocochlear Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. Series Study Results: During the first year of CI use there was a significant statistical growth for the amplitude of N1 peak, in basal electrodes, between the second and third returns. There were not any significant differences obtained for N1 peak, latency, slope, neither for p-NRT nor recovery time, among the returns. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJan 2005
- Primary completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Nerve DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725998
- Sponsor's protocol ID
- CEP 039/2004
- Acronym
- ECAP
- Status last verified
- Jul 2008
- First submitted
- 28 Jul 2008
- Last updated
- 20 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT00725998
- Acronym / sponsor ID
- ECAP / CEP 039/2004
- Conditions
- Cochlear Nerve Disease
- Keywords
- Cochlear Implantation., Cochlear nerve., Child., study, ECAP, During, First year
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Nov 2006 (actual)
- First posted
- 31 Jul 2008 (estimated)
- 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.
Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked compound action potential (ECAP) of the auditory nerve represents an option to assess changes in auditory nerve responses and the interaction between the electrode and the neural tissue over time.
Aim: To study ECAP in children during the first year of CI use.
Material and methods: The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. SERIES STUDY.
Descriptors:
Cochlear Implantation,cochlear nerve,child.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. Series Study Results: During the first year of CI use there was a significant statistical growth for the amplitude of N1 peak, in basal electrodes, between the second and third returns. There were not any significant differences obtained for N1 peak, latency, slope, neither for p-NRT nor recovery time, among the returns. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The ECAP characteristics have been analyzed in 13 children implanted younger than three years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Nerve Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 20 Mar 2018.