Clinical trial NCT05029011: Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)
Official title: Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Braebon Medical Corporation
name: National Research Council, Canada
First posted: 2021-08-31
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of who under the care of the sleep disorders lab

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.

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)

Primary outcomes:
measure: Oximetry - overnight comparison between the VTS and gold-standard PSG
timeFrame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
measure: Cardiac Rate (heart rate/pulse)
timeFrame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
measure: Blood Pressure (BP)
timeFrame: evening and morning, in a 24 hour period
measure: Temperature (forehead)
timeFrame: evening and morning, in a 24 hour period
measure: Body position (PSG and MediByte Jr) and head position (VTS)
timeFrame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
measure: Respiratory rate
timeFrame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
measure: Identification of artifact
timeFrame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
Secondary outcomes:
measure: Develop guidelines for the VTS
timeFrame: Within 6 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University and Kingston Health Sciences Centre
name: Helen Driver, Phd
role: PRINCIPAL_INVESTIGATOR
References: