Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Hyperbaric OXygen therapy for ACute Acoustic Trauma; HOXACAT

The HOXACAT study is investigating a treatment called hyperbaric oxygen therapy for people who have experienced sudden hearing problems after being exposed to a very loud noise, a condition known as acute acoustic trauma. This therapy involves breathing pure oxygen in a special high-pressure chamber. The main goal of the study is to find out if this treatment can help to improve hearing on average across all affected sound frequencies within one month after the treatment. This is a Phase III study, meaning it's a large-scale trial aiming to confirm if this treatment is effective and safe before it might be considered more widely available for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Amsterdam UMC Stichting

Enrolment target

Start

24 Oct 2024

Acute acoustic trauma

What is this study about?

Imagine you've been exposed to a sudden, very loud noise – perhaps an explosion, a gunshot, or a powerful firework – and afterward, your hearing feels different or dull. This sudden hearing change after a loud noise is what doctors call 'acute acoustic trauma'. It can be quite concerning, and doctors are always looking for the best ways to help people recover their hearing.

This study, officially named HOXACAT, is exploring a specific treatment called hyperbaric oxygen therapy. You might have heard of it being used for other conditions. In simple terms, it involves sitting in a special chamber where you breathe pure oxygen in an environment where the air pressure is higher than normal. The idea is that this extra oxygen can get to your inner ear and help it heal after the shock of a loud noise.

We need to find out if this treatment is genuinely effective. The study is particularly interested in learning if, one month after treatment, people who received this therapy have better hearing on average across all the different sounds they struggled to hear. This 'Therapeutic confirmatory (Phase III)' stage means we're trying to get clear evidence about whether this treatment works and how well it works compared to other approaches or no specific treatment.

Key takeaways

The HOXACAT study tests pure oxygen therapy for sudden hearing loss.
It's for people whose hearing was damaged by a very loud noise.
The goal is to see if hearing improves after one month.
This is a large-scale study to confirm if the treatment works.
Adults 18 and over, both men and women, can be considered.

Who may be eligible?

To take part in this study, you generally need to be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are invited to participate.

Beyond these basic age and sex requirements, the most important factor is that you have recently experienced 'acute acoustic trauma'. This means your hearing loss must have started suddenly after being exposed to a very loud noise. The research team will have specific medical criteria to confirm if your hearing problem fits the study's requirements.

It's important to discuss your particular situation with the study doctors. They will be able to tell you if your individual health circumstances and the nature of your hearing loss make you a suitable candidate for this research.

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 recently experienced sudden hearing loss after a very loud noise?
Are you willing to attend appointments for special oxygen therapy?
Are you able to attend follow-up hearing tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have initial assessments to confirm that you meet all the requirements. This might involve detailed hearing tests and discussions about your health history. The main part of the treatment involves undergoing hyperbaric oxygen therapy, which means attending sessions where you breathe pure oxygen inside a special chamber. The exact number and duration of these sessions would be explained to you.

Throughout the study, you would likely have follow-up appointments, including more hearing tests to see how your hearing is responding. The main goal is to check your hearing levels one month after the treatment, but there might be other check-ups before and after this point. You'll be given a clear schedule of visits, what will happen at each, and the total time commitment required.

Potential risks and benefits

Taking part in a study like this means you might be among the first to benefit if the hyperbaric oxygen therapy proves to be effective for acute acoustic trauma. This could potentially lead to an improvement in your hearing. However, there are also potential risks associated with hyperbaric oxygen therapy, such as temporary ear discomfort or pressure changes, and in rare cases, more serious issues that the study team will explain in detail. You have the right 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
Netherlands

Common questions

What is 'acute acoustic trauma'?

It's sudden hearing loss or damage that happens after being exposed to a very loud noise, like an explosion or gunshot.

What is 'hyperbaric oxygen therapy'?

It's a treatment where you breathe pure oxygen in a special room where the air pressure is higher than normal.

Will I definitely get the oxygen treatment?

The study design will determine this; sometimes studies compare the treatment with a placebo or standard care, which will be fully explained to you.

How long will the study last for me?

The main part of the study focuses on your hearing one month after potential treatment, but the full duration of your involvement, including assessments and follow-ups, will be clearly outlined by the study team.

Do I have to pay to join the study?

No, you should not have to pay to participate in a clinical trial. All study-related treatments and assessments are typically covered by the research study.