Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery

NCT03374514 | Unknown Phase 3 DMC

• 1 other identifier: 3233
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hearing is the ability to perceive sounds through the ear. If the transmission of sound is defective, the person suffers some degree of hearing loss. Cochlear Implants (CI) provide partial hearing by stimulating auditory nerve cells. The evaluation of the functionality of the CI is facilitated by several analysis tools, such as the clinical calibration software. This offers the possibility of measuring electrical impedances in the cochlea. The electrical impedance is the opposition to the current flow between two electrodes. It is composed of two main elements: resistance and reactance. The impedances in a cochlear implant are not stable over time. The value is minimal immediately after surgery, and increases progressively in the first 2 to 3 weeks after the procedure due to the immune response of the organism against a foreign body and the trauma of the array insertion. Several authors have suggested the use of topical or intravenous corticosteroids to decrease intracochlear fibrosis. The use of Dexamethasone could have a protective effect by reducing the initial inflammatory response, apoptosis, and delayed fibrosis, which could impact the impedance. There is limited evidence on the effect of intra-surgical topical corticosteroids on the impedance of the cochlear implant. The aim of this clinical trial is to evaluate the impact of topical dexamethasone on the electrical impedance of the cochlear implant, with special attention to the analysis of the capacitive component. It will be carried out through an experimental, prospective, randomized and double-blind study. Objective To determine whether the use of topical dexamethasone in a single dose applied in the tympanic cavity (middle ear) during cochlear implant surgery modifies the capacitive component of the electrical impedance of the electrodes in the cochlea before the activation of the cochlear implant. Material and methods A phase 3 clinical trial will be conducted. The design is a parallel, randomized, controlled and double-blind experimental study. Expected impact The use of local dexamethasone during cochlear implant surgery would decrease the inflammatory response, improving postoperative impedances.

Conditions

Sensorineural Hearing Loss; Cochlear Implant

Keywords

corticosteroids; Electric impedance

Outcome Measures

Primary Outcomes (3)

• impedance

  absolute value

  30 days

• impedance- C

  absolute value of the capacitive component

  30 days

• impedance- R

  absolute value of the resistive component

  30 days

Study Arms (2)

DEX

EXPERIMENTAL

Topical dexamethasone will be placed at a concentration of 20mg / ml in a single dose in the tympanic cavity of the middle ear through posterior tympanotomy in the cochlear implant surgery, paying special attention to the round window membrane completely submerged in the liquid, to the insertion of the electrode assembly

Drug: Dexamethasone

SF

PLACEBO COMPARATOR

Sterile isotonic saline solution will be placed in a single dose in the tympanic cavity of the middle ear through posterior tympanotomy during cochlear implant surgery, paying special attention to the fact that the round window membrane is completely submerged in the liquid, prior to insertion of the electrode array

Drug: Sterile isotonic saline solution

Interventions

Dexamethasone DRUG

instilation of the solution in the middle ear

DEX

Sterile isotonic saline solution DRUG

Sterile isotonic saline solution

SF

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are candidates to receive a uni or bilateral cochlear implant with diagnosis of severe neurosensory hearing loss.
• Ages between 12 months and 85 years.
• Evaluation of internal ear anatomy performed by tomography and resonance magnetic, where normal cochlea and internal auditory canals are evidenced normal.
• Patients in which any implant of the Cochlear company is used: CI512, CI522 or CI532 with chipset CIC4 or higher.
• Complete insertion of electrodes through round window, round window enlarged or cochleostomy, via posterior tympanotomy using the technique universally known as "minimally traumatic surgery"

You may not qualify if:

• Refusal to participate in the protocol or to informed consent
• Intra-surgical gusher (see below, section "definitions").
• Contraindication to receive dexamethasone
• Medical, imaging, psychological or social contraindications to receive a cochlear implant
• Surgical or anesthetic contraindications for cochlear implant surgery.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

HIBA

CABA, Buenos Aires, Argentina

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Dexamethasone

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Federico A. Di Lella, MD

CONTACT

541149581493; federico.dilella@hospitalitaliano.org.ar

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IP

Model Details: randomized, controlled and double-blind experimental study.

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 15, 2017
• Study Start: August 9, 2017
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 29, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

AR (1)