Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001610820
Ethics application status
Approved
Date submitted
11/10/2021
Date registered
26/11/2021
Date last updated
2/11/2022
Date data sharing statement initially provided
26/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determining the effectiveness of vestibular (balance) and ocular (eye movement) motor function screening assessments for identifying sleepy drivers.
Scientific title
Determining the effectiveness of vestibular and ocular motor function screening assessments for identifying sleepy drivers.
Secondary ID [1] 305512 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep deprivation and human performance. 323904 0
Condition category
Condition code
Neurological 321420 321420 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321915 0
Behaviour
Intervention code [2] 321916 0
Lifestyle
Comparator / control treatment
There are two comparator conditions in this investigation. A) performance will be compared within-subjects pre and post the sleep deprivation period of 24+1 hours. B) performance will be compared between-subjects of existing groups that demonstrate alertness-failure vulnerability and subjects that demonstrate alertness-failure resistance.
Control group
Active

Outcomes
Primary outcome [1] 329193 0
The sensitivity and specificity relationship between Vestibular and Ocular Movement (VOMs) assessments delivered via a Virtual Reality (VR) headset from Neuroflex (R) to both objective and subjective sleepiness between timepoints A and B that represent a full day of sleep deprivation.
VOMs assessments include metrics such as: accuracy (in degrees) and latency (in milliseconds), of eye-movements in response to stimuli as presented on the VR headset. Increases in latency and higher variations in degrees represent poorer performance.
Objective sleepiness metrics include changes in Alpha wave power as determined by electroencephalography (EEG) between eye-open and eyes-closed conditions of the Karolinska Drowsiness Task (KDT). Increased alpha activity in the eyes-closed condition relative to the eyes-open condition represents increased levels of sleepiness.
Subjective sleepiness is represented with Karolinska Sleepiness Scale (KSS) with 4 items that represent sleepiness (=>6) and 4 items that represent alertness (=<4). With 5 representing a neutral state.
Timepoint [1] 329193 0
Timepoint A= 1-hour post wake at 8am.
Timepoint B= 25-hours post wake at 8am.
Primary outcome [2] 329194 0
To determine the sensitivity and specificity of Vestibular and Ocular Movement (VOMs) assessments delivered via a Virtual Reality (VR) headset from Neuroflex (R) to driving performance between timepoints A and B that represent a full day of sleep deprivation.
VOMs assessments include metrics such as: accuracy (in degrees) and latency (in milliseconds), of eye-movements in response to stimuli as presented on the VR headset.
Driving performance metrics include speed and lane deviations, and reaction time scores for braking to truck stimuli as recorded on the AusEd driving simulator. Performance declines are represented in greater speed and lane deviation in frequency, and by increases in reaction times (in milliseconds) in braking in response to truck stimuli.
Timepoint [2] 329194 0
Timepoint A= 1-hour post wake at 8am.
Timepoint B= 25-hours post wake at 8am.
Primary outcome [3] 329469 0
To determine the sensitivity and specificity of Vestibular and Ocular Movement (VOMs) assessments delivered via a Virtual Reality (VR) headset from Neuroflex (R) to cognitive performance between timepoints A and B that represent a full day of sleep deprivation.
VOMs assessments include metrics such as: accuracy (in degrees) and latency (in milliseconds), of eye-movements in response to stimuli as presented on the VR headset.
Cognitive performance metrics include reaction time increases to stimuli presented on the psychomotor vigilance task (PVT). Performance declines are represented by an increase in reaction time (in milliseconds) to the stimuli.
Timepoint [3] 329469 0
Timepoint A= 1-hour post wake at 8am.
Timepoint B= 25-hours post wake at 8am.
Secondary outcome [1] 401744 0
To determine the relationship between (subjective and objective) sleepiness and driving performance for individuals who are A) vulnerable to alertness-failure, and B) resistant to alertness-failure between the baseline and critical timepoint.
Cluster analysis will determine statistically independent groups of individuals who are either vulnerable or resistant to alertness failure at the critical timepoint.
Objective sleepiness metrics include changes in Alpha wave power as determined by electroencephalography (EEG) between eye-open and eyes-closed conditions of the Karolinska Drowsiness Task (KDT). Increased alpha activity in the eyes-closed condition relative to the eyes-open condition represents increased levels of sleepiness.
Subjective sleepiness is represented with Karolinska Sleepiness Scale (KSS) with 4 items that represent sleepiness (=>6) and 4 items that represent alertness (=<4). With 5 representing a neutral state.

Driving performance metrics include speed and lane deviations, and reaction time scores for braking to truck stimuli as recorded on the AusEd driving simulator. Performance declines are represented in greater speed and lane deviation in frequency, and by increases in reaction times (in milliseconds) in braking in response to truck stimuli.
Timepoint [1] 401744 0
Baseline timepoint= 1-hour post wake on day 1.
Critical timepoint= Performance battery 4 at 2am of day 2. At this time the combined sleepiness and circadian pressure will ensure that subjects are most likely to perform their poorest.
Secondary outcome [2] 402721 0
To determine the relationship between (subjective and objective) sleepiness and cognitive performance for individuals who are A) vulnerable to alertness-failure, and B) resistant to alertness-failure between the baseline and critical timepoint.
Cluster analysis will determine statistically independent groups of individuals who are either vulnerable or resistant to alertness failure at the critical timepoint.
Objective sleepiness metrics include changes in Alpha wave power as determined by electroencephalography (EEG) between eye-open and eyes-closed conditions of the Karolinska Drowsiness Task (KDT). Increased alpha activity in the eyes-closed condition relative to the eyes-open condition represents increased levels of sleepiness.
Subjective sleepiness is represented with Karolinska Sleepiness Scale (KSS) with 4 items that represent sleepiness (=>6) and 4 items that represent alertness (=<4). With 5 representing a neutral state.
Cognitive performance metrics include reaction time increases to stimuli presented on the psychomotor vigilance task (PVT). Performance declines are represented by an increase in reaction time (in milliseconds) to the stimuli.
Timepoint [2] 402721 0
Baseline timepoint= 1-hour post wake on day 1.
Critical timepoint= Performance battery 4 at 2am of day 2. At this time the combined sleepiness and circadian pressure will ensure that subjects are most likely to perform their poorest.

Eligibility
Key inclusion criteria
Inclusion – eligible participants must meet all of the following criteria:
Basic
- Held their full car license (class C) for a minimum of two years
- Drive at least 3 hours per week
- Bedtime 2200 ±2hrs; waketime 0800 ±2hrs; between 6-11 hours in bed
- Reading/Speaking English fluency
- Able to give informed, written consent
- Age/gender matched (i.e., aim to recruit equal numbers of male/female participants whose ages match to ensure a representative sample of individuals in this age group (20-35 years old)
Comprehensive/Questionnaires
- Insomnia Severity Index (ISI) <10
- Epworth Sleepiness Score (ESS) <10
- OSA 50 <5
Minimum age
20 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion – eligible participants will not exhibit any of the following:
- Active Health/mental health/sleep conditions that alter sleep; or BMI >35
- History of TBI, stroke, or neurodegenerative disorder (Parkinson’s disease, Dementia)
- Active use of OTC or prescription medications that alter sleep (previous 2 months)
- Active illicit substance use (previous 2 months)
- Elevated alcohol and caffeine use (>4 x alcohol and/or caffeine drinks per day; OR >10 alcoholic drinks per week)
- Smoking dependence (non-casual smoking)
- Pregnancy, lactating, or caring for a newborn (12 months and under)
- Recent overnight shift workers (working 2300-0600 at least once per week in previous 2 months); recent time-zone travel encompassing >2 zones (previous 2 months)

Study design
Purpose of the study
Diagnosis
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
Other
Other design features
For the within-subjects sections of the analysis, individuals post-sleep deprivation performance will be compared to their baseline (1-hour post-sleep) performance. For the between-subjects analyses, the same cohort of individuals will be split into two groups to be compared on the basis of a cluster analysis that will determine those who are vulnerable to alertness failure vs. resistant to alertness failure. Participants in the vulnerable group will demonstrate statistically worse performance on the driving simulator lane deviation metric post sleep-deprivation, than the alertness failure resistant group. Performance between the vulnerable vs. resistant groups of participants will be compared.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For the initial pilot of VOMs for determining sleepiness and driving/cognitive performance we aim to examine 30 healthy subjects between the ages of 20-35. Further studies within this same trial may include older subject groups or those with existing sleep disorders.

Statistical comparisons will be made with Receiver Operator Curves (ROC) that determine the sensitivity/sensitivity of the VOMs assessments to sleepiness and performance outcomes. Comparator groups for the ROC analyses will be determined with a) +-2 standard deviations from the mean at the baseline compared to the sleep deprived state, and b) cluster analyses of performance and sleepiness.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/11/2021
Date of last participant enrolment
Anticipated
1/03/2023
Actual
Date of last data collection
Anticipated
30/03/2023
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 35514 0
5000 - Adelaide
Recruitment postcode(s) [2] 35515 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 309878 0
Government body
Name [1] 309878 0
Department of Infrastructure, Transport, Regional Development and Communications
Country [1] 309878 0
Australia
Funding source category [2] 309883 0
Commercial sector/Industry
Name [2] 309883 0
Neuroflex / Saccade Analytics
Country [2] 309883 0
Canada
Primary sponsor type
University
Name
Flinders University of South Australia
Address
Flinders University of South Australia, Sturt Road, Bedford Park, SA, 5042
Country
Australia
Secondary sponsor category [1] 310909 0
None
Name [1] 310909 0
Address [1] 310909 0
Country [1] 310909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309607 0
Flinders University Human Research Ethics Committee (HREC)
Ethics committee address [1] 309607 0
Flinders University of South Australia, Sturt Road, Bedford Park, SA, 5042
Ethics committee country [1] 309607 0
Australia
Date submitted for ethics approval [1] 309607 0
01/08/2021
Approval date [1] 309607 0
15/09/2021
Ethics approval number [1] 309607 0
4648

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

Contacts
Principal investigator
Name 114750 0
A/Prof Andrew Vakulin
Address 114750 0
AISH:FCRE, Flinders University
Box 6, Mark Oliphant Building
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 114750 0
Australia
Phone 114750 0
+61 08 72218308
Fax 114750 0
Email 114750 0
andrew.vakulin@flinders.edu.au
Contact person for public queries
Name 114751 0
Miss Kelsey Bickley
Address 114751 0
AISH:FCRE, Flinders University
Box 6, Mark Oliphant Building
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 114751 0
Australia
Phone 114751 0
+61 08 82018306
Fax 114751 0
Email 114751 0
kelsey.bickley@flinders.edu.au
Contact person for scientific queries
Name 114752 0
A/Prof Andrew Vakulin
Address 114752 0
AISH:FCRE, Flinders University
Box 6, Mark Oliphant Building
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 114752 0
Australia
Phone 114752 0
+61 08 72218308
Fax 114752 0
Email 114752 0
andrew.vakulin@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are ethically obligated to protect participant data from the commercial interests in this study. Therefore we cannot make our data publicly available without also making that data available to commercial groups.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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