Clinical trial NCT04693091: Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Disease
Keywords: medical device
remote monitoring
Lead sponsor: Senti Tech Ltd
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A pilot stage, exploratory, First-In-Human and traditional feasibility, interventional study of the Senti V1.0 device (CE marked, Class I device), involving 10 patients attending A\&E, who are being discharged into the care of the community respiratory team. 5 devices will be used, to cover a range of sizes from extra-small to extra-large.
Primary purpose: DEVICE_FEASIBILITY

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Patients attending A\&E who are being discharged from A\&E into the care of the community respiratory team.

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).

Primary outcomes:
measure: Patient-rated device acceptability
timeFrame: 1 month
measure: Patient-rated device comfort
timeFrame: 1 month
measure: Patient-rated device ease of use
timeFrame: 1 month
measure: Expert-rated device data quality
timeFrame: 1 month
measure: Adverse events and adverse device events.
timeFrame: 1 month
Secondary outcomes:
measure: Length of time spent with the device on the patient.
timeFrame: 1 month
measure: Length of time taken for the patient to apply the device
timeFrame: 1 month
measure: Time spent to train patients to use the device.
timeFrame: 1 month
measure: Pressure sore EPUAP grade
timeFrame: Through study completion, once per day.
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Senti Tech
state: Merseyside
Study officials:
References: