CompletedNot ApplicableInterventional

Non-invasive swallow assessment device

This study aims to develop a new, non-invasive device to detect swallowing difficulties (dysphagia) and if food or drink accidentally enters the airway (aspiration). Aspiration can be serious, especially for older people or those with conditions like stroke. Currently, detection often involves X-rays or cameras. The device attaches to your neck and records swallowing sounds. A computer then analyses these sounds to find patterns linked to aspiration. Researchers will compare the device's findings with traditional tests to see how accurate it is. If successful, this could lead to a comfortable, radiation-free way to screen for swallowing issues, potentially preventing serious health problems.

At a glance

Status

Completed

Phase

Not Applicable

Enrolment target

Start

09 Nov 2023

Estimated completion

25 Jun 2025

Suspected dysphagia and/or aspiration

What is this study about?

Swallowing can be a tricky business. Sometimes, especially as people get older or have certain health conditions like a stroke or Parkinson's disease, food or drink can accidentally go into the windpipe instead of the food pipe. This is called 'aspiration', and it can lead to serious chest infections like pneumonia and can even be life-threatening.

Currently, doctors often use X-rays or a small camera passed through the nose to see if someone is aspirating. These methods work, but they can be a bit uncomfortable or involve radiation. This study is excited about a new device that could offer a much simpler and safer way to check for aspiration. It sticks gently to the front of your neck and just listens to the sounds you make when you swallow.

A computer then analyses these sounds, looking for any patterns that suggest food or drink might be going to the wrong place. The researchers will compare what the device 'hears' with the results from standard X-ray or camera tests to see how accurate it is. The goal is to see if this new, comfortable device could, in the future, help doctors quickly and easily identify people who are at risk of aspiration, potentially preventing serious complications.

Key takeaways

This study is testing a new, non-invasive device for detecting swallowing problems.
The device listens to your swallowing sounds using sensors on your neck.
It aims to replace current methods that can involve X-rays or cameras.
Participation involves wearing the device during your existing swallowing test.
This research could lead to safer and more comfortable ways to check for aspiration.
There are no direct benefits to you, but you help advance medical knowledge.

Who may be eligible?

You might be able to take part in this study if you are 16 years old or older and are already scheduled to have a check-up for swallowing problems at Cambridge University Hospitals. This check-up would involve either an X-ray test called videofluoroscopy (VF) or a camera test called flexible endoscopic evaluation of swallow (FEES).

However, there are a few reasons why you might not be able to join. For example, if you have a breathing tube in your neck (tracheostomy), have had certain cancers in your head and neck area (not including specific skin, thyroid or salivary gland cancers), or have any open wounds or broken skin on the front of your neck, you wouldn't be able to participate. Also, if you know you're allergic to materials like polythene or acrylate, which are in parts of the device, you should not 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 aged 16 or over?
Are you having a videofluoroscopy (X-ray) or FEES (camera) test for swallowing issues?
Do you have good skin integrity on the front of your neck?
Do you not have a tracheostomy (breathing tube) in place?
Do you not have certain cancers of the head or neck?
Are you not allergic to polythene or acrylate?

Answer every question to see your result.

What does participation involve?

If you decide to take part, a member of the study team will first talk you through everything and answer any questions you have. If you're happy to proceed, you'll be asked to sign a consent form.

Before your regular swallowing test (either the X-ray or camera test), a small device will be gently attached to the front of your neck. It uses medical sticky tape and a soft elastic strap to hold it in place. Your swallowing test will then go ahead as planned. Once your test is finished, the device will be removed from your neck, and your involvement in the study will be complete. You'll also be asked to share your thoughts on what it was like to wear the device.

Potential risks and benefits

There are no direct personal health benefits from taking part in this study, but your contribution will help researchers develop better ways to care for others in the future. The device itself is considered safe and has been approved by the hospital's engineering team. It doesn't involve any extra radiation or invasive procedures beyond the tests you're already scheduled for. Occasionally, some people might find wearing the device a little uncomfortable. Very rarely, there's a small chance of skin irritation or an allergic reaction if you're sensitive to materials like polythene or acrylate. You are free to withdraw from the study at any time 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.

Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, United Kingdom

Common questions

What is dysphagia?

Dysphagia is the medical term for difficulty swallowing food or liquids.

What is aspiration and why is it serious?

Aspiration is when food or drink accidentally goes into your windpipe instead of your food pipe. It can lead to serious chest infections like pneumonia.

Will I have to do extra tests if I join?

No, you will not have any extra swallowing tests or extra radiation exposure beyond what you are already scheduled for as part of your normal care.

How long will I be involved in the study?

Your involvement in the study will only be for the duration of your scheduled swallowing test.

Who is paying for this research?

The study is funded by the Medical Research Council and the University of Cambridge.

How to find out more

Maximilian Nussbaumer

mn406@cam.ac.uk +44 (0)7955 746974 Official trial record

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