Non-invasive swallow assessment device
Research type
Research Study
Full title
Swallow Assessment Using a Multi-Channel Non-Invasive Device: A Feasibility Study
IRAS ID
323842
Contact name
Matthew Smith
Contact email
Sponsor organisation
University of Cambridge AND Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
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.
REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0606
Date of REC Opinion
13 Jul 2023
REC opinion
Favourable Opinion