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Wearable Technology and Fatigue study

Evaluating the Accuracy of Fine-Tuned Biometric Models using Wearable Technology in Healthy Adults undergoing a Sleep Deprivation Protocol in hot versus cold environments

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000749404
Enrollment
52
Registered
2025-07-15
Start date
2025-07-30
Completion date
2027-01-17
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sophisticated wearable sensors now exist that can collect an almost continuous stream of physiological data. These sensors have evolved from simple fitness tracking devices to multifunctional, compact, and versatile sensors, which can be integrated into clothing or attached to the body to monitor our physiology & interact and communicate. While the sensors have rapidly evolved & become highly sophisticated in recent years, there remains many issues with the algorithms used to analyse the sensor data. They are imprecise, often inaccurate & frequently misinterpret data, incorrectly labelling movements as ‘steps’ or reading a book as ‘sleep’. This incongruity creates a reluctance to use & rely on these wearable sensors, even though their potential to provide increased awareness about physiological and mental state is tremendous. The standard software also frequently relies on averaged and aggregated data for any predictions about state, rather than tailored to the individual. If wearables are to be used in a variety of complex, austere environments (those where access to resources is significantly limited or unavailable) personnel must be able to trust not only the sensors to measure signals accurately but also the algorithms & software to analyse & interpret the data correctly. There is a need for more accurate, sophisticated algorithms to take advantage of the next generation sensors on the market and a more personalised, individual approach is needed to build trust and increase acceptance. Using deep expertise in understanding individual performance dynamics over time, under different environments and conditions to refine novel algorithms.

Interventions

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 t

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.

Sponsors

University of South Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026