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Completed

NCT Number: NCT05029011

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BRAEBON VTS

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.

Primary outcomes

  1. Oximetry - overnight comparison between the VTS and gold-standard PSG

    Time frame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

    Time spent with oxygen saturation >=90%, time spent with oxygen saturation <= 88%, number of desaturations of >3%

  2. Cardiac Rate (heart rate/pulse)

    Time frame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

    beats per minute

  3. Blood Pressure (BP)

    Time frame: evening and morning, in a 24 hour period

    mmHg

  4. Temperature (forehead)

    Time frame: evening and morning, in a 24 hour period

    degrees celcius

  5. Body position (PSG and MediByte Jr) and head position (VTS)

    Time frame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

    minutes spent supine, lateral and prone

  6. Respiratory rate

    Time frame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

    breaths per minute

  7. Identification of artifact

    Time frame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).

    e.g. movement

Secondary outcomes

  1. Develop guidelines for the VTS

    Time frame: Within 6 months

    After assessing the usability of the VTS in the sleep laboratory and remote use in the home.

Sponsors and collaborators

Lead sponsor

Helen S. Driver, PhD

Other

Collaborators

  • Braebon Medical Corporation
  • National Research Council, Canada

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2021
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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