REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation (REMAPWESTFLARE)

Senti Tech

Status: Completed

Conditions: COPD

Treatments: Device: Senti Wear device system with Senti-AI subsystem

Study type: Interventional

Funder types: Industry

Identifiers

NCT05745155

Senti-REMAP-WEST-FLARE- v1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Senti-Wear with Senti-AI

Experimental group

Description:

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.

Treatment:

Device: Senti Wear device system with Senti-AI subsystem