← Back to all trials
Not Yet Recruiting
NCT05745155
REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation
Conditions: COPD
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: Senti Tech Ltd
Location: United Kingdom
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.
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 yearsExclusion 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.
Source: ClinicalTrials.gov (NCT05745155). StuddyBuddy aggregates publicly available trial information.