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 and Evaluation of Covid-19 at Home
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Senti Tech Ltd
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Patient-rated device comfort
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed Description
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).
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Patient-rated device comfort
Time Frame: 1 month
Patient questionnaire "on a scale of 1 ("Very difficult to use") to 5 ("Very easy to use"), how easy to use is the device?"
Expert-rated device data quality
Time Frame: 1 month
An appropriately qualified person (with clinical experience of auscultation) to rate quality of data captured by the device, as compared subjectively against the quality that they typically expect from standard auscultation, on a scale of 1 ("Much poorer data quality \[than standard auscultation\]") to 3 ("equivocal data quality") to 5 ("Much higher data quality").
Adverse events and adverse device events
Time Frame: 1 month
The number of participants experiencing adverse events, both arising from use of the device or otherwise, will be reported. Adverse events will be categorised as unexpected or expected, serious or otherwise, device-related or un-related.
Patient-rated device acceptability
Time Frame: 1 month
Patient questionnaire "on a scale of 1 ("I would not approve at all") to 5 ("I would greatly approve and would like this to become standard practice"), to what extent would you approve of this device being used to enable clinicians to assess your heart and lung sounds as part of a telephone consultation?"
Patient-rated device ease of use
Time Frame: 1 month
Patient questionnaire "on a scale of 1 ("Too uncomfortable to use for more than an hours or so") to 5 ("As comfortable as a T-Shirt"), how comfortable is the device?"
Secondary Outcomes
- Time spent to train patients to use the device.(1 month)
- Pressure sore EPUAP grade(1 month)
- Length of time spent with the device on the patient.(1 month)
- Length of time taken for the patient to apply the device(1 month)