Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

Overview[ - collapse ][ - ]

Purpose The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation, impedance and neural response telemetry following cochlear implantation.
ConditionHearing Loss
InterventionDevice: Cochlear Implantation
Drug: Cochlear Implantation+dexamethasone
Drug: Cochlear Implantation+dexamethasone+hyaluronic acid
PhasePhase 2
SponsorUniversity of Sao Paulo General Hospital
Responsible PartyUniversity of Sao Paulo General Hospital
ClinicalTrials.gov IdentifierNCT01588925
First ReceivedApril 24, 2012
Last UpdatedMarch 22, 2013
Last verifiedMarch 2013

Tracking Information[ + expand ][ + ]

First Received DateApril 24, 2012
Last Updated DateMarch 22, 2013
Start DateNovember 2011
Estimated Primary Completion DateAugust 2013
Current Primary Outcome MeasuresHearing thresholds [Time Frame: within the first 6 months after surgery] [Designated as safety issue: Yes]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.
Current Secondary Outcome Measures
  • Electrical Impedance [Time Frame: within the first 6 months after surgery] [Designated as safety issue: Yes]Electrode impedance will be measured in the electrodes 1, 6, 11, 16 and 22 in the intraoperatory, 1 month, 3 months and 6 months after the surgery.
  • Neural response telemetry [Time Frame: within the first 6 months after surgery] [Designated as safety issue: Yes]Neural response telemetry will be measured in the electrodes 1, 6, 11, 16 and 22 in the intraoperatory.

Descriptive Information[ + expand ][ + ]

Brief TitleHearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Official TitleHearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Brief Summary
The objective of the present study is to investigate the effect dexamethasone and hyaluronic
acid have on hearing preservation, impedance and neural response telemetry following
cochlear implantation.
Detailed Description
Many efforts have been made to prevent residual hearing loss after cochlear implantation,
such as the developmente 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 TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionHearing Loss
InterventionDevice: Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Other Names:
Hybrid L24 ImplantDrug: Cochlear Implantation+dexamethasone
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
Other Names:
  • Hybrid L24 Implant
  • Dexamethasone (4mg/ml)
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)
Study Arm (s)
  • Experimental: Control group
  • Active Comparator: Dexamethasone
  • Active Comparator: Dexamethasone+Hyaluronic acid

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment18
Estimated Completion DateAugust 2013
Estimated Primary Completion DateFebruary 2013
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesBrazil

Administrative Information[ + expand ][ + ]

NCT Number NCT01588925
Other Study ID Numbers0297/11
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of Sao Paulo General Hospital
Study SponsorUniversity of Sao Paulo General Hospital
CollaboratorsNot Provided
Investigators Principal Investigator: Bernardo F Ramos University of São Paulo General HospitalStudy Director: Rubens V Brito Neto University of São Paulo General Hospital
Verification DateMarch 2013

Locations[ + expand ][ + ]

University of São Paulo General Hospital
São Paulo, Brazil