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Completed

NCT Number: NCT04397354

Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracochlear Dexamethasone

Drug

intracochlear injection of dexamethasone with cochlear implantation

Other names: intracochlear

Intratympanic Dexamethasone

Drug

intratympanic injection of dexamethasone with cochlear implantation

Other names: intratympanic

No additional drugs(control Group)

Drug

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

Other names: No drugs

Primary outcomes

  1. Electrode Impedance(Ohm)

    Time frame: 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)

    Time frame: 1-3 months

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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 21, 2020
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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