Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)

Study Overview
=================
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.

Official Title
-----------------
Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Device: BRAEBON VTS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring a sleep evaluation using polysomnography People referred to the sleep clinic Persons over the age of 18 Exclusion Criteria: Unable and/or unwilling to consent No access to home WIFI (applicable to participants local to Kingston undertaking the study in the home setting)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients of the Sleep Disorders Laboratory<br>Monitoring vital signs | Device: BRAEBON VTS<br>* The BRAEBON VTS is a portable device that continuously monitors vital signs. Participants in the study will wear the BRAEBON VTS for 24 hours.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oximetry - overnight comparison between the VTS and gold-standard PSG | Time spent with oxygen saturation >=90%, time spent with oxygen saturation <= 88%, number of desaturations of >3% | Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). | 
| Cardiac Rate (heart rate/pulse) | beats per minute | Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). | 
| Blood Pressure (BP) | mmHg | evening and morning, in a 24 hour period | 
| Temperature (forehead) | degrees celcius | evening and morning, in a 24 hour period | 
| Body position (PSG and MediByte Jr) and head position (VTS) | minutes spent supine, lateral and prone | Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). | 
| Respiratory rate | breaths per minute | Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). | 
| Identification of artifact | e.g. movement | Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop guidelines for the VTS | After assessing the usability of the VTS in the sleep laboratory and remote use in the home. | Within 6 months |