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.
TITLE: Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters with
external sensor technology in Covid-19.
DESIGN: First-In-Man and Feasibility study of the Senti Version 1 Device in Covid-19.
AIMS: To explore the acceptability and feasibility of a novel medical device for the remote
monitoring and evaluation of acoustic pathophysiological parameters in Covid-19. To
investigate usability and acceptability of the Senti data capture device, and to ensure
technical and practical functionality of the device in a real-world clinical scenario.
PRIMARY OUTCOMES: Device feasibility SECONDARY OUTCOMES: Length of time with the device in
situ. The ease with which patients can apply the device.
POPULATION ELIGIBILITY: Patients with covid-19 or suspected of having Covid-19 clinically,
being discharged home into the community after attending A&E.
DURATION: 3 Months. (Recruitment period: 2 months. Analysis and reporting: 1 month).
Device: Senti V1.0 Device
This device class I, CE marked garment, with a similar form to a T-Shirt, embedded with ten sensor modules encased in silicone; the device comes with a charging stand in the form of a clothes hanger. Depending on the outcome of this feasibility study, the device may, in the future, form part of a class IIb medical device system, when accompanied by cloud-based software to listen to both current and historically recorded breath sounds for each Senti patient. The Senti Version One device will be labelled clearly to indicate the device version, on the inside of the garment, conforming to the MDR.
The garment itself will be made from textile composite, including cotton, elastase, micromodel, spandex, and polyester. All other components (including electronic and other plastic components) will be entirely encased in medical-grade silicone.
Inclusion Criteria:
- Patients attending A&E with Covid-19 or suspected Covid-19, who are being discharged
from A&E into the community.
Exclusion Criteria:
- Patients unable to give their consent.
- Patients with a known sensitivity or allergy to any of the components of the device.
- Patients with any active implanted devices (such as pacemakers or vagal nerve
stimulators).
- Patients with existing pressure sores across the area this device would come into
contact (predominantly, across the thorax).
- Patients with significant cognitive impairment or limiting physical disabilities - to
the extent that they are not able to manage their own ADLs; except where sufficient
family or care support is available to manage the device functions (in which case, the
device may be used with caution).
Senti Tech
Liverpool, Merseyside, United Kingdom