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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05029011
• Other study ID #: DMED-2496-21
• Status: Completed
• Start date: February 7, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: August 2022
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Helen S. Driver, PhD	Braebon Medical Corporation, National Research Council, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	Blood Pressure (BP)	mmHg	evening and morning, in a 24 hour period
Primary	Temperature (forehead)	degrees celcius	evening and morning, in a 24 hour period
Primary	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).
Primary	Respiratory rate	breaths per minute	Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
Primary	Identification of artifact	e.g. movement	Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
Secondary	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