Validation of PAT for pre-operative screening for OSA: A pilot (v1.0)
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: A pilot study. (version 1.0 Date 26.07.2019)
IRAS ID
252272
Contact name
Martin Stout
Contact email
Sponsor organisation
Manchester Metropolitan University
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
This is a pilot study which will inform the numbers of patients needed for a larger-scale validation of a device used for screening for obstructive sleep apnoea in patients who are planning to undergo bariatric (weight loss) surgery. The device of interest is the WatchPAT (300). This device uses changes in the arterial tone in skin, measured non-invasively with a small probe worn over the finger to detect sleep disturbances caused by breathing pauses characteristic of obstructive sleep apnoea. Although 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 obstructive sleep apnoea, 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 obstructive sleep apnoea severity, the apnoea hypopnoea index, determined from data collected by the WatchPAT 300, with the apnoea hypopnoea index determined by data from the routine clinical test (Embletta MPR).
In this pilot study, 10 patients who require a sleep study (using Embletta MPR) for screening for obstructive sleep apnoea prior to bariatric surgery as part of their routine clinical work-up will be invited to participate in this pilot study. 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. After the study, patients will be invited to complete a short feedback questionnaire rating their experience of using the WatchPAT 300 device.REC name
London - Central Research Ethics Committee
REC reference
19/LO/1658
Date of REC Opinion
5 Nov 2019
REC opinion
Favourable Opinion