Clinical Evaluation of SenseGuard™ to Detect Respiratory Changes, During Home Monitoring of Subje… (NCT05119374) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of SenseGuard™ to Detect Respiratory Changes, During Home Monitoring of Subjects With High Risk of AECOPD.
Israel57 participantsStarted 2021-11-11
Plain-language summary
This is an observational, open labeled study. The study aims to evaluate the capability of SenseGuard™ (SG) non-invasive wearable device, to detect, post-hoc, early respiratory changes due to exacerbation by daily monitoring of subjects with COPD, at home.
Subjects with COPD, that were discharged following hospitalization due to AECOPD are most susceptible to experience another exacerbation during the first 6 months post admission. Hence, subjects that were discharged from the hospital due to AECOPD during the last 3 months are eligible to the study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged ≥18.
âś“. Diagnosed with COPD, 30%\< FEV1 \<80% predicated, or FEV1\>80% and FEV1/FVC \< 0.7
âś“. Discharged from the hospital during the last 3 months due to AECOPD.
âś“. Provision of signed and dated informed consent form.
âś“. Speak, read and understand either Hebrew, Arabic or English.
âś“. Able to understand study requirements and comply with study procedures.
âś“. Able to operate a tablet for SG measurement.
Exclusion criteria
âś•. Suffer from any physical or cognitive impairment that may affect subject's capability to operate the SG device properly.
âś•. Pregnant woman or nursing mother.
âś•. Severely ill with less than 12-month life expectancy
What they're measuring
1
Significant changes in SenseGuard device respiratory parameters (Ratio of Inhalation to exhalation time) can indicate for early exacerbation of COPD patient.