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

NCT05029011 | Completed

• 1 other identifier: DMED-2496-21
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (7)

• 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).

• 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).

• Blood Pressure (BP)

  mmHg

  evening and morning, in a 24 hour period

• Temperature (forehead)

  degrees celcius

  evening and morning, in a 24 hour period

• 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).

• Respiratory rate

  breaths per minute

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

• Identification of artifact

  e.g. movement

  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

  Within 6 months

Study Arms (1)

Patients of the Sleep Disorders Laboratory

Monitoring vital signs

Device: BRAEBON VTS

Interventions

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.

Patients of the Sleep Disorders Laboratory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of who under the care of the sleep disorders lab

You may qualify if:

• Patients requiring a sleep evaluation using polysomnography
• People referred to the sleep clinic
• Persons over the age of 18

You may not qualify if:

• Unable and/or unwilling to consent
• No access to home WIFI (applicable to participants local to Kingston undertaking the study in the home setting)

Sponsors & Collaborators

• Helen S. Driver, PhD: lead
• Braebon Medical Corporation: collaborator
• National Research Council, Canada: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Helen Driver, Phd

  Queen's University and Kingston Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Helen S. Driver, Assistant Professor, Division of Respirology and Sleep Medicine, Dept. Medicine, Queen's University

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 31, 2021
• Study Start: February 7, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)