REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation (NCT05745155) | Clinical Trial Compass
CompletedNot Applicable
REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation
United Kingdom200 participantsStarted 2023-05-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUC at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment