se 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.

Not Applicable

Recruiting

Conditions: Infectious disease
Vaccination
Infection - Other infectious diseases
Public Health - Other public health
Cardiovascular - Normal development and function of the cardiovascular system
Inflammatory and Immune System - Normal development and function of the immune system

Registration Number: ACTRN12624000208505

Lead Sponsor: niversity of South Australia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

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.

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

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate [Using data from the Empatica Embraceplus and Garmin Venu SQ2 devices 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,];Respiration rate[Using data from the Empatica Embraceplus and Garmin Venu SQ2 devices 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.];Temperature[Using data from the Empatica Embraceplus device. 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 Measures

Name	Time	Method
Sleep metrics: Total sleep time, time in light, deep, and REM sleep will be assessed as a composite secondary outcome[Sleep metrics collected by the Empatica Embraceplus, Garmin Venu SQ2 and MotionWatch 8 wearable devices Baseline sleep metrics as established by sleep data collected 11-days prior to vaccination and changes in sleep metrics for 3-days post vaccination.]