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
University of Melbourne
200 participants
Feb 28, 2023
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
Plain Language Summary
Simplified for easier understanding
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 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)
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ACTRN12622001555741