Senti-REMAP-WEST-COV-1 - Version 1.5 [COVID-19]
Research type
Research Study
Full title
Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological signals With External Sensor Technology in Covid-19. A small-scale study to capture acoustic pathophysiological parameters, in the community, through a wearable device, and to evaluate the technical and practical feasibility of utilising this data as part of a medical device system for the monitoring of patients with suspected or confirmed Covid-19 at home.
IRAS ID
294220
Contact name
Paul Walker
Contact email
Sponsor organisation
Senti Tech Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for autonomously monitoring of breath and heart sounds in Covid-19 (detecting and monitoring the progression of Covid-19 pneumonitis, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. Healthcare resources have been stretched substantially by Covid-19. Devices which enable patients to be monitored at home and direct these precious resources to those who require them are needed more than ever.
10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A&E into the community, with Covid-19. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions:
What is the feasibility of the Senti data-capture device? Is this device usable in clinical practice? What are the requirements to train patients to use the device?
The investigators will also consider:
Does the device function technically and practically, in real-world clinical scenarios? What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores)?
These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals for Covid-19.
REC name
London - Hampstead Research Ethics Committee
REC reference
21/HRA/0028
Date of REC Opinion
14 Jan 2021
REC opinion
Favourable Opinion