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Trial registered on ANZCTR


Registration number
ACTRN12625000249459
Ethics application status
Approved
Date submitted
30/01/2025
Date registered
4/04/2025
Date last updated
4/04/2025
Date data sharing statement initially provided
4/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Driver Sleepiness Detection Device – Optimising Road Safety by Targeting Sleepiness on Australian Roads
Scientific title
Validation of vestibular and ocular motor function screening assessment to predict trait and state driver sleepiness and driving impairment in adults during periods of extended wakefulness
Secondary ID [1] 313765 0
Lifetime Support Authority R24009
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study of the registration record ACTRN12621001610820.

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnoea 336377 0
Condition category
Condition code
Respiratory 332902 332902 0 0
Sleep apnoea
Neurological 333105 333105 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants/Screening
Participants (all genders; 18-75yrs; hold a current provisional or full driver’s license) will be 1) health sleepers (Good Sleeper Scale score >=45); people with obstructive sleep apnoea (formal diagnosis history, or OSA score >=5); and shift workers (current self-reported night-time shift workers). Potential participants will complete the EOI Screening and Demographic Survey to register their interest in the study and complete the following measures:

- Epworth Sleepiness Scale (ESS) - measure of daytime sleepiness
- Good Sleeper Scale - measure of sleep behaviours
- OSA50 - measure of obstructive sleep apnoea symptoms

Consent Meeting/practice testing
Eligible participants will attend an in-person consent session at FHMRI Sleep Health at a mutually beneficial time. During this screening visit, potential participants will practice all aspects of the testing, which will allow them to understand exactly what will be expected, as well as screen out those who become nauseous during any of the tests.
- Oktal Sydec driving simulator (10 minutes during screening, and 30 minutes during in-laboratory protocol)
- AusEd driving simulator (30 minute practice during screening, and 60 minutes during in-laboratory protocol)
- NeuroFlex VOMS Device using VR goggles involving a. Eye tracking with head movement (30 seconds); b. Eye-only tracking (30 seconds); c. Horizontal and horizontal vestibular ocular reflex (30 seconds); d. Saccades (60 seconds); e. Antisaccades (60 seconds); f. Optokinetic nystagmus (45 seconds); g. Spontaneous nystagmus (45 seconds).
- Karolinska Drowsiness Test (KDT) – measures sleepiness through EEG. The KDT allows for objective measures of sleepiness within each participant. (10 minutes)
- Karolinska Sleepiness Scale (KSS) – a 1-9 Likert scale that measures a person’s subjective levels of sleep (30 seconds)
- Psychomotor Vigilance Test (PVT) - measures single-stimulus reaction time (10 minutes)
- NASA Task Load Index (NASA-TLX) – measures perceived demand, performance, effort, and frustration (1 minute)
- Attentional network task (ANT) – measures choice reaction time to stimuli with occasional leading stimuli that indicate where the stimuli will appear next (15 minutes)If the participant agrees to undertake the protocol, they will be booked to come back into the FHMRI Sleep Health Group approximately 2-weeks after the screening visit.

Pre-laboratory Protocol
Participants will undergo 2 weeks of monitoring at home using actigraphy (GENEActiv - non-GPS), under-mattress sleep sensor (Withings - non-GPS), and a sleep diary to track their sleep/wake activity. The 1st week will be their habitual sleep/wake patterns and the 2nd week will be an enforced sleep/wake routine based on their habitual data and preference to minimise any impact of sleep loss or circadian influences leading up to the extended wakefulness protocol.

In-laboratory Protocol
Participants will spend approximately 40 hours at the Adelaide Institute for Sleep Health laboratory (attached as Protocol Schematic). Participants will arrive at the lab by taxi (paid for by the research study). Participants will swallow an e-Celcius BodyCap which sends internal temperature measurements to an external monitor. Generally, these capsules only take 24-hours to be passed with normal bowel movements so it is expected that participants may need to swallow two throughout their laboratory stay. Participants will complete the sleep and health survey via RedCap. This survey takes approximately 30-45 minutes to complete.

- Alertness Strategies - measure of behaviours to improve alertness while driving
- Covert and Overt Reassurance Seeking Inventory (CORSI) - measure of reassurance-seeking behavior
- Decisions to Drive Questionnaire - reasons for driving
- Depression Anxiety and Stress Scale 21 (DASS-21) - measure of depression, anxiety, and stress symptoms
- Driving Questions - driving behaviours
- Dysfunctional Beliefs and Attitudes about Sleep (DBAS) - beliefs and attitudes about sleep
- ESQ -measure of sleepiness and fatigue
- Evening Questionnaire - measure of the previous night's sleep and daytime behaviour
- Flinders Fatigue Scale - measure of fatigue severity
- Functional Outcomes of Sleep Questionnaire (FOSQ-10) - measure of the functional impact of sleepiness
- Health And Work Performance Questionnaire (HPQ) - measure of workplace costs of health problems
- Insomnia Severity Index (ISI) - measure of insomnia symptoms
- Morningness-Eveningness Composite Questionnaire - measure of chronotype
- Motor Vehicle Accidents - motor vehicle accident history
- Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - measure of the impact of sleep
- Pittsburgh Sleep Quality Index (PSQI) - measure of sleep quality
- Restless Legs Syndrome RLSSQ - measure of restless leg syndrome symptoms
- Short Form Health Survey (SF-20) - measure of health-related quality of life
- Sleep Need Questionnaire - measure of sleep needs
- Workplace Accidents - workplace accident history

Participants will complete the Oktal driving simulator. On the initial night, participants will undergo an overnight Polysomnography (PSG) session, offering a 9-hour baseline sleep opportunity. Audio and visual PSG recordings will be used during the stay in the lab for sleep measurement and during performance testing to score sleep/identify and ensure participant safety. Data quality and set-up procedures for the PSG will be recorded in the Overnight Check Sheet. After waking, participants will complete the Morning Questionnaire and Sleep Diary. Approximately an hour after their predetermined wake time, they will commence the first simulated driving and performance task testing phase, lasting a total of 2 hours (pre-drive VOMS, AusEd, post-drive VOMS, NASA-TLX, KSS, KDT, KSS, PVT, NASA-TLX, ANT, NASA-TLX). After a designated 'free time' interval, participants will engage in a second testing phase (a similar testing phase, without the simulated drive: VOMS, NASA-TLX, KSS, KDT, KSS, PVT, NASA-TLX, ANT, NASA-TLX). Participants will be given a minimum of a 1-hour break before repeating the VOMS assessment. These batteries will be repeated five times over the course of the 29-hour extended wakefulness protocol, at 6 hours apart. Once complete, participants will complete the Oktal driving simulator again. Meal opportunities will be scheduled periodically throughout the in-lab protocol. Participants will have the PSG equipment removed, will sign a driving disclaimer, and will be sent home from the laboratory via a taxi (paid for by the research study) to eliminate driving risk. Participants will be offered an opportunity to have a recovery sleep in the laboratory before being sent home via a paid taxi.
Intervention code [1] 330349 0
Behaviour
Comparator / control treatment
No control group will be used. Comparisons are not planned to be made between cohorts.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340429 0
Independent sensitivity of the NeuroFlex® vestibular and ocular motor (VOM) device to detect trait driver sleepiness and driving impairment across extended wakefulness periods
Timepoint [1] 340429 0
AusEd simulator (1, 7, 13, 19, 25 hours into extended wakefulness protocol) VOMS assessment immediately pre- and post-AusEd simulator
Primary outcome [2] 340641 0
Independent sensitivity of the NeuroFlex® vestibular and ocular motor (VOM) device to detect state driver sleepiness and driving impairment across extended wakefulness periods
Timepoint [2] 340641 0
AusEd simulator (1, 7, 13, 19, 25 hours into extended wakefulness protocol) VOMS assessment immediately pre- and post-AusEd simulator
Secondary outcome [1] 444031 0
Comparison of the NeuroFlex® vestibular and ocular motor (VOM) device to Psychomotor Vigilance Test (PVT) at detecting driving impairment on the AusEd driving simulator
Timepoint [1] 444031 0
AusEd simulator (1, 7, 13, 19, 25 hours into extended wakefulness protocol) VOMS assessment immediately pre- and post-AusEd simulator PVT 20 minutes following the AusEd simulator
Secondary outcome [2] 444686 0
Comparison of the NeuroFlex® vestibular and ocular motor (VOM) device to the Karolinska Drowsiness Test (KDT) at detecting driving impairment on the AusEd driving simulator
Timepoint [2] 444686 0
AusEd simulator (1, 7, 13, 19, 25 hours into extended wakefulness protocol) VOMS assessment immediately pre- and post-AusEd simulator KDT 10 minutes following the AusEd simulator
Secondary outcome [3] 444687 0
Comparison of the NeuroFlex® vestibular and ocular motor (VOM) device to the Attention Network Test (ANT) at detecting driving impairment on the AusEd driving simulator
Timepoint [3] 444687 0
AusEd simulator (1, 7, 13, 19, 25 hours into extended wakefulness protocol) VOMS assessment immediately pre- and post-AusEd simulator ANT 30 minutes following the AusEd simulator
Secondary outcome [4] 444689 0
Comparison of the NeuroFlex® vestibular and ocular motor (VOM) device to the Karolinska Sleepiness Scale (KSS) at detecting driving impairment on the AusEd driving simulator
Timepoint [4] 444689 0
AusEd simulator (1, 7, 13, 19, 25 hours into extended wakefulness protocol) VOMS assessment immediately pre- and post-AusEd simulator KSS immediately pre-AusEd simulator
Secondary outcome [5] 445349 0
Core body temperature as a predictor of Vestibular and ocular motor (VOM) performance and AusEd driving simulator performance
Timepoint [5] 445349 0
AusEd simulator (1, 7, 13, 19, 25 hours into extended wakefulness protocol) VOMS assessment immediately pre- and post-AusEd simulator Core Body temperature throughout the in-lab study
Secondary outcome [6] 445354 0
Comparison of the NeuroFlex® vestibular and ocular motor (VOM) device to the NASA Task Load Index (NASA-TLX) at detecting driving impairment on the AusEd driving simulator
Timepoint [6] 445354 0
AusEd simulator (1, 7, 13, 19, 25 hours into extended wakefulness protocol) VOMS assessment immediately pre- and post-AusEd simulator NASA Task Load Index (NASA-TLX) immediately following Attention Network Test (ANT) and Psychomotor Vigilance Test (PVT)

Eligibility
Key inclusion criteria
All genders; 18-75yrs; current provisional or full driver’s license; healthy sleepers or people with obstructive sleep apnea or nighttime shift workers.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of medications that alter sleep; uncontrolled psychiatric illness; other severe or unstable medical conditions; history of traumatic brain injury, stroke, or neurodegenerative disorder (e.g. Parkinson’s disease, dementia); epilepsy or photosensitivity conditions.
Participants screened as being sensitive to motion sickenss due to the driving simulation testing.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data analysis involves a two-stages. First, ensemble of machine learning (ML) will be trained on VOMS metrics generated by the NeuroFlex® software to rank the top 10 metrics most predictive of driving outcomes. Using ensemble models yields highly reliable predictions with reduced uncertainty compared to a single ML model. Second, an in-depth analysis of the top 10 prediction metrics will be conducted by exploring their raw time-series data. Extensive automated time-series feature extraction will be performed to derive approximately 8,000 interpretable features. Combining these massive features with the top 10 VOMS metrics, a new ML model will be trained to further optimise the performance of the initial ML models. This fully data-driven model aims to enhance the ensemble model and explore new features of VOMS that may better predict sleepiness related driving impairment. This novel two-stage analytic approach leverages both the interpretability of time-series features and the predictive power of machine learning models, resulting in a fully transparent and highly accurate predictive model. Receiver Operator Characteristic curve analysis will be undertaken to evaluate the sensitivity and specificity of NeuroFlex VOMS assessment for identifying poor driving performance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2027
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318226 0
Government body
Name [1] 318226 0
Lifetime Support Authority
Country [1] 318226 0
Australia
Primary sponsor type
University
Name
FHMRI Sleep Health - Flinders University
Address
Country
Australia
Secondary sponsor category [1] 320612 0
None
Name [1] 320612 0
Address [1] 320612 0
Country [1] 320612 0
Other collaborator category [1] 283373 0
Commercial sector/Industry
Name [1] 283373 0
NeuroFlex
Address [1] 283373 0
Country [1] 283373 0
Australia
Other collaborator category [2] 283374 0
University
Name [2] 283374 0
Institute for Breathing and Sleep - University of Melbourne
Address [2] 283374 0
Country [2] 283374 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316869 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 316869 0
Ethics committee country [1] 316869 0
Australia
Date submitted for ethics approval [1] 316869 0
17/01/2025
Approval date [1] 316869 0
07/02/2025
Ethics approval number [1] 316869 0
8131

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

Contacts
Principal investigator
Name 139262 0
A/Prof Andrew Vakulin
Address 139262 0
Flinders University, FHMRI Sleep Health, Mark Oliphant Building, 5 Laffer Drive, Bedford Park, South Australia 5042
Country 139262 0
Australia
Phone 139262 0
+61 08 7221 8308
Fax 139262 0
Email 139262 0
[email protected]
Contact person for public queries
Name 139263 0
Andrew Vakulin
Address 139263 0
Flinders University, FHMRI Sleep Health, Mark Oliphant Building, 5 Laffer Drive, Bedford Park, South Australia 5042
Country 139263 0
Australia
Phone 139263 0
+61 08 7221 8308
Fax 139263 0
Email 139263 0
[email protected]
Contact person for scientific queries
Name 139264 0
Andrew Vakulin
Address 139264 0
Flinders University, FHMRI Sleep Health, Mark Oliphant Building, 5 Laffer Drive, Bedford Park, South Australia 5042
Country 139264 0
Australia
Phone 139264 0
+61 08 7221 8308
Fax 139264 0
Email 139264 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual de-identified data of published results only

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Data sharing request system: Flinders University ROADS (Repository of Open Access Datasets) by emailing principal research ([email protected])

Are there extra considerations when requesting access to 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.