Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

October 2, 2014 updated by: University of Sao Paulo General Hospital
The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • University of Sao Paulo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group
Cochlear Implantation
Device: Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Other Names:
  • Hybrid L24 Implant
Active Comparator: Dexamethasone
Cochlear implantation using topical dexamethasone
Device: Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Other Names:
  • Hybrid L24 Implant
Drug: Cochlear Implantation+dexamethasone
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
Other Names:
  • Hybrid L24 Implant
  • Dexamethasone (4mg/ml)
Active Comparator: Dexamethasone+Hyaluronic acid
Cochlear implantation using topical dexamethasone associated with hyaluronic acid
Device: Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Other Names:
  • Hybrid L24 Implant
Drug: 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
Other Names:
  • Hybrid L24 Implant
  • Dexamethasone (4mg/ml)
  • Hyaluronic acid (10mg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing thresholds
Time Frame: 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.
within the first 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Bernardo F Ramos, University of Sao Paulo General Hospital
  • Study Director: Rubens V Brito Neto, University of Sao Paulo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 24, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

October 3, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0297/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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