The Babelfish Control study
Research type
Research Study
Full title
Developing a Continuous Non-invasive Intracranial Pressure Monitoring Device: The Babelfish Control Study.
IRAS ID
154564
Contact name
Tony Birch
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Research summary
Marchbanks Measurement Systems (MMS) Limited have developed a revolutionary non-invasive device to measure both intracranial and cochlear fluid pressures – the fluid pressures around the brain and within the inner ear. The technique is known as tympanic membrane displacement measurement.
Intracranial pressure (ICP) can be considered as the ‘sixth vital sign’ that is irrevocably linked to a person's well-being and life itself. It's measurement is a surgical procedure that remains in the realms of tertiary care specialist neurosurgical centres where it is used when the benefits outweigh the risks. The value of this measurement in general health care is yet to be realised due to the lack of a practical, risk-free measurement technique.
Tympanic membrane displacement measurement (TMD) is simple and safe and it has been shown to relate to the intracranial pressure. TMD has the potential to make ICP measurement commonplace in healthcare however there remain some technical challenges that need to be met before it can achieve broad adoption in clinical practice. One of these is the need for a more extensive normal reference range.
The Babelfish project is a collaborative venture between Marchbanks Measurement Systems and University Hospital Southampton NHS Foundation Trust that is funded by the UK Government Technology Strategy Board. It is addressing each one of the tecnological challenges in a series of linked studies. This is the control study; it will recruit a large number of healthy control subjects to provide a reference range for a "normal" TMD measurement.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1126
Date of REC Opinion
29 Aug 2014
REC opinion
Favourable Opinion