Cochlear Implants in Post-lingually Children: Results After 10 Years

Deafness Clinical Trial

Official title:

Cochlear Implants in Post-lingually Children: Results After 10 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400178
• Other study ID #: 186/2008
• 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

• Deafness
• Hearing Impairment
• Hearing Loss

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,