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NCT01588925 Clinical Trial

Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01588925
Other study ID # 0297/11
Secondary ID
Status Completed
Phase Phase 2
First received April 24, 2012
Last updated October 2, 2014
Start date November 2011
Est. completion date January 2014

Study information
Verified date March 2013
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date January 2014
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Device:
• Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Drug:
• Cochlear Implantation+dexamethasone
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
• Cochlear Implantation+dexamethasone+hyaluronic acid
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array

Locations
Country Name City State
Brazil University of São Paulo General Hospital São Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hearing thresholds 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. within the first 6 months after surgery Yes
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