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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

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