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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-07

Study Completion Date

2022-07-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Patients of the Sleep Disorders Laboratory

Monitoring vital signs

BRAEBON VTS

Intervention Type DEVICE

The BRAEBON VTS is a portable device that continuously monitors vital signs. Participants in the study will wear the BRAEBON VTS for 24 hours.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No