Back to resultsHearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Primary Purpose
Hearing Loss
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Cochlear Implantation
Cochlear Implantation+dexamethasone
Cochlear Implantation+dexamethasone+hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Cochlear implantation, Dexamethasone, Acid, Hyaluronic
Eligibility 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
Sites / Locations
- University of São Paulo General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Control group
Dexamethasone
Dexamethasone+Hyaluronic acid
Arm Description
Cochlear Implantation
Cochlear implantation using topical dexamethasone
Cochlear implantation using topical dexamethasone associated with hyaluronic acid
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01588925
First Posted
April 24, 2012
Last Updated
October 2, 2014
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01588925
Brief Title
Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Official Title
Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Cochlear implantation, Dexamethasone, Acid, Hyaluronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm Description
Cochlear Implantation
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Cochlear implantation using topical dexamethasone
Arm Title
Dexamethasone+Hyaluronic acid
Arm Type
Active Comparator
Arm Description
Cochlear implantation using topical dexamethasone associated with hyaluronic acid
Intervention Type
Device
Intervention Name(s)
Cochlear Implantation
Other Intervention Name(s)
Hybrid L24 Implant
Intervention Description
Cochlear implantation using Hybrid L24 Implant
Intervention Type
Drug
Intervention Name(s)
Cochlear Implantation+dexamethasone
Other Intervention Name(s)
Hybrid L24 Implant, Dexamethasone (4mg/ml)
Intervention Description
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
Intervention Type
Drug
Intervention Name(s)
Cochlear Implantation+dexamethasone+hyaluronic acid
Other Intervention Name(s)
Hybrid L24 Implant, Dexamethasone (4mg/ml), Hyaluronic acid (10mg/ml)
Intervention Description
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array
Primary Outcome Measure Information:
Title
Hearing thresholds
Description
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.
Time Frame
within the first 6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernardo F Ramos
Organizational Affiliation
University of São Paulo General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rubens V Brito Neto
Organizational Affiliation
University of São Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo General Hospital
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
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