Back to resultsIntracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intracochlear Dexamethasone
Intratympanic Dexamethasone
No additional drugs(control Group)
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Loss, Sensorineural focused on measuring cochlear implant, dexamethasone
Eligibility Criteria
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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
intracochlear dexamethasone application during cochlear implantation
intratympanic dexamethasone application during cochlear implantation
No drugs during cochlear implantation
Outcomes
Primary Outcome Measures
Electrode Impedance(Ohm)
All intra-operative impedance values will be acquired after surgery. They will be repeated in first and 3 rd months
Electrode thresholds(CL)
All intra-operative thresholds will be acquired after surgery. They will be repeated in first and 3 rd months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04397354
Brief Title
Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
Official Title
Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
Keywords
cochlear implant, dexamethasone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
intracochlear dexamethasone application during cochlear implantation
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
intratympanic dexamethasone application during cochlear implantation
Arm Title
Group 3
Arm Type
Sham Comparator
Arm Description
No drugs during cochlear implantation
Intervention Type
Drug
Intervention Name(s)
Intracochlear Dexamethasone
Other Intervention Name(s)
intracochlear
Intervention Description
intracochlear injection of dexamethasone with cochlear implantation
Intervention Type
Drug
Intervention Name(s)
Intratympanic Dexamethasone
Other Intervention Name(s)
intratympanic
Intervention Description
intratympanic injection of dexamethasone with cochlear implantation
Intervention Type
Drug
Intervention Name(s)
No additional drugs(control Group)
Other Intervention Name(s)
No drugs
Intervention Description
Control group: No drugs will be injected middle ear with cochlear implantation
Primary Outcome Measure Information:
Title
Electrode Impedance(Ohm)
Description
All intra-operative impedance values will be acquired after surgery. They will be repeated in first and 3 rd months
Time Frame
1-3 months
Title
Electrode thresholds(CL)
Description
All intra-operative thresholds will be acquired after surgery. They will be repeated in first and 3 rd months
Time Frame
1-3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fazil N Ardic, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The metadata will be shared by a public depository.
Learn more about this trial
Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
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