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Clinical Trial Summary

The MediByte VTS is a low-cost, portable device that is being developed to take continuous and real-time vital sign measurements of COVID-19 patients, both in the hospital and home setting. This study is being undertaken to test the MediByte VTS and validate against industry standards.


Clinical Trial Description

In response to the COVID-19 pandemic, the MediByte Vital Signs Monitor (VTS) has been developed with funding from the National Research Council of Canada Industrial Research Assistance Program through the federal government's Innovative Solutions Canada (ISC) program. The VTS will measure peripheral capillary oxygen saturation (SpO2) and pulse via photoplethysmography (PPG), temperature, blood pressure (BP), heart and respiration rates, electrocardiogram (ECG), head position and movement over a continuous period. This monitor can be used remotely, and importantly will be low-cost so it can be accessed widely. Data from the VTS is transmitted wirelessly to a portable basestation which is a smartphone or tablet device via a customized application. This study will test the VTS both within the clinical environment and in the remote home environment to see how well it monitors patients effected by COVID-19 needing care, as well as satisfying an unmet need for remote monitoring across the healthcare system. This study will compare the newly developed VTS with an industry gold standard of polysomnography (PSG) in the sleep laboratory, or in the home with the MediByte Jr (home sleep apnea test). Approximately 150 patients will be recruited to the study across two different settings which includes a hospital setting and a remote setting, within the home environment. ;


Study Design


NCT number NCT05029011
Study type Observational
Source Queen's University
Contact Helen Driver, Phd
Phone 613-548-2300
Email [email protected]
Status Not yet recruiting
Phase
Start date September 2021
Completion date March 2022