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Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Sponsor
Pamukkale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04397354
Collaborator
(none)
21
Enrollment
1
Location
3
Arms
30.6
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intracochlear Dexamethasone
  • Drug: Intratympanic Dexamethasone
  • Drug: No additional drugs(control Group)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, randomizedProspective, randomized
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
Actual Study Start Date :
Mar 2, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Sep 20, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Electrode Impedance(Ohm) [1-3 months]

      All intra-operative impedance values will be acquired after surgery. They will be repeated in first and 3 rd months

    2. Electrode thresholds(CL) [1-3 months]

      All intra-operative thresholds will be acquired after surgery. They will be repeated in first and 3 rd months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pamukkale University Denizli Turkey 20070

    Sponsors and Collaborators

    • Pamukkale University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fazıl Necdet Ardıç, Prof.Dr., Pamukkale University
    ClinicalTrials.gov Identifier:
    NCT04397354
    Other Study ID Numbers:
    • 2
    First Posted:
    May 21, 2020
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fazıl Necdet Ardıç, Prof.Dr., Pamukkale University
    cochlear implant
    dexamethasone
    Additional relevant MeSH terms:
    Hearing Loss
    Hearing Loss, Sensorineural
    Dexamethasone
    Dexamethasone acetate
    BB 1101

    Study Results

    No Results Posted as of Jun 14, 2022