DeafnessNCT01400178
Cochlear Implants in Post-lingually Children: Results After 10 Years
An observational study of Deafness and Hearing Impairment, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Objectives: To assess a group of post-lingually children after 10 years of implantation with regard to speech perception, speech intelligibility, and academic/occupational status. Study Design: A prospective transversal study. Setting: Pediatric referral center for cochlear implantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deafness, Hearing Impairment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Feb 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The age at evaluation was 19,3 to 29,2 years. The age at cochlear implant surgery was 5,4 to 16,10 years. The etiology of the deafness was: meningitis (5), ototoxic (1), mumps (2) and unknown (2).
Who may be able to join
- postlingually deaf
- age at cochlear implant: < 18 years
- more than 10 years of cochlear implant use
Who cannot join
- other disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: To assess a group of post-lingually children after 10 years of implantation with regard to speech perception, speech intelligibility, and academic/occupational status.
Study Design: A prospective transversal study. Setting: Pediatric referral center for cochlear implantation. Patients: Ten post-lingually deafened children with Nucleus and Med-El cochlear implants.
Interventions: Speech perception and speech intelligibility tests and interview.
Main Outcome Measures: The main outcome measures were score of Hint sentences recognition (silence and noise), speech intelligibility scores(write-down intelligibility and rating scale scores) and academic/ occupational status.
- Conditions
- Deafness, Hearing Impairment
- Keywords
- cochlear implant, children, follow up, results
- Medical subject headings
- Deafness, Hearing Loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liege Franzini Tanamati, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400178
- Sponsor's protocol ID
- 186/2008
- Status last verified
- Oct 2016
- First submitted
- 19 Jul 2011
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear Implants in Post-lingually Children: Results After 10 Years
- ClinicalTrials.gov ID
- NCT01400178
- Acronym / sponsor ID
- 186/2008
- Conditions
- Deafness, Hearing Impairment
- Keywords
- cochlear implant, children, follow up, results
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Jul 2011 (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.
Objectives: To assess a group of post-lingually children after 10 years of implantation with regard to speech perception, speech intelligibility, and academic/occupational status.
Study Design: A prospective transversal study. Setting: Pediatric referral center for cochlear implantation. Patients: Ten post-lingually deafened children with Nucleus and Med-El cochlear implants.
Interventions: Speech perception and speech intelligibility tests and interview.
Main Outcome Measures: The main outcome measures were score of Hint sentences recognition (silence and noise), speech intelligibility scores(write-down intelligibility and rating scale scores) and academic/ occupational status.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The age at evaluation was 19,3 to 29,2 years. The age at cochlear implant surgery was 5,4 to 16,10 years. The etiology of the deafness was: meningitis (5), ototoxic (1), mumps (2) and unknown (2).
Key inclusion criteria (3 listed)
- postlingually deaf
- age at cochlear implant: < 18 years
- more than 10 years of cochlear implant use
Key exclusion criteria (1 listed)
- other disabilities
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 31 Oct 2016.
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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 Deafness and Hearing Impairment, 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?
The sponsor lists 3 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: finished, as of the sponsor's last update on 31 Oct 2016. 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 31 Oct 2016.