Trial Review

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:30pm (AEST) on Thursday 31st July for website maintenance.

Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000749404
Ethics application status
Approved
Date submitted
30/06/2025
Date registered
15/07/2025
Date last updated
15/07/2025
Date data sharing statement initially provided
15/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Wearable Technology and Fatigue study
Scientific title
Evaluating the Accuracy of Fine-Tuned Biometric Models using Wearable Technology in Healthy Adults undergoing a Sleep Deprivation Protocol in hot versus cold environments
Secondary ID [1] 314779 0
N00014-24-S-B001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Performance 338010 0
Metabolic Health 338011 0
Physiological Health 338018 0
Condition category
Condition code
Mental Health 334324 334324 0 0
Studies of normal psychology, cognitive function and behaviour
Metabolic and Endocrine 334329 334329 0 0
Normal metabolism and endocrine development and function
Cardiovascular 334330 334330 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 4-day in-laboratory sleep deprivation protocol. All participants will enter the laboratory at 10:00 on Day 1, and complete training on the cognitive tasks before being given a baseline night sleep of 8 hours before being woken at 7 am on Day 2. All participants will then be kept awake for 40hours, before being given a night-time recovery sleep of 8 hours.

To assess the impact of environment temperature on Military training personnel. one group of participants will experience warmer temperatures (~30C) in the lab while another group will experience cooler temperatures (~18C).

Participants will live in the environmentally controlled Simulation Laboratory (part of the Behaviour-Brain-Body Research Centre at University of South Australia) laboratory for multiple days. To ensure adherence to the protocol participants will be supervised by two research assistants at any given time.

During the sleep deprivation period, participants will complete a number of performance-based assessment tasks including simulated driving and neural behavioural test batteries. During this time, a number of wearable devices will also be fitted to the participants to collect physiological data on heart rate, activity, respiration rate, continuous glucose and temperature.

Devices being used in the study will be the Empatica Embraceplus, Samsung Galaxy watch, and MotionWatch8 which will be worn on participants wrists, Participants will also be fitted with a CORE temperature reader which is worn on the torso, and the FreeStyle Libre 2 . Participants will be wearing the devices at all times except for showering during which the devices will be charging. Device analytics for Empatica, FreeStyle Libre 2 and Samsung devices will provide researchers with relative real time information. Device analytics for MotionWatch8 and CORE temperature will only be obtained once participants have finished testing and researchers download the data.

This is a randomised control trial, participants will be allocated to either warm or cooler temperature at the group level (run) using an online software tool.
Intervention code [1] 331382 0
Lifestyle
Comparator / control treatment
Cooler temperature will be used as an active control
Control group
Active

Outcomes
Primary outcome [1] 341989 0
Establish ground truth data set Heart Rate
Timepoint [1] 341989 0
Continuous across sleep deprivation protocol
Primary outcome [2] 341990 0
Establish ground truth data set Respiration Rate
Timepoint [2] 341990 0
Continuous throughout Sleep Deprivation
Primary outcome [3] 341991 0
Establish ground truth data set Sleep metrics: Total sleep time, time in light, deep, and REM sleep to be assessed as a composite outcome
Timepoint [3] 341991 0
Baseline and Recovery Sleep
Secondary outcome [1] 449253 0
Temperature
Timepoint [1] 449253 0
Continuous throughout Sleep Deprivation
Secondary outcome [2] 449254 0
Interstitial Glucose
Timepoint [2] 449254 0
Continuous throughout Sleep Deprivation protocol
Secondary outcome [3] 449255 0
Cognitive functioning
Timepoint [3] 449255 0
Every 3-hours during sleep deprivation protocol
Secondary outcome [4] 449505 0
Cognitive functioning
Timepoint [4] 449505 0
Every 3-hours during sleep deprivation protocol
Secondary outcome [5] 449506 0
Teaming
Timepoint [5] 449506 0
Every 3-hours during sleep deprivation protocol
Secondary outcome [6] 449507 0
Cognitive functioning
Timepoint [6] 449507 0
Every 3-hours during sleep deprivation protocol
Secondary outcome [7] 449508 0
Cognitive functioning
Timepoint [7] 449508 0
Every 3-hours during sleep deprivation protocol

Eligibility
Key inclusion criteria
Participants must be aged 18- 40y, have normal sleep/wake behaviour and meet the Australian physical activity and exercise guidelines (2.5 to 5 hours of moderate intensity physical activity, OR 1.25 to 2.5 hours of vigorous intensity physical activity, OR an equivalent combination of moderate and vigorous activities) to be comparable to the demographics and fitness levels to military personnel
Minimum age
18 Years
Maximum age
40 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.
Interstate or overseas travel in the prior 30 days
Habitual nightly sleep amounts 1 time a week
Caffeine use > 400 mg (e.g. 8 caffeinated sodas or approximately 3 to 4 cups of coffee) per day,
History of cardiovascular disease
History of neurologic disorder
Underlying pulmonary disease requiring daily inhaler use
Kidney disease or abnormalities, liver disease or abnormalities,
History of psychiatric disorder requiring hospitalization or psychiatric product for any length of time.
Active-duty military, emergency service, first responders,
Significant depression (>14 on the Beck's Depression Inventory),
Significant traumatic event or mental health issues (self-reported or suspected) that may be triggered by sleep deprivation and/or recovery sleep.
Regular nicotine use (> 1 cigarette or equivalent per week) within the last year,
Self-reported or suspected heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week
Self-reported or suspected current use of other illicit drugs (including but not limited to benzodiazepines, amphetamines, cocaine, marijuana), currently taking corticosteroid or anti-­inflammatory medications.
Inability to satisfactorily complete cognitive tasks at training

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer using the online research randomizer tool (https://www.randomizer.org/)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software tool online at run level (run = 4 participants are enrolled at one time and will all undergo the same condition).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2025
Actual
Date of last participant enrolment
Anticipated
17/01/2027
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 44365 0
5072 - Magill

Funding & Sponsors
Funding source category [1] 319334 0
Government body
Name [1] 319334 0
Office of Naval Research
Country [1] 319334 0
United States of America
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 321822 0
None
Name [1] 321822 0
Address [1] 321822 0
Country [1] 321822 0
Other collaborator category [1] 283581 0
Commercial sector/Industry
Name [1] 283581 0
FortifyEdge
Address [1] 283581 0
Country [1] 283581 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317916 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 317916 0
Ethics committee country [1] 317916 0
Australia
Date submitted for ethics approval [1] 317916 0
21/05/2024
Approval date [1] 317916 0
16/07/2024
Ethics approval number [1] 317916 0
206347

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

Contacts
Principal investigator
Name 142542 0
Prof Siobhan Banks
Address 142542 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072
Country 142542 0
Australia
Phone 142542 0
+61 08 83021712
Fax 142542 0
Email 142542 0
[email protected]
Contact person for public queries
Name 142543 0
Siobhan Banks
Address 142543 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072
Country 142543 0
Australia
Phone 142543 0
+61 08 83021712
Fax 142543 0
Email 142543 0
[email protected]
Contact person for scientific queries
Name 142544 0
Siobhan Banks
Address 142544 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072
Country 142544 0
Australia
Phone 142544 0
+61 08 83021712
Fax 142544 0
Email 142544 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No



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.