What is this trial about?

In the EMERALD trial we want to test whether something called a remote microphone assistive listening device (ALD) helps to improve hearing in people with mitochondrial disease hearing loss.

This type of ALD can help with understanding speech especially in busy situations where there is a lot of background noise.

Who can take part? 

You can take part in the EMERALD trial if:

• You are aged between 16 and 70.
• You have been diagnosed with genetically confirmed mitochondrial disease.
• You have mitochondrial disease-related hearing loss.

If you use hearing aids, they will need to be compatible with trial device (Phonak).

If you don’t use hearing aids, you may still be eligible (you will be provided with a receiver device to use alongside the ALD).

What does taking part involve?                                                                     

The trial involves visiting the trial site in Newcastle for up to four visits over six months.

At the visits you will undergo tests of your hearing. You will also complete questionnaires about your hearing and lifestyle. Between visits we will ask you to use the ALD as part of your everyday life.

Before starting the trial, we will check that you are suitable to take part. This is a very small trial, which means that we can only include people with a certain type and severity of mitochondrial disease hearing loss.

If you are suitable to take part we will provide you with the ALD and instructions for use. We will also ask you to keep a record of when you use the device and where.

For the first four weeks of the trial you will use the device for two weeks and then not use it for the next two weeks (or vice versa).

After this initial four-week period you will use the device for a further five months. This means that you will be in the trial for a total of 24 weeks (six months).

At the end of the trial you will return to your usual mitochondrial clinical care.

Are there any risks or burdens?

You will need to visit the trial site in Newcastle on up to four occasions over a six-month period. We will arrange or pay for your travel to the site and will arrange overnight accommodation if needed.

You will also need to keep a record of when and where you use the device each day. To make this as easy as possible you will be able to provide this information online or on paper.

Who will benefit?

We cannot promise that taking part in the trial will help you personally. However, you may find that using the ALD improves your hearing especially in everyday situations and background noise.

If the results from this trial are positive we may look to do further, larger trials of ALD use in people with mitochondrial disease hearing loss.

How do I find out more?

If you are interested in taking part in the trial and would like to find out more, please contact the trial team:

by email: [email protected]

by phone: 0191 208 3105