AuthorisedTherapeutic confirmatory (Phase III)Interventional

SERORL Effect of aspirin and folic acid for sudden sensorineural hearing loss

This study, called SERORL, is investigating if aspirin and folic acid can help people who suddenly lose hearing in one ear. This type of hearing loss, known as Sudden Sensorineural Hearing Loss (SSNHL), happens quickly, usually within 72 hours. Researchers are looking at whether these treatments can improve hearing by measuring changes in hearing levels and how well people understand speech. They also want to see if these treatments improve quality of life and how well the balance system works. This is a large-scale study (Phase III), meaning it's a crucial step to confirm if these common medicines could be a helpful and safe treatment for SSNHL patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

142

Start

17 Oct 2025

occurs within a 72 hour window no other types of hearing loss as conductive forms of hearing impairment. 4. No history of fluctuating sensorineural hearing loss or otologic disease.

What is this study about?

Imagine one day your hearing suddenly gets much worse in just one ear, often within a few days. This is what doctors call Sudden Sensorineural Hearing Loss (SSNHL). It's a specific type of hearing loss where the problem is with your inner ear or the nerve connecting your ear to your brain, not a blockage or other issue with your outer or middle ear. It happens very suddenly, usually within 72 hours, and means you've lost a significant amount of hearing in at least three different sound frequencies.

Researchers are conducting this important study to see if commonly available medicines, aspirin and folic acid, can help people recover their hearing after SSNHL. Aspirin is known as a 'blood thinner' and can help with blood flow, while folic acid is a vitamin important for many body functions. The study aims to compare how well people recover their hearing when taking aspirin, folic acid, both, or a dummy pill (placebo).

This is a 'Phase III' study, which means it's a major step in testing new treatments. It's designed to confirm whether these treatments are effective and safe in a larger group of people before they might be recommended more widely. The hope is to find better ways to help people get their hearing back and improve their quality of life after this often distressing condition.

Key takeaways

A clinical trial is looking at aspirin and folic acid for sudden hearing loss.
The study focuses on sudden hearing loss in one ear.
It's a major study (Phase III) to confirm if these treatments are helpful.
Participation involves regular hearing checks and questionnaires over 6 months.
You might receive active medicine or a dummy pill.

Who may be eligible?

This study is looking for adults aged 18 and over, both men and women. You might be eligible if you've recently experienced sudden hearing loss in just one ear that fits specific criteria.

To join, your sudden hearing loss must have started unexpectedly and in one ear only, within the last 72 hours, and then you sought medical attention within 15 days of it starting. Your doctor must have confirmed it's a 'sensorineural' type of hearing loss, meaning it's an issue with your inner ear or hearing nerve. They'll also check that you don't have other unexplained nerve problems or other types of hearing loss involved, like conductive hearing loss where sound can't get to the inner ear properly.

You wouldn't be able to join if you have a history of hearing loss that comes and goes, or if you have certain other ear conditions. The research team will carefully review your medical history and test results to see if you're a good fit for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you experienced sudden hearing loss in only one ear?
Did your hearing loss start within the last 72 hours?
Did you seek help for your hearing loss within 15 days of it starting?
Has your doctor confirmed it's 'sensorineural' hearing loss?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full check-up to make sure the study is right for you. You would then be given either a daily dose of folic acid, or a dummy pill instead, along with either a daily dose of aspirin, or a dummy pill instead. This means some people will get both active drugs, some one active drug and one dummy, some different combinations, and some will receive two dummy pills. This is to fairly compare the effects of the treatments.

You would have several visits over six months. At these visits, doctors would check your hearing with tests (like those to measure how well you hear different sounds and understand speech), ask you to fill out questionnaires about your quality of life, and check your balance. These checks would happen at 15 days, 3 months, and 6 months after starting the study. The total time you'd be involved in the study would be about 6 months.

Potential risks and benefits

By taking part, you might benefit from closer monitoring of your hearing and general health, and you could be among the first to receive a potentially effective treatment for sudden hearing loss. However, there's also a chance you could receive a dummy pill and not the active drug. As with any medication, aspirin and folic acid can have side effects, which the study doctors will explain to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'Sudden Sensorineural Hearing Loss'?

It's a sudden loss of hearing in one ear, usually happening within 72 hours, where the problem is with your inner ear or the nerve that helps you hear.

What medicines are being studied?

The study is looking at low-dose aspirin and folic acid to see if they can help improve hearing recovery.

Will I know if I'm getting an active medicine or a dummy pill?

No, it's a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving until the study is over. This ensures fair and unbiased results.

How long does the study last?

If you join, you would be involved for about 6 months, with several check-up appointments during that time.

Can I leave the study at any time?

Yes, you are completely free to leave the study at any point, and it won't affect your ongoing medical care.