Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections: The WE SENSE Study
Trial ID: NCT05290792
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-12-10
Completion date: 2022-10-31
Sponsor: Emily McDonald
Collaborators: Canadian Institutes of Health Research (CIHR); Université de Montréal
Conditions: Viral Respiratory Tract Infection; Influenza
Interventions: Administration of FluMist (Live Attenuated Influenza Vaccine)
Locations: Centre for Innovative Medicine - McGill University Health Centre
Countries: Canada
Enrollment: 56
Age range: 18 Years - 59 Years
Sex: ALL

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.

Eligibility 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.

Outcomes:
Changes in heart rate (in beats per minute); Changes in heart rate variability (in milliseconds); Changes in respiratory rate (in breaths per minute); Changes in skin temperature (in degrees Celsius); Changes in acceleration (meters/second^2); Changes in blood pressure (in mmHg); Changes in oxygen saturation (SpO2 in %)