STARFISH Trial
Research type
Research Study
Full title
A randomised controlled trial of STeroid Administration Routes For Idiopathic Sudden sensorineural Hearing loss: The STARFISH Trial
IRAS ID
1004878
Contact name
James Tysome
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2022-000085-17
ISRCTN Number
ISRCTN10535105
Research summary
Sudden loss of hearing due to damage to the cochlea (an inner ear structure that senses sound and sends the information to the brain) can occur without an obvious cause, a rare condition described as idiopathic sudden sensorineural hearing loss (ISSNHL). This usually occurs in one ear, can range from a mild hearing loss to a completely deaf ear and can be difficult to come to terms with.
The recovery of hearing following ISSNHL may be helped by urgent treatment with steroids, and this is the normal treatment that doctors recommend for this condition. We think that steroids probably work by reducing inflammation in the inner ear, but crucially, we do not know if these work best given as tablets or an injection through the ear drum. We aim to find out by asking people with ISSNHL to be randomly chosen to have steroid treatment by mouth, injections into their ear, or both together. They will have a hearing test and fill in questionnaires before treatment and then six and twelve weeks later to see how well their hearing recovers.
One of the main problems with a trial like this is reaching patients with sudden hearing loss to encourage them to see their GP, and making sure their GPs refer them quickly for treatment. We will use a Facebook campaign to reach patients, and use education material and teaching sessions for GPs. We have worked with a group of patients who had sudden hearing loss to make sure that this research study is designed well and measures the issues that they felt were important. They thought it would be helpful to be able to test their hearing at home during the study, and we therefore included some optional extra hearing tests that can be performed online.
REC name
London - Harrow Research Ethics Committee
REC reference
22/LO/0532
Date of REC Opinion
8 Nov 2022
REC opinion
Further Information Favourable Opinion