Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01588925
First received: April 24, 2012
Last updated: March 22, 2013
Last verified: March 2013
  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.


Condition Intervention Phase
Hearing Loss
Device: Cochlear Implantation
Drug: Cochlear Implantation+dexamethasone
Drug: Cochlear Implantation+dexamethasone+hyaluronic acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Hearing 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.


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.


Estimated Enrollment: 18
Study Start Date: November 2011
Estimated Study Completion Date: August 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control group Device: Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Other Name: Hybrid L24 Implant
Active Comparator: Dexamethasone 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 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588925

Locations
Brazil
University of São Paulo General Hospital
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Bernardo F Ramos University of São Paulo General Hospital
Study Director: Rubens V Brito Neto University of São Paulo General Hospital
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01588925     History of Changes
Other Study ID Numbers: 0297/11
Study First Received: April 24, 2012
Last Updated: March 22, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Cochlear implantation
Dexamethasone
Acid, Hyaluronic
Impedance

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Hyaluronic Acid
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014