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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05290792
Recruitment Status : Active, not recruiting
First Posted : March 22, 2022
Last Update Posted : August 2, 2022
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Université de Montréal
Information provided by (Responsible Party):
Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Viral Respiratory Tract Infection Influenza Biological: Administration of FluMist (Live Attenuated Influenza Vaccine) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single centre, controlled, before and after, longitudinal, intra-individual assessment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections: The WE SENSE Study
Actual Study Start Date : December 10, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT05290792


Locations
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Canada, Quebec
Centre for Innovative Medicine - McGill University Health Centre
Montréal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
Emily McDonald
Canadian Institutes of Health Research (CIHR)
Université de Montréal
Investigators
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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
More Information
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Publications:

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Responsible Party: Emily McDonald, Associate Professor of Medicine, MD MSc FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT05290792    
Other Study ID Numbers: 2022-7591
First Posted: March 22, 2022    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022

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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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Infections
Communicable Diseases
Respiratory Tract Infections
 Disease Attributes
Pathologic Processes
Respiratory Tract Diseases