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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01400178
Other study ID # 186/2008
Secondary ID
Status Completed
Phase N/A
First received July 19, 2011
Last updated October 28, 2016
Start date November 2009
Est. completion date February 2011

Study information

Verified date October 2016
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- postlingually deaf

- age at cochlear implant: < 18 years

- more than 10 years of cochlear implant use

Exclusion Criteria:

- other disabilities

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Brazil Bionic Ear Center Sao Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

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