Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

January 1, 2023 updated by: Fazıl Necdet Ardıç, Pamukkale University
The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods. Participants who will have cochlear implant surgery will be divided into three groups. Group 1 will have intracochlear dexamethasone after the incision of the round window membrane. Group 2 will have intratympanic dexamethasone after the incision of the round window membrane. Group 3 will serve as a control group. All participants will be tested after a week, a month, 3, and 6 months. Impedance and threshold measurements will be compared.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

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

  • Turkey
      • Denizli, Turkey, 20070
        • Pamukkale University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with sensorineural hearing loss
  • Patients who will have cochlear implant surgery with CI422 electrode

Exclusion Criteria:

  • Patients with cochlear abnormality
  • Patients with auditory neuropathy

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
intracochlear dexamethasone application during cochlear implantation
Drug: Intracochlear Dexamethasone
intracochlear injection of dexamethasone with cochlear implantation
Other Names:
  • intracochlear
Active Comparator: Group 2
intratympanic dexamethasone application during cochlear implantation
Drug: Intratympanic Dexamethasone
intratympanic injection of dexamethasone with cochlear implantation
Other Names:
  • intratympanic
Sham Comparator: Group 3
No drugs during cochlear implantation
Drug: No additional drugs(control Group)
Control group: No drugs will be injected middle ear with cochlear implantation
Other Names:
  • No drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrode Impedance(Ohm)
Time Frame: 1-3 months
All intra-operative impedance values will be acquired after surgery. They will be repeated in first and 3 rd months
1-3 months
Electrode thresholds(CL)
Time Frame: 1-3 months
All intra-operative thresholds will be acquired after surgery. They will be repeated in first and 3 rd months
1-3 months

Collaborators and Investigators

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

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Fazil N Ardic, MD, Pamukkale University

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 (Actual)

March 2, 2020

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

September 20, 2022

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 17, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 1, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The metadata will be shared by a public depository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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