Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections (WE SENSE)

October 31, 2023 updated by: Emily McDonald

Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections: The WE SENSE Study

Viral respiratory tract infections (VRTI) are among the most common human illnesses, impacting billions globally. There is an unmet need to identify novel ways to detect, treat and prevent their spread. New wearable devices could address this need, using special biosensors worn by patients.

This is a single centre, controlled, before and after, longitudinal, clinical trial. Participants will receive FluMist, a live attenuated influenza vaccine, which will act as a proxy to a viral respiratory tract infection and create a very minor response to the immune system. Vital signs and activity levels will be monitored continuously using wearable biosensors for 7 days prior to and 7 days following, along with symptom tracking and blood tests to measure immune responses. Artificial intelligence (AI) and machine learning (ML) algorithms will be used to analyse the data.

AI and ML will identify subtle changes in vital signs and activity levels from the immune response to respiratory viruses. These data will help develop future methods to address important public health questions related to respiratory virus detection, containment and management.

The purpose of this study is to explore whether wearable sensors can detect, track the progress and recovery from viral respiratory tract infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Presently, there are no tools to continuously assess the objective body's response to respiratory viral infection in real time. An individual's inflammatory response to infection is primarily measured by the presence of symptoms. For example, reliance on the presence of fever as a sensitive sign of viral infection, while objective and measurable, can miss at least 50% of symptomatic cases of influenza illness. Fever is also not a sufficient sign of infection in studies of SARS-CoV-2. An additional technology to pair with the present contact tracing, test and contain strategy could become a critical public health mitigation strategy for VRTIs. Evidence suggests that use of wearable biosensor technology may enable researchers and healthcare professionals to detect inflammatory responses. Therefore, they could assist in medical diagnosis at the early phase of disease development - even before the onset of clinical symptoms.

In this study, the investigators aim to leverage FLUMIST, an intranasal Live Attenuated Influenza Vaccine (LAIV), to create a very minor response of the immune system. FLUMIST is one of the vaccines recommended by the National Advisory Committee on Immunization (NACI), among other vaccines for this flu season. It will be used as a test case, representing body's response to a minor viral infection (like those of 'common cold'). In addition, the associated changes in vital signs (for example, changes in heart rate), activity levels, symptoms and inflammatory/immune markers will be monitored. Subtle patterns of change might only be detectable using artificial intelligence (AI). Applying AI and machine learning (ML) to the wearables' data can allow for the future early detection of VRTI, along with continuous tracking of its progress, recovery or deterioration.

Study schedule:

Patient participation in this research project will last 2 weeks and will include 14 visits. Each visit will last up to 60 minutes. During this 14-day follow-up period, participants will be required to wear 3 vital signs monitoring systems (shirt, watch and a ring) and to report twice daily about their wellbeing/symptoms and about their alcohol/caffeine/drugs consumption.

Assessments:

-VRTI detection: To rule out asymptomatic VRTI during the baseline (pre-LAIV) period, a nasopharyngeal 21-multiplex polymerase chain reaction (PCR) test, which includes influenza, SARS-CoV-2 and other respiratory viruses, will be performed at screening. For those eligible participants that enter the study, baseline assessments will start the morning of Day -7 and be performed 7 days before inoculation (Days -7 to 0), which will occur the morning of Day 0.

-Symptom assessment: The following symptoms will be assessed through an app-based survey sent to participants twice daily during the 14-day observation period: nasal discharge; nasal obstruction; sneezing; headache; sore throat; malaise; muscle ache; cough; chilliness; decreased appetite; stomach ache; vomiting; diarrhea; shortness of breath; and wheeze. Symptom severity will be graded as 0 (absent) to 7 (severe).

-Wearable vital sign monitoring systems: Three wearable smart platforms will be used for continuous monitoring of physiologic and activity parameters using biosensors: Oura ring (Oura Oy, Finland); Biobeat watch (Biobeat technologies LTD, Israel); and Astroskin shirt (by Hexoskin, Canada).

-Inflammatory cytokines and biomarkers: A venous blood sample for measurement of inflammatory cytokines and biomarkers will be obtained by a healthcare professional once in the morning of Day -7 (baseline sample 1) and then twice daily starting Day 0, with baseline sample #2 collected prior to inoculation on Day 0.

-Physiological response assessment: Participants will complete five, 3-minute constant-rate stair stepping tests (3-min CRSST). The 3-min CRSST requires participants to step up and down a 20cm step to the pace of a constant external audio beep. Participants will complete all trials at a 30 steps/min stepping rate. Cardiac and respiratory parameters will be collected at rest and during each 3-min CRSST using the wearable devices.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Centre for Innovative Medicine - McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men or women aged 18-59 years
  • Did not receive the 2021-2022 seasonal influenza vaccine
  • Not planning to get another vaccine during the 14-day observation period.

Exclusion Criteria:

  • PCR-confirmed VRTI at screening
  • Any infectious symptoms (fever, cough, rhinorrhea, sore throat, diarrhea, loss of smell or taste) within the previous 7 days
  • Any chronic medical condition;
  • Obesity (BMI>35 kg/m2);
  • Any prescription drug other than oral contraceptives or routine and stable dose medications;
  • Contraindication to LAIV
  • Current smoker or ex-smoker with >20 pack years of smoking
  • Recreational drug use
  • Self-reported history of substance abuse
  • Pregnant or attempting to become pregnant
  • Guillain-Barré syndrome (GBS) or BGS-like episode has occurred within 6 weeks of any prior influenza vaccination
  • Immunocompromised
  • People with severe asthma or medically attended wheezing in the 7 days prior to the proposed date of vaccination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intra-individual changes of physiological and activity parameters

Participants will be administered FluMist (live attenuated influenza vaccine) to induce a low grade VRTI (Day 0). Participants will be monitored in the 7 days prior and 7 days after vaccination via symptom questionnaires, blood draws, stair tests and vital sign monitoring from wearable sensors.

Each participant will serve as their own control, relying on the baseline measurements obtained over the 7-day period prior to inoculation.
Biological: Administration of FluMist (Live Attenuated Influenza Vaccine)
Participants will received the intranasal FluMist vaccine that will serve as a proxy for a viral respiratory tract infection and trigger a mild immune response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in heart rate (in beats per minute)
Time Frame: 14 days
Intra-individual changes in heart rate before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
14 days
Changes in heart rate variability (in milliseconds)
Time Frame: 14 days
Intra-individual changes in heart rate variability before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
14 days
Changes in respiratory rate (in breaths per minute)
Time Frame: 14 days
Intra-individual changes in respiratory rate before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
14 days
Changes in skin temperature (in degrees Celsius)
Time Frame: 14 days
Intra-individual changes in skin temperature before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
14 days
Changes in acceleration (meters/second^2)
Time Frame: 14 days
Intra-individual changes in acceleration before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
14 days
Changes in blood pressure (in mmHg)
Time Frame: 14 days
Intra-individual changes in blood pressure before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
14 days
Changes in oxygen saturation (SpO2 in %)
Time Frame: 14 days
Intra-individual changes in oxygen saturation before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emily McDonald

Collaborators

Canadian Institutes of Health Research (CIHR)
Université de Montréal

Investigators

  • Principal Investigator: Emily G McDonald, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Dennis Jensen, PhD, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-7591

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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