AUDIBLE-S – a clinical trial for people with sudden hearing loss

A team of researchers and clinicians in London and Sheffield are looking for participants to take part in a clinical trial of a new drug treatment for sudden hearing loss.

Sudden onset sensorineural hearing loss (SSNHL) is an emergency condition, where there is a rapid loss in hearing, usually in one ear, either instantly or over the course of 3 days. Current treatments, steroid tablets or injections given as soon as possible after the start of hearing loss, help hearing recover in some patients but not all. There is therefore a need for new and better treatments.

Researchers in the company SENSORION have worked for years to develop a new drug taken as a tablet that may be effective in improving hearing in patients with SSNHL. A team at the Royal National Throat Nose and Ear Hospital and at Sheffield Hospital are now inviting people with SSNHL to take part in a clinical trial to test this new drug treatment.

Because the earlier SSNHL is treated the better the outcome is, it is very important that patients with SSNHL see an ENT Doctor as soon as possible.

Testing new treatments

New drugs must be tested in clinical trials. This drug has so far been tested in a small group of volunteers without hearing loss and has proven safe. Now the aim is to test the drug in a larger group of patients with SSNHL to see if the tablet is effective in improving their hearing.

The development of new treatments and testing in clinical trials is carefully watched over by the health regulatory authorities and requires their approval to proceed. This is in line with UK and EU law and best practice guidance that governs how clinical trials are designed and conducted.

Who can participate

The team are looking for people aged at least 18 years diagnosed with SSNHL. Patients can only participate if their hearing loss started within the previous 3 days of the initiation of the tested treatment. Patients will receive an urgent hearing test to check their hearing loss is sensorineural, in one ear only and of a minimum severity. People with hearing loss in both ears or a history of ear surgery (apart from grommets) are not eligible for the study.

Where and when it is taking place

The study, called AUDIBLE-S, started in April 2019 and is taking place at the Royal National Throat Nose and Ear Hospital (UCLH NHS Foundation Trust) and at Sheffield Hospital.

What taking part in the study involves

Participating in the AUDIBLE-S study will require time and commitment over 12 weeks. The study drug is a tablet that is taken by mouth (3 tablets twice daily) for 4 weeks. Participants will attend up to 6 appointments at the Royal National Throat Nose and Ear Hospital or at Sheffield Hospital for health checks and hearing tests at set times.

All potential participants will be provided with detailed information about the study, including the potential risks and benefits, so they can make an informed choice about whether to take part.

More information

If you think you are eligible for the study, and interested in taking part, please contact the telephone number/email address below.

This study is supported by the National Institute for Health Research (NIHR) Clinical Research Network and the NIHR University College London Hospitals NHS Foundation Trust (UCLH) Biomedical Research Centre.