RecruitingNAINTERVENTIONAL

Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction

This research is testing a specific procedure called 'balloon dilation of the Eustachian tube' to see if it helps people with a common ear problem called Eustachian tube dysfunction. This condition can cause blocked ears, pain, and muffled hearing. Currently, treatments like nasal sprays often don't work, and ear tubes have their own risks. The study wants to find out if this balloon procedure is better than a fake procedure, who it works best for, and if it's safe. If you take part, you might get the balloon procedure or a dummy one, and you'll have several check-ups and questionnaires over about a year.

At a glance

Status

Recruiting

Phase

Sponsor

University of Calgary

Enrolment target

Start

25 Jun 2023

Estimated completion

01 Dec 2025

Eustachian Tube Dysfunction Barotitis

What is this study about?

You might be reading this because you often have problems with your ears feeling blocked, painful, or you have muffled hearing. These issues often happen because a small tube in your ear, called the Eustachian tube, isn't working properly. This is known as Eustachian tube dysfunction. When this tube doesn't open and close as it should, air pressure can build up or drop in your middle ear, leading to discomfort. Sometimes, these symptoms are worse when there are changes in air pressure, like when flying.

Doctors have tried various treatments for this condition, such as nose sprays or decongestants, but these often don't fix the problem for good. Another option is putting small tubes in the ear, but this also has potential downsides. This study is exploring a newer treatment called 'balloon dilation of the Eustachian tube'. It involves gently expanding the Eustachian tube with a tiny balloon to help it work better. The main goal is to see if this procedure is more effective than doing nothing, understand which types of patients benefit most, and ensure it's a safe option.

This research is important because many people suffer from these ear problems, and current treatments aren't always effective. By comparing the balloon treatment to a “sham” (dummy) procedure, the researchers hope to clearly show whether it truly helps alleviate symptoms like ear pressure, pain, and hearing issues. They are also looking to identify specific factors that predict a good response to the treatment, which could help doctors decide if it's the right choice for individual patients in the future.

Key takeaways

This study evaluates a balloon procedure for clogged or painful ears.
It compares the balloon procedure against a dummy procedure.
Participation lasts about one year, with several follow-up checks.
The goal is to find out if the balloon procedure is safe and effective.
You might get the active treatment or a dummy one, with an option to cross over.

Who may be eligible?

This study is looking for adults aged 18 or older who have ongoing problems with their Eustachian tubes, causing symptoms like ear pain, pressure, muffled hearing, ringing, or clicking noises. These symptoms should have lasted for at least 3 months and haven't improved after trying at least 4 weeks of nasal steroid sprays or a course of steroid tablets.

They are also interested in people whose ear problems mainly happen with changes in air pressure (like when flying or diving), with symptoms that have been occurring for over a year and happen at least every four months. These specific symptoms should include pain, pressure, muffled hearing, ringing, cracking, or feeling clogged, and they should typically get better within three days of relieving the pressure. You should also have tried at least one other treatment like decongestants or earplugs for pressure relief.

However, some conditions would mean you can't join the study. For example, if you have a hole in your eardrum, an ear infection, certain uncontrolled health conditions like severe sinus problems, or have had recent head or neck surgery. If you've had similar ear procedures before or have specific ear drum issues, you also wouldn't be able to take part.

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 had ongoing ear symptoms (pressure, pain, muffled hearing) for at least 3 months that haven't improved with nose sprays?
Do you get ear problems mainly with changes in air pressure that have happened for over a year?
Do you not have a hole in your eardrum or an active ear infection?
Have you not had head/neck surgery recently or a similar ear procedure before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first agree to share your health information with the researchers. You would then be randomly assigned to either receive the 'balloon dilation of the Eustachian tube' procedure or a 'placebo' (dummy) procedure. The dummy procedure is designed to look and feel similar to the real one, but doesn't actually involve dilating the tube. If you have the dummy procedure, you would have the option to get the actual balloon dilation six weeks later.

Before any procedure, you'll have an initial visit where you'll complete several questionnaires about your ear symptoms and how they affect your daily life and overall well-being. The study team will also perform a physical check of your ears, do a test to see how your eardrum moves (called a tympanogram), and a hearing test. They'll also check how well you can equalise the pressure in your middle ear.

After the procedure, you'll need to attend follow-up appointments at 6 weeks, 24 weeks (about 6 months), and 52 weeks (about 1 year). At each of these follow-up visits, you'll repeat the same questionnaires and tests you did at the beginning to track any changes. The total duration of your active involvement in the study, including follow-up, would be approximately one year.

Potential risks and benefits

Taking part in any research study involves potential benefits and risks. A potential benefit of this study is that if you receive the balloon dilation procedure, it might help to improve your Eustachian tube dysfunction and relieve your uncomfortable ear symptoms, especially if other treatments haven't worked for you. However, there's no guarantee that the treatment will be effective, or you might be in the group that receives the dummy procedure first. Any medical procedure carries some risks, even minor ones, though the study is also aiming to confirm the safety of this balloon procedure. You will receive detailed information about all possible risks associated with the procedures before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Otology Clinic, Clinic 7A, South Health Campus
Verified postcode
Calgary, Canada· Recruiting
Sunnybrook Health Sciences Center
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is Eustachian tube dysfunction?

It's when the small tube that connects your middle ear to the back of your nose doesn't open or close properly. This can cause feelings of ear pressure, pain, or muffled hearing.

What is 'balloon dilation of the Eustachian tube'?

It's a procedure where a very small balloon is inserted into your Eustachian tube and gently inflated to widen it, aiming to help it work better.

Will I definitely get the balloon procedure?

You will be randomly assigned to either receive the balloon procedure or a 'dummy' procedure. If you get the dummy procedure, you'll have the option to receive the actual balloon procedure after 6 weeks.

How long will I need to be involved in the study?

Your involvement in the study, including all follow-up appointments, will last for about one year after your procedure.

What is a 'placebo procedure'?

It's a fake procedure that looks and feels like the real treatment but doesn't involve actually dilating the Eustachian tube. This helps researchers compare the real treatment fairly.

How to find out more

Jaimi Workun

jaimi.workun@albertahealthservices.ca 403-764-4755 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.