Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000208505
Ethics application status
Approved
Date submitted
1/02/2024
Date registered
1/03/2024
Date last updated
23/06/2024
Date data sharing statement initially provided
1/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of consumer smart wearable devices to detect early changes in physiological measures (heart rate, respirations and temperature) following vaccination before symptomatic onset of response to vaccine.
Scientific title
Consumer wearable devices and real-time detection of changes in physiological measures (heart rate, respirations and temperature) prior to onset of symptomatic reaction, post vaccination.
Secondary ID [1] 311452 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infectious disease 332749 0
Vaccination
 332908 0
Condition category
Condition code
Infection 329469 329469 0 0
Other infectious diseases
Public Health 329470 329470 0 0
Other public health
Cardiovascular 329623 329623 0 0
Normal development and function of the cardiovascular system
Inflammatory and Immune System 329624 329624 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To accurately establish baseline physiological data for heart rate, respiration rate, and temperature, and to correctly detect changes in these physiological measures post vaccination, participants will be required to wear devices for 10 consecutive days prior to receiving their vaccination on day-11 and then for 3 consecutive days post vaccination.
Participants will be required to book and receive a vaccination of their choosing e.g., seasonal flu, travel-based or COVID-19 booster shot on day-11 of the study and then continue wearing the device for an additional 3-days. Devices being used in the study will be the Empatica Embraceplus, Garmin Venu SQ2 and the MotionWatch8. All are wrist worn devices and as such will be worn on participants wrists. Participants will be advised to wear devices at all times except for swimming, showering and charging. Device analytics for Empatica and Garmin devices will provide researchers with relative real time information to monitor adherence to the device wearing protocol.. Device analytics for MotionWatch8 will only be obtained once participants have returned the device and researchers download the data.
Intervention code [1] 327899 0
Early Detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337281 0
Heart rate
Timepoint [1] 337281 0
Baseline heart rate as established from heart rate data collected by the Empatica Embraceplus and Garmin Venu SQ2 devices 11-days prior to receipt of vaccination and then changes in heart rate post vaccination for 3-days,
Primary outcome [2] 337412 0
Respiration rate
Timepoint [2] 337412 0
Baseline respiration rate as established from respiration data collected 11-days prior to receipt of vaccination and then changes in respiration rate post vaccination for 3-days.
Primary outcome [3] 337413 0
Temperature
Timepoint [3] 337413 0
Baseline temperature as established from temperature data collected 11-days prior to vaccination and then changes in temperature post vaccination for 3-days.
Secondary outcome [1] 431311 0
Sleep metrics: Total sleep time, time in light, deep, and REM sleep will be assessed as a composite secondary outcome
Timepoint [1] 431311 0
Baseline sleep metrics as established by sleep data collected 11-days prior to vaccination and changes in sleep metrics for 3-days post vaccination.

Eligibility
Key inclusion criteria
Participants must be between 18-years to 65-years of age
Have booked to receive, no less than 10-days prior to collection of devices, an annual flu vaccination or COVID19 booster or travel vaccine.
The vaccination must be administered by a registered health practitioner to participate in the study.
Participants must have a normal body temperature between 36-37 degrees Celsius on the day the wearable devices are collected.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Wrist or forearm tattoos located in the area where the wearable devices will be worn.
Had no interstate or overseas travel in the prior 30 days
Had symptoms of an acute respiratory infection in the prior 14 days:
o cough
o sore throat
o fever or chills
o runny nose
o shortness of breath
o loss of taste and smell.
Contact in the last month with a person that had symptoms of an acute respiratory infection (including someone who has COVID19).
Contact in the last 14-days with a suspected or confirmed COVID19 case
Will not recruit
o people 65 years and older with chronic medical conditions
o people 70 years and older
o people with chronic conditions or compromised immune systems
o people in aged care facilities
o people with a disability

Study design
Purpose
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
8/04/2024
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
14/04/2025
Actual
Sample size
Target
100
Accrual to date
51
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315732 0
Government body
Name [1] 315732 0
Department of Defence
Country [1] 315732 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 317846 0
None
Name [1] 317846 0
Address [1] 317846 0
Country [1] 317846 0
Other collaborator category [1] 282939 0
Commercial sector/Industry
Name [1] 282939 0
Insight Via Artificial Intelligence (IVIA)
Address [1] 282939 0
Country [1] 282939 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314595 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 314595 0
Ethics committee country [1] 314595 0
Australia
Date submitted for ethics approval [1] 314595 0
17/02/2023
Approval date [1] 314595 0
22/02/2023
Ethics approval number [1] 314595 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132126 0
Prof Siobhan Banks
Address 132126 0
University of South Australia, St Bernards Road Magill, SA 5072
Country 132126 0
Australia
Phone 132126 0
+61883021712
Fax 132126 0
Email 132126 0
siobhan.banks@unisa.edu.au
Contact person for public queries
Name 132127 0
Siobhan Banks
Address 132127 0
University of South Australia, St Bernards Road Magill, SA 5072
Country 132127 0
Australia
Phone 132127 0
+61883021712
Fax 132127 0
Email 132127 0
siobhan.banks@unisa.edu.au
Contact person for scientific queries
Name 132128 0
Siobhan Banks
Address 132128 0
University of South Australia, St Bernards Road Magill, SA 5072
Country 132128 0
Australia
Phone 132128 0
+61883021712
Fax 132128 0
Email 132128 0
siobhan.banks@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.