RecruitingACTRN12621001610820

Determining the effectiveness of vestibular (balance) and ocular (eye movement) motor function screening assessments for identifying sleepy drivers.

Determining the effectiveness of vestibular and ocular motor function screening assessments for identifying sleepy drivers.


Sponsor

Flinders University of South Australia

Enrollment

30 participants

Start Date

Nov 23, 2021

Study Type

Interventional

Conditions

Summary

This project will investigate how VOMS assessments, measured by the Neuroflex®, can identify sleepiness that affects the performance of driving tasks. Your participation in this project will involve visiting the Flinders Health and Medical Research Institute Sleep Health group laboratory (located in the Mark Oliphant Building, Bedford Park) for a 2-hour introductory laboratory visit. You will then be asked to complete 7-days of monitoring of your sleep and daytime activity at home with an activity monitor worn on your wrist before returning to the laboratory. During your experimental laboratory visit you will first undergo an overnight sleep study followed by the next day and night of performance testing until you finish the protocol at 1pm (i.e., 2 nights and 1.5 days in the laboratory)


Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 35 Yearss

Plain Language Summary

Simplified for easier understanding

Drowsy driving is a major cause of road accidents, but it can be difficult to detect objectively — especially before a driver realises they are sleepy. This study is exploring whether tests of eye movement and balance (called vestibular-ocular motor screening, or VOMS) can reliably identify when someone is too sleepy to drive safely. These tests are quick and non-invasive, and could one day be used at roadsides or in workplaces to detect fatigue. The study involves a 2-hour introductory visit, a week of wearing a wrist activity monitor at home, and then a longer laboratory stay involving a controlled sleep deprivation protocol and driving performance tests. Participants will be assessed with the Neuroflex device, which measures eye movement and balance, at various levels of sleepiness. You may be eligible if you are between 20 and 35 years old, have held a full car licence for at least two years, drive at least 3 hours per week, have regular sleep patterns (roughly 10pm–8am), and score below certain thresholds on sleepiness and sleep disorder questionnaires. Various health conditions, medications, pregnancy, and shift work may affect eligibility.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Materials: Trial of: Vestibular and Ocular Movement (VOMs) assessments conducted with the Neuroflex(R) Virtual Reality (VR) headset device (VR headset hardware= FOVE) used to determine how effective

Materials: Trial of: Vestibular and Ocular Movement (VOMs) assessments conducted with the Neuroflex(R) Virtual Reality (VR) headset device (VR headset hardware= FOVE) used to determine how effective this methodology is for predicting poor driving and cognitive performance. VOMS: VOMs compared to SLEEPINESS as detected by currently accepted methodologies: Karolinska Drowsiness Test (objective sleepiness) and Karolinska Sleepiness Scale (subjective sleepiness). VOMs compared to PERFORMANCE as detected by AusEd driving simulator metrics including speed and steering deviations, and general cognitive performance as detected by psychomotor vigilance task (PVT) metrics including higher reaction time (RT) latencies. Procedures: Driving and cognitive performance will be compared with a mixed subjects design. A) individuals’ performance will be compared within-subject first 1-hour post waking, and second 25-hours post waking. This intervention will provide information about the impact of sleepiness on performance, and the capacity of vestibular and ocular assessments to represent that sleepiness/performance decline. B) the same cohort of participants as that used in the within-subjects analysis will be divided for a between-subjects analysis with those individuals who demonstrate a trait for alertness failure and those who demonstrate a trait for alertness-failure resistance as determined by a cluster analysis that will divide participants into two separate groups. These comparisons will be made at points of critical alertness failure such as the early morning, which will reflect both the impact of sleep restriction and circadian phase on performance and vestibular and ocular assessments. Who and Mode of Delivery and location: Intervention delivered by researcher instructions. Healthy Participants will be invited to the Flinders Health and Medical Research Institute (FHMRI) / Adelaide Institute for Sleep Health (AISH) sleep laboratory to 1) meet a researcher and trial the experimental materials, and 2) to complete a diagnostic sleep study followed by five test batteries interspersed with breaks rotating every 6-hours, including one starting at 1-hour post wake, and the final starting at 25-hours post wake. Between these laboratory visits, participants will complete home activity and sleep monitoring for two weeks. Number of times (including duration/intensity/dose): All Participants will have two-weeks of baseline home observations consisting of 1-week of reporting their natural sleep patterns and 1-week of the same self-selected bed/wake times with 9-hour windows, the timing of which will be replicated during the laboratory phase. Following the night of sleep observed in the FHMRI/AISH sleep laboratory with the self-selected window, participants will remain in the sleep laboratory and undergo one period of wakefulness with cognitive battery assessments between the following hours: Day 1 8am-12.30pm, 2-6:30pm, 8pm-12:30am on day 2, day 2 2-6:30am, 8am-12.30pm. The order of testing in each battery is as follows: VOMs assessments pre and post the Aused driving simulator, followed by the objective and subjective sleepiness assessments with the Karolinska Drowsiness Test and Karolinska Sleepiness Scale and vigilance tasks with the Psychomotor Vigilance Task following the post-driving simulator VOMS. Adherence: Recruitment/adherence etc. will be monitored and represented in a consort diagram as relevant to published and presented works that are derived from this study.


Locations(1)

SA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12621001610820