RecruitingNAINTERVENTIONAL

Hearing and Structure Preservation Via ECochG

This study, called PRESERVE, explores a new method for cochlear implant surgery. Cochlear implants help people with severe hearing loss. Sometimes, surgery can damage the delicate inner ear and cause you to lose any remaining natural hearing. This study checks if using a special monitoring technique, called ECochG, during surgery can help protect this natural hearing. Half of the patients will have surgery using this monitoring, which guides the surgeon to correct any potential damage. The other half will have standard surgery. By comparing both groups, researchers hope to find out if the new method can lead to better hearing preservation and understanding of speech after the implant.

At a glance

Status

Recruiting

Phase

Sponsor

Advanced Bionics AG

Enrolment target

102

Start

15 May 2024

Estimated completion

31 Dec 2026

Hearing Loss, Sensorineural Severe-to-profound Hearing Loss

What is this study about?

If you have severe to profound hearing loss, a cochlear implant can make a big difference, helping you hear much better. However, during the operation to put the implant in, the very delicate structures inside your ear can sometimes get slightly damaged. This damage might mean losing some of your natural hearing that you still had, which could be helpful even with the implant.

This study, called PRESERVE, wants to see if there's a better way to do this surgery to protect your remaining natural hearing. Doctors are using a technique called Electrocochleography (ECochG). Think of it like a very sensitive alarm system inside your ear during the operation. If this alarm goes off, it tells the surgeon that the inner ear might be getting stressed, and they can then make small adjustments to prevent damage.

We want to compare this new method with the standard way of doing cochlear implant surgery. By doing this, we hope to learn if using this special monitoring can lead to more people keeping their natural hearing after the implant, and possibly understanding speech even better. This could improve the overall results for patients and help more people benefit from their cochlear implants in the best possible way.

Key takeaways

Exploring a new way to protect natural hearing during cochlear implant surgery.
Compares standard surgery with surgery using special real-time monitoring.
Aims for better hearing preservation and speech understanding.
Participation involves routine surgery plus extra hearing tests and one additional scan.
You won't know which surgical approach you receive for the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and meet the usual requirements for getting a cochlear implant in the UK. This generally means you have severe to profound hearing loss in the ear that will get the implant. Specifically, your hearing in that ear should be quite poor, especially at important sound frequencies, but you should still have some hearing at low frequencies. Also, your hearing loss shouldn't have been present for more than 15 years in that ear, and it should have developed after you learned to speak.

There are also reasons why you might not be able to join. For example, if the internal structure of your ear is unusual, or if you have certain ear conditions like previous ear surgery or infections that could complicate the implant. If your hearing loss is caused by nerve problems, meningitis, or if you have very good hearing in your other ear, this study might not be suitable for you. Finally, you can't join if you've already had a cochlear implant or are taking part in another cochlear implant 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 over?
Do you meet the usual criteria for getting a cochlear implant?
Do you have severe to profound hearing loss in the ear to be implanted, but still some low-frequency hearing?
Did your hearing loss develop after you learned to speak?
Do you not have any unusual ear anatomy or serious ear conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly put into one of two groups. You won't know which group you're in, and neither will your doctors. One group will have their cochlear implant surgery with the special ECochG monitoring, which provides real-time guidance to the surgeon. The other group will have the standard surgery without this monitoring. All other parts of your surgery and aftercare will be the same.

Before your surgery, your natural hearing will be carefully measured. After your implant is switched on, you will have follow-up appointments at 3 and 6 months to measure your natural hearing again and see how well you understand speech with your cochlear implant. You'll also have an extra CT scan of your ear after the surgery, which will be compared to your scan before. The total duration of active participation and follow-up for this study will be around 6 months after your implant is activated.

Potential risks and benefits

Taking part in this study could potentially benefit you by helping to preserve your natural hearing, which might lead to better overall hearing results with your cochlear implant. However, there are no guarantees, and you might not experience any direct benefits. As with any surgery, there are always risks, and this study involves standard cochlear implant surgery, which carries its own risks, such as infection or damage to structures in the ear. Receiving the ECochG monitoring adds negligible risk, as it is a monitoring technique. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (7)

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

Universitair Ziekenhuis Gent
Verified postcode
Ghent, Belgium· Recruiting
Le Centre Hospitalier Régional Universitaire de Tours
Verified postcode
Tours, France· Recruiting
Universitätsklinikum Freiburg Klinik
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
Ospedale Martini
Verified postcode
Torino, Italy· Recruiting
World Hearing Center
Verified postcode
Warsaw, Poland· Recruiting
Hospital Universitario Clinico San Cecilio
Verified postcode
Granada, Spain· Recruiting
Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is ECochG?

ECochG is a special monitoring technique used during surgery that can tell doctors if the delicate parts of your inner ear are under stress, helping them guide the implant carefully.

Will I know if I'm getting the special monitoring?

No, you won't know which group you're in. This helps make sure the study results are fair and unbiased.

Will this study change my standard cochlear implant care?

Apart from the specific surgical technique being studied, all other aspects of your surgery and follow-up care will be the same as standard care.

How long will I be involved in the study?

You'll be involved for about 6 months after your cochlear implant is switched on, with a few extra hearing tests and an additional scan.

Can I leave the study early if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your ongoing medical care.

How to find out more

Unai Martinez de Estibariz, Mr

unai.martinez@advancedbionics.com +34666964128 Official trial record

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