REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation

NCT05745155 | Completed

• 1 other identifier: Senti-REMAP-WEST-FLARE- v1.0
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• AUC at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment

  Area under the Receiver Operator Characteristic curve (AUC) for FLAREs at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment being initiated (such as antibiotics/steroids prescription). This outcome measure is clinically meaningful as this metric quantifies the performance of the system for reducing time-to-intervention in respiratory disease flareups by specific time intervals. Earlier intervention in respiratory disease flareups, in turn, will improve outcomes, reduce hospitalisations, and improve quality of life.

  12 weeks

Secondary Outcomes (11)

• Average time difference between FLAREs and change in treatment

  12 weeks

• FLAREs False Positive Rate

  12 weeks

• Device utilisation

  12 weeks

• Number of A&E attendances

  12 weeks

• Number of hospital admissions

  12 weeks

Study Arms (1)

Senti-Wear with Senti-AI

EXPERIMENTAL

Participants will wear the Senti-Wear smart garment up to twice per day (as tolerated) and complete a study journal detailing issues with the device and changes to their respiratory illness.

Device: Senti Wear device system with Senti-AI subsystem

Interventions

Senti Wear device system with Senti-AI subsystem DEVICE

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.

Senti-Wear with Senti-AI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD (on GP record is acceptable) and at least one COPD exacerbation requiring steroid prescription in the last three years

You may not qualify if:

• Participants with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own Activities of Daily Living; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).
• Participants with existing pressure sores across the thorax and/or torso.
• Participants under the age of 18.
• Participants with a height outside the range (150-189cm)
• Participants with a waist circumference outside the range (62-169cm)
• Participants with a known sensitivity or allergy to any of the components of the device.
• Participants unable to give their consent.

Sponsors & Collaborators

• Senti Tech Ltd: lead

Study Sites (1)

Senti Tech

Liverpool, Merseyside, L1 0AX, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sundeep Kaul, MB ChB

  Senti Tech Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants, clinicians, and the research team will be blinded to the device output FLARES until the end of the data collection period
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This question will be answered by a double-blinded, comparative, device efficacy investigation, comparing the standard of care with a virtual arm simulating care delivered by acting on FLAREs generated by the Senti-AI subsystem.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 27, 2023
• Study Start: May 20, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

GB (1)