Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

Phase 2

Completed

• Conditions: Hearing Loss
• Interventions: Device: Cochlear Implantation; Drug: Cochlear Implantation+dexamethasone; Drug: Cochlear Implantation+dexamethasone+hyaluronic acid

• Registration Number: NCT01588925
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-05-01
• Primary Completion: 2013-02
• Status Verified: 2013-03
• Study Completion: 2014-01
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Cochlear Implantation+dexamethasone	Cochlear implantation using topical dexamethasone
Dexamethasone+Hyaluronic acid	Cochlear Implantation+dexamethasone+hyaluronic acid	Cochlear implantation using topical dexamethasone associated with hyaluronic acid
Control group	Cochlear Implantation	Cochlear Implantation
Dexamethasone	Cochlear Implantation	Cochlear implantation using topical dexamethasone
Dexamethasone+Hyaluronic acid	Cochlear Implantation	Cochlear implantation using topical dexamethasone associated with hyaluronic acid

Primary Outcome Measures

Name	Time	Method
Hearing thresholds	within the first 6 months after surgery	Hearing thresholds will be measured by audiometry in the frequencies 125, 250, 500, 1000, 2000 and 4000 Hz in the preoperatory, 1 month, 3 months and 6 months after the surgery.

Trial Locations

Locations (1)

University of São Paulo General Hospital; 🇧🇷 São Paulo, Brazil