COVID-19NCT05029011
Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)
An observational study of COVID-19, run by Helen S. Driver, PhD at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- BRAEBON VTS
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 7 Feb 2022to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of who under the care of the sleep disorders lab
Who may be able to join
- Patients requiring a sleep evaluation using polysomnography
- People referred to the sleep clinic
- Persons over the age of 18
Who cannot join
- Unable and/or unwilling to consent
- No access to home WIFI (applicable to participants local to Kingston undertaking the study in the home setting)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- BRAEBON VTS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRAEBON VTSDevice
The BRAEBON VTS is a portable device that continuously monitors vital signs. Participants in the study will wear the BRAEBON VTS for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Patients of the Sleep Disorders Laboratory | Monitoring vital signs Receives: Device: BRAEBON VTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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
Measured: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
Blood Pressure (BP)
mmHg
Measured: evening and morning, in a 24 hour period
Temperature (forehead)
degrees celcius
Measured: evening and morning, in a 24 hour period
Body position (PSG and MediByte Jr) and head position (VTS)
minutes spent supine, lateral and prone
Measured: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
Respiratory rate
breaths per minute
Measured: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
Identification of artifact
e.g. movement
Measured: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
Secondary outcomes (1)
Develop guidelines for the VTS
After assessing the usability of the VTS in the sleep laboratory and remote use in the home.
Measured: Within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start7 Feb 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen S. Driver, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Braebon Medical Corporation, National Research Council Canada
- Responsible party
- Sponsor-investigator, Helen S. Driver, PhD, Queen's University
- Investigators
- Helen Driver, Phd, Principal investigator, Queen's University and Kingston Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029011
- Sponsor's protocol ID
- DMED-2496-21
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-cost Sensor System for COVID-19 Patient Monitoring: Validation of BRAEBON Vital Signs Monitor (VTS)
- ClinicalTrials.gov ID
- NCT05029011
- Acronym / sponsor ID
- DMED-2496-21
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Helen S. Driver, PhDUniversity, hospital or other
- Collaborators
- Braebon Medical Corporation, National Research Council Canada
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients of the Sleep Disorders Laboratory | – | Device: BRAEBON VTSMonitoring vital signs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of who under the care of the sleep disorders lab
Key inclusion criteria (3 listed)
- Patients requiring a sleep evaluation using polysomnography
- People referred to the sleep clinic
- Persons over the age of 18
Key exclusion criteria (2 listed)
- Unable and/or unwilling to consent
- No access to home WIFI (applicable to participants local to Kingston undertaking the study in the home setting)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRAEBON VTSThe BRAEBON VTS is a portable device that continuously monitors vital signs. Participants in the study will wear the BRAEBON VTS for 24 hours. | Device | Patients of the Sleep Disorders Laboratory |
Primary outcome
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%
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
Blood Pressure (BP)
Time frame: evening and morning, in a 24 hour period
mmHg
Temperature (forehead)
Time frame: evening and morning, in a 24 hour period
degrees celcius
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
Respiratory rate
Time frame: Up to 24 hours (Overnight - between lights-off and lights-on as for standard overnight sleep recordings).
breaths per minute
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
1 secondary outcome
Develop guidelines for the VTS
Time frame: Within 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Driver, Phd principal investigator
Queen's University and Kingston Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Helen S. Driver, PhD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.