STARFISH: A randomised controlled trial of STeroid Administration Routes For Idiopathic Sudden sensorineural Hearing loss
The STARFISH Trial is aiming to recruit 525 participants with sudden hearing loss from 75 NHS hospital Ear, Nose and Throat (ENT) units treating idiopathic sudden sensorineural hearing loss (ISSNHL).
Run from the Birmingham Clinical Trials Unit at the University of Birmingham, the STARFISH trial is a randomised controlled trial of steroid administration routes for ISSNHL. The primary objective is to establish the relative effects and cost-effectiveness of oral, intratympanic or combined oral and intratympanic steroids as the first line treatment in ISSNHL, when used as first line management.
ISSNHL is the rapid onset of reduced hearing due to loss of function of the inner ear or hearing nerve. The cause (found in only 10-15% of participants) can include infection, trauma and medication. In most cases, the cause is unknown or ‘idiopathic’. ISSNHL is usually unilateral, has an incidence of 5-20 per 100,000 and can result in permanent and complete hearing loss, although spontaneous recovery is seen in 32-65% of cases. ISSNHL can have a profound impact on quality of life. The experience of ISSNHL has been described as ‘terrifying’ and ‘isolating’ and participants are motivated to try any treatment which may improve hearing recovery, even if invasive or time-consuming. People with ISSNHL usually see their GP fairly soon after symptom onset. Some visit A&E or an audiologist. If ISSNHL is suspected, urgent referral to ENT specialists for assessment and treatment is advised.
Evidence supports improved hearing recovery with early steroid treatment, via oral, intravenous or intratympanic routes, with a combination of oral and intratympanic steroids possibly leading to superior hearing recovery. Identification of the most clinically and cost-effective route of administration of steroids as first-line treatment for ISSNHL is a high priority research recommendation from NICE (National Institute for Health and Care Excellence) guidelines ‘Hearing loss in adults: assessment and management’.
END OF RECRUITMENT: 30 Nov 2026
EMAIL: STARFISH@trials.bham.ac.uk
WEB: www.birmingham.ac.uk/starfish
