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NCT04397354 Clinical Trial

Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Hearing Loss, Sensorineural Clinical Trial

Official title:
Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04397354
Other study ID # 2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2020
Est. completion date September 20, 2022

Study information
Verified date June 2022
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date September 20, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Intracochlear Dexamethasone
intracochlear injection of dexamethasone with cochlear implantation
• Intratympanic Dexamethasone
intratympanic injection of dexamethasone with cochlear implantation
• No additional drugs(control Group)
Control group: No drugs will be injected middle ear with cochlear implantation

Locations
Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)
Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

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