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Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hearing Loss

Intervention: Cochlear Implantation (Device); Cochlear Implantation+dexamethasone (Drug); Cochlear Implantation+dexamethasone+hyaluronic acid (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Sao Paulo General Hospital

Official(s) and/or principal investigator(s):
Bernardo F Ramos, Principal Investigator, Affiliation: University of São Paulo General Hospital
Rubens V Brito Neto, Study Director, Affiliation: University of São Paulo General Hospital

Summary

The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation

Clinical Details

Official title: Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Hearing thresholds

Detailed description: Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection. In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults (greater than 18 years old) with severe/profound, bilateral sensorineural

hearing loss with indication of cochlear implantation.

- Hearing thresholds better than 80 dB in 125 Hz, 90 dB in 250Hz and 100 dB in 500,

1000, 2000, 3000 and 4000 Hz in at least 3 of these frequencies Exclusion Criteria:

- Malformation or cochlear ossification

- Developmental Disabilities

Locations and Contacts

University of São Paulo General Hospital, São Paulo, Brazil
Additional Information

Starting date: November 2011
Last updated: October 2, 2014

Page last updated: August 23, 2015

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