Sleep Apnoea Breathing Record Exploratory Study (SABRES)
Research type
Research Study
Full title
An exploratory study of a novel, low-cost sleep apnoea screening device to compare its capability to identify apnoeas and hypopneas with current standard sleep apnoea test devices.
IRAS ID
325682
Contact name
Ajit Thomas
Contact email
Sponsor organisation
University Hospitals of North Midlands NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
Summary of Research
During sleep, many people have times when they breathe shallowly or completely stop. If a person stops breathing for more than 10 seconds, this is called an ‘apnoea’. If shallow breathing lasts for more than 10 seconds, it is called a ‘hypopnoea’. If a person has these events frequently, it disrupts their sleep and they do not awake refreshed. It can also put strain on the heart, leading to cardiovascular conditions. These sleep disorders, usually called ‘Sleep Apnoea’, can be treated for most people using ‘continuous positive airways pressure’, CPAP.
Current tests for sleep apnoea, usually used at home, are expensive, complicated for patients to use and do not monitor actual breathing. The new test, called Apne-Scan, is very simple and will cost less than the standard tests. It just requires the user to wear a mask, similar to ones used for CPAP treatment, overnight and then returning the mask for data analysis. The Apne-Scan mask, developed with taxpayer funding, is fitted with a pressure sensor to monitor actual breathing.
People between the ages of 18-70 who have been referred to the sleep clinic at Royal Stoke University Hospital are eligible to participate in this exploratory study. They will wear the Apne-Scan mask at the same time as their standard overnight sleep apnoea test.
The breathing data collected by Apne-Scan will be analysed by Apnea-Tech Limited, the device manufacturers, so that it can be compared to the data captured by the standard sleep apnoea test.Summary of Results
Sleep apnoea (SA) is an under-diagnosed condition, which can lead to multimorbidity and societal costs. The current diagnostic devices are expensive, complicated for patients to use and complex to analyse. We conducted an exploratory study of a novel, low-cost, simple-to-use SA screening device to compare its capability to identify apnoea (A) and hypopnea with a current home sleep apnoea test (HSAT) (NOX T3).
40 Participants were recruited from a SA clinic from a UK NHS hospital. They were trained in the use of the HSAT, which they were given to use concurrently with ApneScan (AS) overnight at home. There was strong correlation between AHI score for the two devices (0.955) and excellent agreement for the proportion of severity of sleep apnoea categories (93%). The results of this exploratory study indicate that, with further refinement of the automated analysis of the respiratory signal, would help the diagnostic throughput in sleep clinics and reduce costs. Due to device design, it could also assess patient tolerance to therapy.REC name
HSC REC A
REC reference
23/NI/0158
Date of REC Opinion
4 Jan 2024
REC opinion
Further Information Favourable Opinion