NCT05745155

REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation

Senti Remote Evaluation and Monitoring of Acoustic Pathophysiological Parameters with External Sensor Technology - FLAg for Review Efficacy Investigation: a Community-based Double-blinded Comparative Pivotal Clinical Efficacy Study to Investigate the Efficacy and Safety of a Novel Intelligent Wearable Medical Device System for the Autonomous Monitoring and Evaluation of Acoustic Pathophysiological Parameters in Order to Determine Clinical Deterioration and Flag Deteriorating Patients for Clinical Review, Reducing Time-to-intervention in Respiratory Disease Flareups

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Senti Tech Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical investigation is to explore the efficacy and economics of a novel medical device system which, through the remote monitoring and evaluation of acoustic pathophysiological parameters in long-term respiratory conditions, flags patients who are beginning to deteriorate for clinical review, in order to reduce time-to-intervention in respiratory disease flareups. The main question it aims to answer are: Would the use of the Senti-AI and Senti-Wear Device System reduce time-to-intervention in respiratory disease flareups? Participants will wear the Senti-Wear device up to twice per day as tolerated for 12 weeks. The Senti-AI subsystem will generate FLAREs (flags for review) and these will retrospectively be compared to the standard of care to evaluate whether acting on the FLARES would have reduced time-to-intervention.

Detailed description

This clinical investigation seeks to establish whether or not the Senti-Wear device system with the Senti-AI subsystem is effective for autonomously monitoring people with long-term respiratory illness with COPD. The aim of this autonomous monitoring is to generate flags for review (FLARES) if the system detects a worsening (deterioration) in lung sounds which might indicate a worsening respiratory illness. If effective, this device system will enable people with long-term respiratory illnesses to receive earlier intervention in disease flare-ups, ensuring these patients are on the right medication at the right time, avoiding hospital admissions, and staying well at home. 200 patients with COPD will be recruited. The design of this study is comparative. All 200 participants will undertake patient-sought care as usual, where patients seek medical aid once starting to feel more unwell. Over a six-month period, we will collect data on what care is sought and when this changes treatment. Participants will also use the Senti-Wear device to capture their breath and heart sounds twice a day over this six-month period. Participants, clinicians, and the research team will be blinded to the device output FLARES until the end of the data collection period. At the end of the data collection period, we will compare this with Senti-AI FLARES, to determine whether acting on FLARES would have led to early intervention in disease flareups. The study activities will take place in the participants' own homes. The study will recruit around Manchester and Liverpool, UK. The study is being funded by Senti-Tech limited, the manufacturer of the Senti-Wear with Senti-AI device system.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Senti Wear device system with Senti-AI subsystem	This device is a smart garment, with a similar form to a T-Shirt, jacket or tabard, embedded with ten sensor modules (nine acoustic sensors, one kinetic sensor - all able to detect signals from the chest wall and underlying structures, including the lungs) encased in silicone; the device is charged via a charging port in the garment. The device has two modes of operation: recording mode and charging mode. The device is internally (battery) powered during recording mode and mains-powered during charging mode. The device is accompanied by cloud-based software to listen to both contemporaneous and historically recorded breath sounds, for each Senti patient. To use the device, the user puts the garment on (overhead, like a T-Shirt, before joining the back piece to the front like a tabard). Additionally, Senti-AI adds an anomaly burden score and an alert "flag for review" against each acoustic record for each patient.

Timeline

• Start date: 2023-05-20
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2023-02-27
• Last updated: 2024-12-04

Locations

1 site across 1 country: United Kingdom