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Study on the Effects of Intracochlear Triamcinolone Acetonide for Patients with Persistent Sudden Sensorineural Hearing Loss After Unsuccessful Conservative Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for sudden sensorineural hearing loss, a condition where a person experiences a rapid loss of hearing, usually in one ear. The treatment being tested is an injection of a medication called triamcinolone acetonide, which is delivered directly into the cochlea, the part of the inner ear responsible for hearing. This medication is known by the brand name Volon® A 40 mg-Kristallsuspension-Spritzampulle.

The purpose of the study is to evaluate how well this treatment improves hearing in patients who have not responded to other treatments, such as oral or ear injections of steroids. Participants in the study will receive either the triamcinolone acetonide injection or a placebo. The study will observe changes in hearing ability over a period of time, using tests that measure how well participants can hear different tones and understand speech.

Throughout the study, participants will undergo various hearing tests, including the pure tone audiometry, which measures the ability to hear sounds at different pitches, and speech tests to assess how well they can understand spoken words. The study aims to provide insights into the effectiveness of this treatment for those with persistent hearing loss after other therapies have failed.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.
You must meet specific criteria, such as being between 18 and 80 years old, having sudden sensorineural hearing loss (SSHL) within the last 21 days, and having not recovered after previous treatments.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your hearing condition. This includes measuring your hearing threshold, which is the quietest sound you can hear at different frequencies.
The assessment will determine if your hearing loss is suitable for the study, specifically if there is a mean hearing threshold shift of at least 30 decibels in three adjacent frequencies.
Step 3
Treatment administration
If eligible, you will receive an **intracochlear injection** of **triamcinolone acetonide**. This is a medication administered directly into the cochlea, the part of the inner ear responsible for hearing.
The medication used is called **Volon® A 40 mg-Kristallsuspension-Spritzampulle**, which is a suspension for injection.
Step 4
Post-treatment monitoring
After the treatment, your hearing will be monitored over a period of 30 days. This involves regular check-ups to assess any changes in your hearing ability.
Tests such as the pure tone audiometry will be used to measure your hearing function, and speech intelligibility tests will evaluate how well you understand spoken words.
Step 5
Final evaluation
On day 30 after the treatment, a final evaluation will be conducted. This will include measuring the mean hearing threshold shift in the frequencies most affected by SSHL.
Additional assessments will be performed to evaluate the intensity of tinnitus, quality of speech intelligibility, and your perception of your own health condition.

Who can join the trial?

6 criteria

Patients must be between 18 and 80 years old.
Patients must have experienced sudden hearing loss within the last 21 days.
Patients must have not recovered after trying standard treatments, which include taking steroids by mouth or through the ear.
Patients must have a hearing loss of at least 30 decibels (dB) in three nearby sound frequencies. Sound frequencies are measured in kilohertz (kHz), which is a unit of sound frequency.
Patients must have an average hearing loss of at least 70 decibels (dB) in the sound frequencies of 0.5, 1, 2, and 4 kHz.
Patients must agree to participate by signing a consent form.

Who cannot join the trial?

4 criteria

Patients who have not experienced sudden sensorineural hearing loss (a rapid loss of hearing in one or both ears) cannot participate.
Patients who have not tried and failed conservative therapy (non-surgical treatments) for their hearing loss cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population (such as children, pregnant women, or those unable to consent) cannot participate.

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Medical University Of Vienna
Vienna, Austria

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Investigated drugs

Triamcinolone acetonide is a type of medication known as a corticosteroid. It is used in this clinical trial to help reduce inflammation and swelling in the inner ear. The goal of using this medication is to improve hearing in patients who have experienced sudden hearing loss that has not improved with other treatments. By applying it directly into the cochlea, the part of the ear responsible for hearing, the medication aims to directly target the affected area and potentially restore some hearing function.

Triamcinolone Acetonide

What is already known about the treatment

Triamcinolone acetonide – This medication is administered directly into the cochlea, which is part of the inner ear, to treat sudden sensorineural hearing loss (SSHL) that has not improved with standard treatments. Currently, it is being studied in clinical trials to assess its effectiveness in improving hearing function. Triamcinolone acetonide is a corticosteroid, which means it works by reducing inflammation and suppressing the immune response at the molecular level. It is classified pharmacologically as a glucocorticoid, a type of steroid hormone.

Investigated diseases

Sudden Sensorineural Hearing Loss – Sudden sensorineural hearing loss is a rapid loss of hearing that occurs over a short period, typically within 72 hours. It affects the inner ear or the nerve pathways from the inner ear to the brain. The condition often presents as a noticeable decrease in hearing ability in one ear, accompanied by a feeling of fullness or pressure. Some individuals may also experience tinnitus, which is a ringing or buzzing noise in the affected ear. The exact cause is often unknown, but it may be related to viral infections, blood circulation issues, or immune system problems. The progression can vary, with some people experiencing spontaneous recovery while others may have persistent hearing loss.