Clinical performance and accuracy of the Vital Signs medical device
Research type
Research Study
Full title
Assessing the clinical performance and accuracy of the Vital Signs medical device.
IRAS ID
272354
Contact name
Jacqueline Wren
Contact email
Sponsor organisation
Oxehealth Limited
Duration of Study in the UK
0 years, 1 months, 31 days
Research summary
This study will collect additional data on the performance of a non-contact vital signs measurement device which will be used to measure the pulse rate and breathing rate of healthy adult participants recruited from the general public. Written informed consent will be obtained from all participants. The study will not affect or alter any medical care of the participants. The non-contact device is already a CE-marked medical device; this additional data is to support further development and regulatory clearance in other territories.
Data collected using the non-contact device will be compared to reference data from a CE-marked wearable device worn by participants. The wearable device measures pulse rate from a finger-tip sensor and breathing rate from stretchable bands worn around the chest and abdomen.
The non-contact monitoring system will use a camera system fixed to a wall several metres from the participant to record their vital signs (pulse rate and breathing rate) while they are in the study room. The participant will be given instructions to perform normal activities such as sitting, lying in bed, and walking around in the room. The activities will not be strenuous or compromise the participants' comfort or dignity. The participant will spend up to two hours in the room, being supervised throughout by a researcher. The raw data will be stored securely.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1945
Date of REC Opinion
20 Dec 2019
REC opinion
Further Information Favourable Opinion