Clinical trial NCT05290792: Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections
Official title: Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections: The WE SENSE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Respiratory Tract Infection
Influenza
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Université de Montréal
First posted: 2022-03-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single centre, controlled, before and after, longitudinal, intra-individual assessment
Primary purpose: SCREENING

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.

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.

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.

Primary outcomes:
measure: Changes in heart rate (in beats per minute)
timeFrame: 14 days
measure: Changes in heart rate variability (in milliseconds)
timeFrame: 14 days
measure: Changes in respiratory rate (in breaths per minute)
timeFrame: 14 days
measure: Changes in skin temperature (in degrees Celsius)
timeFrame: 14 days
measure: Changes in acceleration (meters/second^2)
timeFrame: 14 days
measure: Changes in blood pressure (in mmHg)
timeFrame: 14 days
measure: Changes in oxygen saturation (SpO2 in %)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre for Innovative Medicine - McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Emily G McDonald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Dennis Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
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