STARFISH (CPMS 53517, IRAS 1004878)

UPDATED - 20/03/2025

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.

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.

Further information can be found on the study website.

https://www.birmingham.ac.uk/research/bctu/trials/renal/starfish

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

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

EMIS: Jodie Button – jodie.button@nihr.ac.uk

SystmOne: James Baslington - james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

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