RecruitingPhase 4ACTRN12622001555741

Intratympanic Corticosteroid Therapy for Idiopathic Sudden Sensorineural Hearing Loss

A double-blinded randomized controlled clinical trial to examine the hearing outcome of intratympanic dexamethasone injection compared with placebo control in subjects who experienced a sudden onset of sensorineural hearing loss


Sponsor

University of Melbourne

Enrollment

200 participants

Start Date

Feb 28, 2023

Study Type

Interventional

Conditions

Summary

The project will investigate the efficacy of intratympanic injections of dexamethasone in combatting Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL). This is a prospective, cross-over, double blinded randomised controlled trial. Patients presenting to the Emergency Department with ISSNHL and who meet the eligibility criteria will receive two intratympanic (IT) injections to the effected ear - one within the first 14 days of hearing loss onset, and the other 14 to 21 days later. The first injection will contain either 24mg/ml of dexamethasone or a placebo, and the second injection will be the opposite of the first injection. It is hoped that the IT dexamethasone injection will improve the patient's hearing in the effected ear. All patients involved will be prescribed a course of the oral corticosteroid prednisolone as part of standard care in addition to the IT injections. The primary aim is to determine if 24mg/ml IT dexamethasone in the treatment of ISSNHL will improve hearing. Hearing tests and questionnaires will be administered prior to each IT injection to assess the patient's hearing and to evaluate if the timing of the dexamethasone injection has an impact on hearing recovery.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Sudden sensorineural hearing loss is a frightening condition where a person wakes up — or notices during the day — that their hearing has dramatically worsened in one ear, without any obvious cause. It is a medical emergency, and quick treatment is essential to give the best chance of recovery. The current standard care is oral corticosteroids (steroid tablets), but an additional approach called intratympanic injection — where a corticosteroid is injected directly through the eardrum into the inner ear — may offer additional benefit. This randomised crossover trial will test whether adding an injection of dexamethasone (a type of steroid) directly into the ear, in addition to the standard course of oral prednisolone, improves hearing recovery. Each participant will receive two injections at separate visits — one active drug and one placebo — with neither the patient nor the doctor knowing which is which. Hearing tests will be performed before each injection to track progress. You may be eligible if you have experienced a sudden, unexplained drop in hearing in one ear that began within the past 7 days, confirmed on a hearing test (at least a 20 dB loss across three frequencies), with no other neurological symptoms and no other explanation for the hearing loss. You would not be eligible if you have another identified cause of sensorineural hearing loss, a history of fluctuating hearing loss, or medical conditions that make steroid treatment unsafe, such as uncontrolled diabetes or high blood pressure.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will be randomised into one of two groups: A) Receives intratympanic (IT) injection of 24mg/ml dexamethasone to the effected ear within 14 days onset of hearing loss, followed by a place

Participants will be randomised into one of two groups: A) Receives intratympanic (IT) injection of 24mg/ml dexamethasone to the effected ear within 14 days onset of hearing loss, followed by a placebo injection 14 to 21 days after the initial injection. B) Receives placebo IT injection within 14 days of onset of hearing loss, followed by an IT injection of 24mg/ml dexamethasone 14 to 21 days after initial injection. All IT injections will be administered by an ENT surgeon within Royal Victorian Eye and Ear clinics. Participants in both groups will be prescribed a course of oral prednisolone tablets as standard treatment in addition to the IT injections. The duration of the oral prednisolone is 14 days for all participants. A dosage of 1mg per kg of bodyweight per day (with 75mg as the maximum daily dose) will be administered for the first 7 days, followed by tapering of the dosage for a further 7 days.


Locations(1)

The Royal Victorian Eye and Ear Hospital - East Melbourne

VIC, Australia

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ACTRN12622001555741