STARFISH

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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