AcuPebble to remotely monitor patients with OSA on CPAP therapy v1
Research type
Research Study
Full title
The use of a novel wearable medical device (AcuPebble SA100) to remotely monitor patients with obstructive sleep apnoea (OSA) on continuous positive airway pressure therapy (CPAP)
IRAS ID
311874
Contact name
Swapna Mandal
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Obstructive sleep apnoea (OSA) is a common sleep-related respiratory health problem affecting about 1.5million adults in the UK. When patients with OSA sleep, their throat closes completely and the flow of air stops, meaning they stop breathing for a short period of time. This is called an apnoea. OSA leads to poor night-time sleep quality, increased daytime sleepiness, reduced quality of life as well as many medical conditions and a higher risk of road traffic accidents. Treatment is with continuous positive airway pressure (CPAP) therapy. CPAP is a simple machine that blows air through a mask to keep the airway open during sleep.
Sometimes, even when patients use CPAP, they may still have episodes where they stop breathing. The CPAP machine will automatically detect how many times patients have stopped breathing every hour that they sleep, and this is shown as a number. The idea being the lower the number the better their OSA is treated. However, different machines have different ways in detecting this, and evidence has shown that this not error-free. A full home sleep study is the best way to detect this but is not very practical as it involves many sensors to be placed on the body and so can be difficult to use.
Therefore, the main purpose of this study is to see whether a new wearable medical device called AcuPebble is better than the machine in detecting the number of times patients stop breathing while using CPAP. AcuPebble has already been shown to correctly detect these episodes when initially diagnosing OSA and patients have found it both comfortable and simple to use. By knowing exactly how many of these episodes patients are still getting on CPAP, their treatment could be changed or improved leading to better OSA treatment and improved quality of life.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0272
Date of REC Opinion
31 Aug 2022
REC opinion
Further Information Favourable Opinion