NCT04693091

Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Senti Tech Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to explore the acceptability and feasibility of a novel medical device system for remote monitoring of breath and heart sounds (replicating remotely, and in an easy-to-use garment, that which a clinician would do with their stethoscope to listen to a patient's chest, 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. 10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A\&E into the care of the community respiratory team. 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: 1. What is the feasibility of the Senti data-capture device? 2. Is this device usable in clinical practice? 3. What are the requirements to train patients to use the device? The investigators will also consider: 4. Does the device function technically and practically, in real-world clinical scenarios? 5. 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.

Detailed description

TITLE: Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters with external sensor technology. DESIGN: First-In-Man and Feasibility study of the Senti Version 1 Device. AIMS: To explore the acceptability and feasibility of a novel medical device for the remote monitoring and evaluation of acoustic pathophysiological parameters. - 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 being discharged home with community respiratory team support, after attending A\&E. DURATION: 3 Months. (Recruitment period: 2 months. Analysis and reporting: 1 month).

Conditions

• Respiratory Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-03-01
• Completion: 2021-04-01
• First posted: 2021-01-05
• Last updated: 2021-01-05

Locations

1 site across 1 country: United Kingdom