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
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