Clinical evaluation of a wearable sleep diagnosis technology
Research type
Research Study
Full title
Evaluation of performance of a novel wearable technology for diagnosis of sleep apnoea
IRAS ID
225818
Contact name
Mr Sanz-Pereira
Contact email
Sponsor organisation
Acurable Ltd
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
Sleep apnoea is a chronic respiratory condition that affects a significant percentage of the population (2%-24%) but is heavily underdiagnosed. Timely diagnosis is however important because delayed treatment is known to have huge financial, social and, most importantly, health, consequences. The main issue with diagnosing sleep apnoea is that, the only truly reliable method, involves patients attending an overnight study in a sleep clinic and wearing cumbersome and uncomfortable sets of sensors, whilst being continuously watched by a sleep nurse to correct for sensors’ de-attachment. This has to be followed by very time consuming human expert analysis of the signals obtained from these sensors. This method is hence very costly and hence can realistically only be offered to a small number of people. In addition, the obtrusiveness of the system, in combination with the fact that patients have to sleep in an unusual environment can lead to unusual sleep behaviours. The alternative to this is to carry out home monitoring using a pulse oximeter attached as a clip on the finger, with a wired connecting it to a recording box. This is still sub-optimal: the system is still uncomfortable for many patients; the human expert is still required to check the validity of the signals since artefact corruption is not unusual; in many cases tests have to be repeated because the sensor de-attach; and the output of oximetry contains no information on what type of event made oxygen saturation fall. The aim of this project is to clinically validate a sound based technology that aims to solve all of these problems: is very small, comfortable and trivial to use by patients themselves; does not suffer from de-attachment issues; provides automatic reliable diagnosis (no expert is needed at any point); and the output is different for different respiratory events.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/0308
Date of REC Opinion
17 Apr 2018
REC opinion
Further Information Favourable Opinion