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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Device: BRAEBON VTS

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.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of who under the care of the sleep disorders lab

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients of the Sleep Disorders Laboratory; Monitoring vital signs	Device: BRAEBON VTS; The BRAEBON VTS is a portable device that continuously monitors vital signs. Participants in the study will wear the BRAEBON VTS for 24 hours.

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

Collaborators and Investigators

• Sponsor: Helen S. Driver, PhD
• Collaborators: Braebon Medical Corporation; National Research Council, Canada
• Investigators: Principal Investigator: Helen Driver, Phd, Queen's University and Kingston Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 7, 2022
• Primary Completion (ACTUAL): July 15, 2022
• Study Completion (ACTUAL): July 15, 2022

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (ACTUAL): August 31, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: DMED-2496-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No