Investigating a Wrist-sensor Oximeter to Screen for Sleep Apnoea.

Status Not yet recruiting

Clinical Trial Summary

The primary study objective is to investigate sensitivity and specificity of a wrist sensor pulse oximeter (the Oxitone Medical Oxitone 1000M device) to screen for obstructive sleep apnoea. This study will involve thirty participants attending a sleep centre suspected of suffering from obstructive sleep apnoea (case finding screening). The secondary objective is to assess patient convenience with the screening procedure.

Clinical Trial Description

This is an observational study to assess the sensitivity and specificity of a wrist sensor pulse oximeter (Oxitone Medical Oxitone 1000M) to identify obstructive sleep apnoea cases in patients referred to the London Sleep Centre (case finding screening, or case only study). The wrist sensor pulse oximeter streams data (pulse rate, heart rate variability (HRV), blood oxygen saturation levels (SPO2), actigraphy data and skin temperature data) to a software application using bluetooth connectivity to be stored in a securely encrypted database cloud for analysis. The investigators at the sleep centre will be masked when analysing the data from the wrist sensor pulse oximeter when deciding on diagnosis of obstructive sleep apnoea. Data from the wrist sensor oximeter device will be statistically compared with the data from a conventional PPG fingertip oximeter and Peripheral Arterial Tonometry device currently in use. The study outcome will be whether the wrist sensor pulse oximeter device could be used in patients to screen reliably for obstructive sleep apnoea. The study also will include patient feedback on convenience of the screening procedure. The study will not affect routine patient medical management and care for patients assessed at the sleep centre. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04018547
Study type	Observational
Source	Oxitone Medical Ltd.
Contact	Leon Eisen, PhD
Phone	+97278346731
Email	Leon.eisen@oxitone.com
Status	Not yet recruiting
Phase
Start date	September 17, 2019
Completion date	December 17, 2019

View Details

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