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Trial record 1 of 1 for:    NCT05029011
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Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)

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ClinicalTrials.gov Identifier: NCT05029011
Recruitment Status : Completed
First Posted : August 31, 2021
Last Update Posted : August 26, 2022
Sponsor:
Collaborators:
Braebon Medical Corporation
National Research Council, Canada
Information provided by (Responsible Party):
Helen S. Driver, PhD, Queen's University

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.

Condition or disease Intervention/treatment
COVID-19 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.

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)
Actual Study Start Date : February 7, 2022
Actual Primary Completion Date : July 15, 2022
Actual Study Completion Date : July 15, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of who under the care of the sleep disorders lab
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05029011


Locations
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Canada, Ontario
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Helen S. Driver, PhD
Braebon Medical Corporation
National Research Council, Canada
Investigators
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Principal Investigator: Helen Driver, Phd Queen's University and Kingston Health Sciences Centre
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Responsible Party: Helen S. Driver, PhD, Dr. Helen S. Driver, Assistant Professor, Division of Respirology and Sleep Medicine, Dept. Medicine, Queen's University, Queen's University
ClinicalTrials.gov Identifier: NCT05029011    
Other Study ID Numbers: DMED-2496-21
First Posted: August 31, 2021    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases