Skip to content

Driver Sleepiness Detection Device – Optimising Road Safety by Targeting Sleepiness on Australian Roads

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000249459
Enrollment
60
Registered
2025-04-04
Start date
2025-05-01
Completion date
2027-09-01
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

A laboratory-based study will recruit adults 18-75 years (healthy sleepers, shift workers, and individuals with sleep apnoea). Participants will be exposed to a 29-hour extended wakefulness protocol as part of the intervention. During this time, participants will complete cognitive testing, vestibular and ocular motor (VOM) assessments, and driving simulators. The study will determine whether changes in VOM reflexes, measured objectively by the NeuroFlex device, can identify those who are sleepy and at risk of a motor vehicle accident during an extended wakefulness protocol.

Interventions

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

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.

Sponsors

FHMRI Sleep Health - Flinders University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026