Validation of PAT for pre-operative screening for OSA
Research type
Research Study
Full title
Validation of a device based on peripheral arterial tonometry (PAT) for assessment of obstructive sleep apnoea prior to bariatric surgery
IRAS ID
284509
Contact name
Gillian Twigg
Contact email
Sponsor organisation
Manchester Metropolitan University
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Research Summary
Obstructive sleep apnoea (OSA) is a common sleep-related condition, which causes patients to stop breathing in their sleep. It is particularly prevalent in patients who are overweight or obese. Because undiagnosed OSA could increase risk for patients having bariatric surgery, they are routienly screened beforehand. However, current screening tools are complex and cumbersome for patients to use. The study seeks to validate WAtchPAT 300 (a device which is designed to detect OSA by non-invasively measuring changes in the arterial tone in skin on the finger) in bariatric surgery patients. \n\nAlthough this device has been validated against the accepted gold standard and is in routine use in the NHS for screening of obstructive sleep apnoea in uncomplicated patients with a high degree of clinical suspicion of OSA, validation studies have not included patients in the weight range typically seen in patients planning bariatric surgery. The study will compare the standard measure of OSA severity, the apnoea hypopnoea index (AHI), determined from data collected by the WatchPAT 300, with the AHI determined by data from the routine clinical test (Embletta MPR). \n\nA sample size calculation from a pilot study showed that the required sample size is 53 patients. Participants will be asked to wear the WatchPAT 300 at the same time as the Embletta MPR during their clinical sleep study. The agreement between the apnoea hypopnoea index measured by each device worn simultaneously on the same night will be assessed. \n\n
Summary of Results
The study compared the results of a diagnostic test for obstructive sleep apnoea (WatchPAT) with a gold standard device in patients undergoing weight-loss surgery. Patients wore both devices currently and the outcome measure of interest was the apnoea hypopnoea index (AHI), a measure of the number of breathing pauses per hour of sleep. Both clinically and statistically significant differences were found between WatchPAT and the gold standard, WatchPAT consistently producing higher AHIs compared to the gold standard. The study was extended to include referrals from the general sleep clinic population to understand whether these differences were population-specific. Similar results were found in the general sleep clinic group, meaning that WatchPAT did not disproportionately over-estimate the AHI in bariatric patients.
REC name
Wales REC 3
REC reference
20/WA/0197
Date of REC Opinion
23 Jul 2020
REC opinion
Further Information Favourable Opinion