Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)
- Conditions
- COVID-19
- Interventions
- Device: BRAEBON VTS
- Registration Number
- NCT05029011
- Lead Sponsor
- Helen S. Driver, PhD
- Brief Summary
The BRAEBON 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 BRAEBON VTS and validate against industry standards.
- Detailed Description
In response to the COVID-19 pandemic, the BRAEBON 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- Patients requiring a sleep evaluation using polysomnography
- People referred to the sleep clinic
- Persons over the age of 18
- Unable and/or unwilling to consent
- No access to home WIFI (applicable to participants local to Kingston undertaking the study in the home setting)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients of the Sleep Disorders Laboratory BRAEBON VTS Monitoring vital signs
- Primary Outcome Measures
Name Time Method Oximetry - overnight comparison between the VTS and gold-standard PSG Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). Time spent with oxygen saturation \>=90%, time spent with oxygen saturation \<= 88%, number of desaturations of \>3%
Cardiac Rate (heart rate/pulse) Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). beats per minute
Blood Pressure (BP) evening and morning, in a 24 hour period mmHg
Body position (PSG and MediByte Jr) and head position (VTS) Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). minutes spent supine, lateral and prone
Temperature (forehead) evening and morning, in a 24 hour period degrees celcius
Identification of artifact Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). e.g. movement
Respiratory rate Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). breaths per minute
- Secondary Outcome Measures
Name Time Method Develop guidelines for the VTS Within 6 months After assessing the usability of the VTS in the sleep laboratory and remote use in the home.
Trial Locations
- Locations (1)
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada