Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology in Covid-19

Not Applicable

• Conditions: Covid19
• Interventions: Device: Senti V1.0 Device

• Registration Number: NCT04695821
• Lead Sponsor: Senti Tech Ltd

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).

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01
• Study First Submitted: 2021-01-01
• Study First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Primary Completion: 2021-02
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Senti Arm	Senti V1.0 Device	In stage 1 of this study (6 patients), the patient will apply the device and complete the initial patient survey; questions are around usability, comfort (including feelings of pressure), and acceptability. The Investigator will record the time taken to apply the device. A brief 30 seconds of chest sounds will be recorded from each of the nine sensors on the device in three different settings: standing up, lying down, walking around. In stage 2 of this study (10 patients; 6 of whom would be re-recruited from the first stage), the participant will use the device at home over five days. The Investigator will assess the participant daily for any signs of pressure sores or complications from using the device (including topical allergic reactions). The participant will complete a daily survey. The participant is encouraged to remove the device and apply it at their discretion. The participant can opt-out of wearing the device at any stage.

Primary Outcome Measures

Name	Time	Method
Patient-rated device comfort	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	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	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	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	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 Outcome Measures

Name	Time	Method
Time spent to train patients to use the device.	1 month	Length of time taken to train patients to use the device, as measured by an investigator with a stop watch.
Pressure sore EPUAP grade	1 month	For those patients who develop pressure sores, the pressure sore will be graded using the European Pressure Ulcer Advisory Panel grading system from a grade of grade 1 through to grade 4, including unclassified gradings and moisture lesions. (Patients will be graded as "No pressure sores" if there are no pressure sores noted on examination).
Length of time spent with the device on the patient.	1 month	Length of time over which a patient has used the device, as measured using a structured, binned multiple-choice survey. This is a custom-made scale titled "In the past 24 hours, for how many hours have you worn the Senti device?" with a minimum value of 0 hours and a maximum value of 24 hours. 8 options which include a range of times are available for selection.
Length of time taken for the patient to apply the device	1 month	Length of time taken for the patient to put the device on, as measured by an investigator with a stop watch.

Trial Locations

Locations (1)

Senti Tech; 🇬🇧 Liverpool, Merseyside, United Kingdom