Clinical trial NCT05745155: REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Senti Tech Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: AUC at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Average time difference between FLAREs and change in treatment
timeFrame: 12 weeks
measure: FLAREs False Positive Rate
timeFrame: 12 weeks
measure: Device utilisation
timeFrame: 12 weeks
measure: Number of A&E attendances
timeFrame: 12 weeks
measure: Number of hospital admissions
timeFrame: 12 weeks
measure: Total sum length of stay of any hospital admissions
timeFrame: 12 weeks
measure: Number of GP visits
timeFrame: 12 weeks
measure: Number of specialist respiratory appointments
timeFrame: 12 weeks
measure: Respiratory Symptomology
timeFrame: 12 weeks
measure: Usability
timeFrame: 12 weeks
measure: ADEs
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Senti Tech
state: Merseyside
Study officials:
affiliation: Senti Tech Limited
name: Sundeep Kaul, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: