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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Maximilian
Nussbaumer
mn406@cam.ac.uk
Matthew
Smith
mes39@cam.ac.uk
Matthew
Smith
mes39@cam.ac.uk
Symptoms and signs involving the digestive system and abdomen
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Swallowing difficulty, known as dysphagia, is a common medical condition that in some people may allow food or drink to pass the into the airway, a process known as aspiration. Aspiration is more common in older patients and those with neurological disorders such as cerebral palsy, stroke or Parkinson’s disease. Aspiration can lead to serious health complications such as pneumonia, and may cause death.
This study aims to test a new device that may be able to detect aspiration without being invasive or using radiation like current diagnostic methods. The study is trialling a device that is attached to the front of the neck to record sounds during swallowing. These sounds are then analysed by a computer to pick up features that suggest aspiration has occurred.
The study will test the device in patients already undergoing screening for aspiration using either x-rays (videofluoroscopy, VF) or a flexible camera passed through the nose (flexible endoscopic evaluation of swallow, FEES). Approximately 20 volunteering participants will have sounds recorded during swallowing by microphones in the device, and these sounds will be labelled as coming from healthy or unhealthy swallow (e.g. aspiration) using the results of the VF or FEES tests. A computer will then develop an algorithm to assess these sounds in a way that picks out important differences that relate to swallow safety. Our research will determine if this algorithm could be used to predict if a swallow is healthy or not based on what it sounds like.
We will assess how accurate the algorithm can be at detecting unhealthy swallows, to see if a bigger clinical trial should be conducted using the device. We will also collect feedback from patients and staff doing the testing, to determine if the device is comfortable for patients and easy to use.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Device;
You can take part if:
You may not be able to take part if:
- Tracheostomy in place or previous tracheostomy - Active or previously treated cancer of the aerodigestive tract in the head and neck (i.e. not including local thyroid, salivary and skin malignancy) - Loss of skin integrity over front of neck - Contact sensitivity or allergy to any external component of the worn device
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST and funded by Medical Research Council (MRC) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 57228
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