Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

NCT04397354 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Sensorineural

Keywords

cochlear implant; dexamethasone

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Group 1

ACTIVE COMPARATOR

intracochlear dexamethasone application during cochlear implantation

Drug: Intracochlear Dexamethasone

Group 2

ACTIVE COMPARATOR

intratympanic dexamethasone application during cochlear implantation

Drug: Intratympanic Dexamethasone

Group 3

SHAM COMPARATOR

No drugs during cochlear implantation

Drug: No additional drugs(control Group)

Interventions

Intracochlear Dexamethasone DRUG

intracochlear injection of dexamethasone with cochlear implantation

Also known as: intracochlear

Group 1

Intratympanic Dexamethasone DRUG

intratympanic injection of dexamethasone with cochlear implantation

Also known as: intratympanic

Group 2

No additional drugs(control Group) DRUG

Control group: No drugs will be injected middle ear with cochlear implantation

Also known as: No drugs

Group 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with cochlear abnormality
• Patients with auditory neuropathy

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Injection, Intratympanic

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Fazil N Ardic, MD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: Prospective, randomized

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 21, 2020
• Study Start: March 2, 2020
• Primary Completion: August 1, 2022
• Study Completion: September 20, 2022
• Last Updated: January 4, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)