Information for Participants

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 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.

This study will help to find out the best route to give steroids when treating patients with ISSNHL in the future. Whilst there may be no immediate benefits to you, the aim is to improve the future care for people with ISSNHL.

Both the tablet and injection forms of steroids used in this study are commonly used in the UK as the usual treatments for ISSNHL and so their safety is well established. Most patients will not experience side effects. Severe side effects from tablet steroid treatment are very rare. Mild side effects are more common but go away once the 7 day treatment is stopped.

More information can be found in the STARFISH Participant Information Sheet (PIS) v2.0, 07-Oct-2022 (PDF 760KB)

The trial is run by the University of Birmingham and is funded by the NIHR Health Technology Assessment (HTA) programme (NIHR131528). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The Clinical leads for the study are based at University of Cambridge.

At the moment we do not know how best to give steroids for ISSNHL and this study aims to find out which route of steroid treatment works best in improving hearing for patients with ISSNHL. This is a large study that will take place across the UK at around 75 hospitals and over several years. It will eventually involve around 525 patients like you.

We are inviting you to volunteer to be chosen at random to receive steroids in one of the three forms which are commonly used in the UK as the usual treatments for sudden hearing loss:

1. Tablets taken by mouth.
2. Injections through the ear drum (with local anaesthetic to numb the area) and into the middle ear space. From here, steroids are taken up into the inner ear.
3. Both tablets by mouth and injections through the ear drum.

The findings of this study will be made public. We expect to have these results in 2025. We would like to publish our results in medical journals, to help other doctors and medical staff to learn from the findings and for patients to benefit. If we are successful with this, the results will be published in an anonymous manner so you cannot be identified.

We also plan to inform all participants of the findings, highlighting where the results are expected to make a clinical difference. This process will include both written material and a video. The results will be made available on this website.

Your data will be retained for at least 25 years after the study finishes. If you withdraw from the study, we will keep the information we have already obtained but, to safeguard your rights, we will use the minimum personally-identifiable information possible. More information about how we will process your data can be found here.

Someone that has been identified by a medical team as having a sudden unexplained loss of hearing due to damage in the inner ear.

Someone that has had a sudden drop in hearing within the past four weeks where the cause is not known, which has been confirmed by a hearing test.

You will be invited to take part through your Ear Nose and Throat (ENT) doctor. You can check if your hospital is taking part on the recruitment page.