A randomised controlled trial of STeroid Administration Routes For Idiopathic Sudden sensorineural Hearing loss: The STARFISH Trial (STARFISH)

Research summary

Hearing loss is a common and disabling condition that may result from problems with the cochlea,the inner ear structure that senses sound and sends information to the brain. Loss of hearing due to damage to the cochlea can occur suddenly and without an obvious cause,a condition described as sudden sensorineural hearing loss (SSNHL). SSNHL can range from a mild hearing loss to a completely deaf ear,which can make it difficult to understand people talking on the affected side. Recovery of hearing following SSNHL may be helped by urgent treatment with steroids,but crucially we do not know if these work best given as tablets or by an injection through the ear drum. If SSNHL is identified more than a few weeks after it occurs,steroids may have little effect. A major problem is that patients with SSNHL may not be referred to Ear,Nose and Throat (ENT) surgeons in time to benefit from steroid treatment (within four weeks),due to delays in the hearing loss being recognised or referred by general practitioners (GPs). Sudden hearing loss is rare and we usually do not know why it happens. Steroids are the best treatment to try and improve the hearing,but we do not know whether it is best to give them by mouth or by an injection through the ear drum. We aim to find out by asking people with sudden hearing loss of unknown cause to be randomly chosen to have steroid treatment by mouth,injection into their ear,or both together. They will have a hearing test and fill in questionnaires before treatment and then six weeks and three months later to see how well their hearing recovers,as well as measure their dizziness and ringing in their ears. 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 to their local Ear Nose and Throat department for treatment. We will use a Facebook campaign to reach people with sudden hearing loss and encourage them to see their GP. We will use teaching sessions to remind GPs to refer straight away to their local hospital ENT department. As these patients are usually seen by junior ENT doctors,we will use a national group of junior ENT doctors to let patients know about the trial. This group have already been very successful if previous work at recruiting patients to research studies. 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 that it would be a good idea to be able to test their hearing at home during the study as well as coming into the hospital for their hearing tests. We therefore included some hearing tests that can be performed on a smartphone,tablet or desktop computer at home for those patients who have one of these devices. The results of the research study will be shared with the public through our Facebook group,a website and newsletters as well as GPs,emergency doctors and ENT doctors through talks as meetings and changing guidelines for the treatment of sudden hearing loss.

Principal Investigator

Dr Samuel MacKeith

Contact us

Email: crndirectdeliveryteam@ouh.nhs.uk

IRAS number

1004878