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Trial registered on ANZCTR


Registration number
ACTRN12621000132842
Ethics application status
Approved
Date submitted
2/09/2020
Date registered
9/02/2021
Date last updated
9/02/2021
Date data sharing statement initially provided
9/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating Driver Sleepiness and Crash Risk in Young Drivers: A Randomized Control Trial to Optimise Sleep
Scientific title
Investigating the effect of a sleep scheduling intervention on driving risk in young drivers: A randomised control trial
Secondary ID [1] 301711 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Driver sleepiness
 318166 0
Sleep loss 318322 0
Condition category
Condition code
Public Health 316183 316183 0 0
Health promotion/education
Injuries and Accidents 317383 317383 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of two parts, a sleep scheduling component and an educational component. Following a two week period of baseline naturalistic sleep assessment, the intervention group will be prescribed a 20% increase in time-in-bed, to be maintained for a period of three weeks. This new sleep time will be prescribed by a qualified sleep researcher. In the naturalistic sleep assessment, participants will answer will complete the daily sleep dairy for 14 days. During this time, the intervention group will also be asked to engage with a series of educational modules (4 x 10 minute videos covering the benefits of sleep, consequences of poor sleep, strategies for sleep management, and associated learning quizzes). The link for the education modules will be texted to the participants phone for easy access, they can view the video modules at any time but the quizzes will only be tested once and will be done through REDCAP. These education modules were developed by the research team and filmed on location. The overall intervention period is 5 weeks long and a 6 month follow up at the conclusion of the intervention period.

The in-car assessment will involve an accelerometer that measures movement in three dimensions This device will be provided to participants during the initial session and will be secured in the boot space of their car. Participants are not required to undertake any special driving tasks while the device is in their car. The devices are programmed to record over the same duration as the intervention period.
Intervention code [1] 318063 0
Behaviour
Intervention code [2] 318828 0
Prevention
Comparator / control treatment
During the three week intervention period, the control arm of the study will undergo an educational module program identical to the active intervention with respect to exposure (time-matched) and modality, but will replace the sleep-related education with diet & nutrition related education. This module was designed specifically for this study arm. No changes in sleep timing will be prescribed. They will follow a naturalistic sleep assessment where they will be filling in a 14 day sleep diary same as the intervention group. The control group will follow the same protocols as the intervention group
Control group
Active

Outcomes
Primary outcome [1] 324430 0
Primary Sleep Outcomes measured;
- Objective habitual daily sleep duration (actigraphy and sleep diary assessed)
Timepoint [1] 324430 0
Outcomes will be assessed continuously for two weeks at a time at Baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Primary outcome [2] 324438 0
Primary Driving Risk Outcome measured;

- Frequency of elevated g-force events (assessed via in-vehicle accelerometry)
Timepoint [2] 324438 0
Elevated g-forces will be measured continuously using in-vehicle accelerometers for two weeks at a time during Baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Primary outcome [3] 325935 0
Primary sleep outcome measured:
- Frequency of sleep restriction (frequency count of sleep duration < 6hrs per night each week) - measured using actigraphy watches
Timepoint [3] 325935 0
Outcomes will be assessed continuously for two weeks at a time at Baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [1] 384613 0
Sleep Quality - PROMIS Sleep disturbance scale
Timepoint [1] 384613 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [2] 387994 0
Subjective Daytime Alertness (PROMIS Sleep Related Impairment Scale)
Timepoint [2] 387994 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [3] 387995 0
Subjective sleepiness (Karolinska Sleepiness Scale)
Timepoint [3] 387995 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [4] 387996 0
Objective state sleepiness: (Psychomotor Vigilance Task)
Timepoint [4] 387996 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [5] 387997 0
Objective state sleepiness: Electroencephalography (EEG)
Timepoint [5] 387997 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [6] 387998 0
Objective state sleepiness: Electrocardiography
Timepoint [6] 387998 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [7] 387999 0
Objective state sleepiness: Phasya drowsiness monitoring glasses
Timepoint [7] 387999 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [8] 388000 0
Dimensional Card Sort Test: NIH Toolbox
Timepoint [8] 388000 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [9] 388001 0
Flanker Inhibitory control task: NIH Toolbox
Timepoint [9] 388001 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [10] 388002 0
Alcohol Use: PROMIS Alcohol Short form
Timepoint [10] 388002 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [11] 388003 0
Social Isolation: PROMIS Social Isolation
Timepoint [11] 388003 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [12] 388004 0
Stress: Perceived Stress Scale
Timepoint [12] 388004 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [13] 388005 0
Emotion: Emotion Regulation Questionnaire
Timepoint [13] 388005 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [14] 388006 0
Depression: PROMIS Depression Short form
Timepoint [14] 388006 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [15] 388007 0
Anxiety: PROMIS Anxiety Short form
Timepoint [15] 388007 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [16] 388008 0
Bedtime behaviour: Bedtime Procrastination Scale
Timepoint [16] 388008 0
Measured once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [17] 389596 0
Primary Driving Risk Outcome measured;

- lateral lane variability (assessed via driving simulator)
Timepoint [17] 389596 0
Lateral lane variability will be assessed once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).
Secondary outcome [18] 389597 0
Lane deviation (assessed via driving simulator)
Timepoint [18] 389597 0
Lane deviation will be assessed once in-laboratory following each two-week assessment time-point at baseline (Study weeks 1 and 2), Post-intervention (Study weeks 7 and 8), and Follow-up (Study weeks 33 and 34).

Eligibility
Key inclusion criteria
Potential participants will be required to meet the following criteria;
- Regular driver with current Australian driver’s license (Provisional or Open)
- Sleep for less than 7hrs per night on average, and less than 6hrs per night on at least 2 occasions per week;
- Willing to make a change to a sleep or nutrition related lifestyle behaviour;
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Key exclusion criteria include;
- Currently working overnight shifts (i.e. any shifts falling between the hours of 12am – 6am);
- Have travelled across more than three time zones within the past three months or intend to travel within the first three months of the study;
- Have a current medically diagnosed sleep disorder (e.g. Obstructive Sleep Apnoea etc.);
- Have a current medically diagnosed eating disorder;
- Currently use medically prescribed stimulants, antidepressants, antianxiety, antipsychotic, mood stabilising medications, sleep medications or appetite suppressants;
- Currently use over-the-counter substances with psychoactive properties (e.g., Ginkgo Biloba, St. John’s Wort);
- Women who are pregnant or who are planning to become pregnant in the next 10 months;
- Parents or sole carers of a child;
- Regular smoker

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation by contacting the holder of the allocation schedule (not present during recruitment).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer sequence generated randomisation table (RedCap)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses of change in the primary outcomes will be conducted on an intention-to-treat (ITT) basis. Changes in sleep indicators (sleep duration, frequency of sleep restriction) and risky driving indicators (g-forces and lateral lane positioning) will be tested with linear mixed-model repeated measures analyses. We will report significance (as confidence intervals) and magnitude estimates to guide clinical interpretation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/08/2020
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
210
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 30754 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 306148 0
Government body
Name [1] 306148 0
National Health and Medical Research Council
Country [1] 306148 0
Australia
Primary sponsor type
University
Name
Institute for Social Science Research - University of Queensland
Address
80 Meiers Rd
Indooroopilly QLD 4068
Country
Australia
Secondary sponsor category [1] 306754 0
None
Name [1] 306754 0
Address [1] 306754 0
Country [1] 306754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306366 0
University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 306366 0
The University of Queensland, Cumbrae-Stewart Building, Research Road, Brisbane QLD 4072
Ethics committee country [1] 306366 0
Australia
Date submitted for ethics approval [1] 306366 0
28/05/2019
Approval date [1] 306366 0
26/08/2019
Ethics approval number [1] 306366 0
2019001269

Summary
Brief summary
Road crashes are a major cause of death and disability for young Australians. Fatigue is a major contributor to road crash, and is primarily due to insufficient sleep. Young adults frequently lose sleep due to developmental, social, work, and education demands. This project uses a brief but potentially powerful behavioural program to extend habitual sleep, reduce sleepiness while driving, and reduce driving risk. The program could reduce the very high medical, social, and individual costs of road trauma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103626 0
Prof Simon Smith
Address 103626 0
Institute for Social Science Research,
University of Queensland,
80 Meiers Rd,
Indooroopilly QLD 4068
Country 103626 0
Australia
Phone 103626 0
+61 7 334 67812
Fax 103626 0
Email 103626 0
[email protected]
Contact person for public queries
Name 103627 0
Dr Shamsi Shekari Soleimanloo
Address 103627 0
Institute for Social Science Research,
University of Queensland,
80 Meiers Rd,
Indooroopilly QLD 4068
Country 103627 0
Australia
Phone 103627 0
+61 7 334 67805
Fax 103627 0
Email 103627 0
[email protected]
Contact person for scientific queries
Name 103628 0
Prof Simon Smith
Address 103628 0
Institute for Social Science Research,
University of Queensland,
80 Meiers Rd,
Indooroopilly QLD 4068
Country 103628 0
Australia
Phone 103628 0
+61 7 334 67812
Fax 103628 0
Email 103628 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.