A randomised controlled trial of STeroid Administration Routes For Idiopathic Sudden sensorineural Hearing loss
INCLUSION CRITERIA
● Adults aged 18 years or over
● Diagnosis of new-onset ISSNHL- sensorineural hearing loss of 30 decibels (dBHL) or greater occurring within a 3-day period and including 3 contiguous pure-tone frequencies (out of 0.5, 1.0, 2.0, 4.0 kilohertz (kHz)) confirmed with a pure tone audiogram.
● Onset of hearing loss within four weeks prior to randomisation
● English spoken as a first or second language
EXCLUSION CRITERIA
● Identified cause for hearing loss (not idiopathic) e.g. Meniere’s
● Bilateral ISSNHL
● Received prior steroid treatment for the same episode of ISSNHL
● Medical contraindication to high dose systemic steroids
● Previous history of psychosis
● On oral steroid therapy for another condition
● Known adrenocortical insufficiency other than exogenous corticosteroid therapy
● Hypersensitivity to the active substance or to any of the excipients
● Has a systemic infection unless specific anti-infective therapy is employed
● Has ocular herpes simplex
● Has ipsilateral acute or chronic active middle ear disease (including acute otitis media, chronic suppurative otitis media and cholesteatoma, excluding dry perforation)
● Does not have the capacity to provide written informed consent
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