Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000339550
Ethics application status
Approved
Date submitted
7/01/2024
Date registered
26/03/2024
Date last updated
26/03/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep check before shift work: The effectiveness of a sleep education, screening, and management approach to prevent road trauma in Australia’s young adults.
Scientific title
Sleep check before shift work: The effectiveness of a sleep education, screening, and management approach to prevent road trauma in Australia’s young adults.
Secondary ID [1] 311135 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep disorders 332294 0
road accidents 332295 0
Help seeking behaviour 332296 0
Fatigued driving 333336 0
Condition category
Condition code
Injuries and Accidents 329009 329009 0 0
Other injuries and accidents
Public Health 329010 329010 0 0
Health service research
Respiratory 329011 329011 0 0
Sleep apnoea
Mental Health 329186 329186 0 0
Other mental health disorders
Neurological 329459 329459 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to determine if sleep disorder education combined with an in-laboratory shift work simulation experience will improve help seeking for sleep problems in young Australians before they are required to work regular shift work in the healthcare industry.

Participants who screen positive for a sleep disorder will be randomised to one of three study arms including
1) sleep education only arm,
2) sleep education + simulated night shift arm or
3) sleep education + simulated night shift + personalised performance feedback.

In all three of the study arms participants will be invited to the Flinders Health and Medical Research Institute (Sleep Health)/Adelaide Institute for Sleep Health sleep laboratory to perform an overnight level one diagnostic sleep study in line with best clinical practice.

Clinical interviews will be conducted by a sleep physician and/or sleep psychologist as required to confirm sleep diagnoses. The same education module (~15min) will be provided to all 3 arms prior to their overnight laboratory stay.

The sleep study will commence at the participant's habitual bedtime derived from sleep diary reports during the baseline sleep monitoring period. The extended wakefulness protocol will commence 9hrs after each participant's lights off time on the sleep study night.

Following the in-laboratory sleep study, participants in arms 2 and 3 will undergo their respective shift work simulation protocols (intervention) while participants in arm one, who represent the control arm, will not undertake further laboratory testing. They will be informed of their sleep disorder diagnosis, and recommended to seek appropriate health care (see 'Diagnostic Appointments' below).

Adherence to the shift work simulation (extended wakefulness) will be monitored by research technician staff on shift. The extended wakefulness period will include repeated cognitive testing batteries assessing cognitive capabilities and reaction time. Circadian rhythms from melatonin and core body temperature will also be monitored. The extended wakefulness period will include simulated driving tests to monitor driving performance across the extended wake period.

Immediately post completion of the simulated shift work arm, study participants in Arms 2 & 3 will undertake a second sleep study as a recovery sleep in the sleep laboratory before leaving the laboratory.

Intervention arms

Intervention arm 2
Immediately after the overnight sleep study, participants in arm 2 of the study will undertake a ~30-hour period of extended wakefulness to simulate shift work. Participants will undergo a range of tasks to assess their cognitive performance and mood at unpredictable times throughout the extended wakefulness period. Tasks will include driving in a simulator, reaction time tasks and eye movement assessments using a virtual reality headset. Physiological information on core body temperature using e-Celcius BodyCaps will be collected to assess circadian phase throughout the laboratory stay.

Intervention arm 3
The third intervention arm will follow the same procedures as arm 2 with the addition of tailored driving and cognitive performance feedback for each participant. Specifically, an independent feedback session on performance and road risk and safety indicators measured during the simulated shift will be provided to participants. Feedback will be provided by key research personnel (PhD candidates, Research Associate or Investigators) and will be standardised to report their level of impairment during their shift simulation, with metrics such as percentage of road incidents and average lane deviation on simulated driving tasks, and performance on test batteries. This will be reported for each individual relative to their own performance when not sleep deprived. This feedback will be provided during a 30-60 minute individual consultation between the participant and researcher(s).

Diagnostic appointments
After completion of either the overnight sleep study (Arm 1) or the laboratory component with recovery sleep (arms 2 and 3), participants from all study arms will have a scheduled sleep disorder diagnostic appointment booked with a sleep physician and/or sleep psychologist at the Flinders Health and Medical Research Institute sleep clinic. During the appointments, clinicians will provide participants with information about how to access gold standard evidence-based treatment options for potential sleep disorders including sleep apnea, cognitive behavioural therapy for insomnia (CBTi) or related behavioural sleep difficulties or pharmacological management for other sleep disorders as appropriate to the individual.

Participants will be offered gap-free treatment if a subsequent referral is via the Flinders Health and Medical Research Institute (Sleep Health)/Adelaide Institute for Sleep Health sleep clinic. There will be no obligation for participants to engage in these sleep health services, should they prefer an alternative health professional.

Participants will be followed up monthly by text, call and/or email to determine the date of any subsequent appointment(s) with a health professional for sleep. Participants will have a follow-up interview and complete questionnaires relating to their sleep quality, mental health, driving behaviours and reporting of any road incidents at 3, 6,9 and 12 months after their diagnostic appointment.
Intervention code [1] 327583 0
Early detection / Screening
Comparator / control treatment
Participants assigned to arm 1 of the randomised control trial will be an active control group. Participants will be required to complete an online sleep education module, an overnight diagnostic sleep study in the laboratory and a sleep disorder diagnostic appointment with a sleep physician and or sleep psychologist.

Participants will be followed up with the same post-study protocol as participants in Arms 2 and 3 (intervention). Participants will have a follow-up interview and complete questionnaires relating to their sleep quality, mental health and driving behaviors and road incidents at 3, 6,9 and 12 months after their diagnostic appointment.

The education module includes basic sleep health information, symptoms of sleep disorders and common sleep disorders. The sleep education module outlines the impact of sleep disorders on young shift workers, and includes information on prevalence, symptoms and lived experience aimed at young shift workers. It will be presented in the form of a ~15minute online video format which participants will be able to access via an online link. The education module is designed specifically for this trial; completion of the education module will be confirmed by completion of a brief questionnaires after the video.
Control group
Active

Outcomes
Primary outcome [1] 336808 0
Time to first appointment with a health professional specifically for sleep
Timepoint [1] 336808 0
First treatment appointment date within 12 months of follow-up; assessed monthly for 12 months.
Primary outcome [2] 337772 0
Sought help from a healthcare professional specifically for sleep
Timepoint [2] 337772 0
Baseline, followed by 3,6,9 and 12 month follow ups from the sleep disorder diagnostic appointment
Primary outcome [3] 337773 0
Self-reported driving event (yes or no) in the follow-up period
Timepoint [3] 337773 0
Baseline, 3,6,9 and 12 months
Secondary outcome [1] 429731 0
Depressive symptoms
Timepoint [1] 429731 0
Baseline, followed by 3,6,9 and 12 months followup from the sleep disorder diagnostic appointment
Secondary outcome [2] 429733 0
Anxiety symptoms
Timepoint [2] 429733 0
Baseline, followed by 3,6,9 and 12 months followup from the sleep disorder diagnostic appointment
Secondary outcome [3] 430006 0
Sleep quality (objective)
Timepoint [3] 430006 0
Baseline, followed by 3,6,9 and 12 months followup from the sleep disorder diagnostic appointment
Secondary outcome [4] 430007 0
Self-reported sleep quality
Timepoint [4] 430007 0
Baseline, followed by 3,6,9 and 12 months followup from the sleep disorder diagnostic appointment
Secondary outcome [5] 430008 0
Self-reported sleepiness
Timepoint [5] 430008 0
Baseline, followed by 3,6,9 and 12 months followup from the sleep disorder diagnostic appointment
Secondary outcome [6] 430009 0
Self-reported fatigue
Timepoint [6] 430009 0
Baseline, followed by 3,6,9 and 12 months followup from the sleep disorder diagnostic appointment
Secondary outcome [7] 430434 0
Quality of life
Timepoint [7] 430434 0
Baseline, followed by 3,6,9 and 12 months followup from the sleep disorder diagnostic appointment
Secondary outcome [8] 433282 0
Acceptability of intervention design
Timepoint [8] 433282 0
Baseline, followed by 3,6,9 and 12 months followup from the sleep disorder diagnostic appointment
Secondary outcome [9] 433283 0
Appropriateness of intervention design
Timepoint [9] 433283 0
Baseline, followed by 3,6,9 and 12 months followup from the sleep disorder diagnostic appointment
Secondary outcome [10] 433284 0
Feasibility of intervention design
Timepoint [10] 433284 0
Acceptability of Intervention Measure (AIM), a composite measure of 4 questions on a Likert scale

Eligibility
Key inclusion criteria
- 18 -39 years of age
- Hold a full (Class C) or provisional (Class B) car license or equivalent
- Drive at least 1 hour per week
- Read and speak English fluently
- Able to provide informed written consent
- Be currently enrolled in a tertiary study degree in Paramedicine, Nursing or Medicine

Screen on comprehensive questionnaires as likely to be at risk of a sleep disorder by meeting one or more of the below criteria:
- Insomnia Severity Index >8
- ESS>10 indicating high sleepiness.
- Screen as highly likely to have OSA on the STOP-BANG questionnaire
- Indication of an ICSD-3 or DSM-V-TR sleep disorder according to clinical interview with either a sleep physician or sleep psychologist
Minimum age
18 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if:
- They have ingested, inhaled, or injected any illicit drugs or cannabis in the previous 4 weeks or have drug dependencies that would mean they could not abstain for the duration of the extended wakefulness protocol.
- They have unmanaged suicidal ideation or intent.
- They have a history of traumatic brain injury, stroke, neurogenerative disorders (Parkinson’s disease, Dementia)
- They have a smoking dependence (non-casual smoking) which would prevent them from remaining in the laboratory to complete the study.
- They are pregnant, lactating, or caring for a newborn (under 12months of age).
- Will be required to undertake shift work between the hours of midnight and 5am in the three days prior to their scheduled laboratory stay.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be decided by random sequence generation by research staff not involved in the diagnosis process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/04/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315392 0
Government body
Name [1] 315392 0
Lifetime Support Authority
Country [1] 315392 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
5 Laffer Drive, Bedford Park
Country
Australia
Secondary sponsor category [1] 317455 0
None
Name [1] 317455 0
Address [1] 317455 0
Country [1] 317455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314309 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 314309 0
Registry Building, Basement Flinders University Bedford Park SA 5042
Ethics committee country [1] 314309 0
Australia
Date submitted for ethics approval [1] 314309 0
27/11/2023
Approval date [1] 314309 0
04/01/2024
Ethics approval number [1] 314309 0
6548

Summary
Brief summary
One in five young Australian adults have a sleep problem which warrants clinical review. Most of the time, these sleep problems are not well managed. One in four young Australians also work shift work. The combination of shift work and an unmanaged sleep problem can put young adults at risk of road safety incidents. The overall purpose of this study is to determine whether a sleep education module followed by experience of a shift work simulation, can support faster access to appropriate health services for sleep.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131138 0
A/Prof Amy Reynolds
Address 131138 0
AISH/FHMRI (Sleep Health) Level 3, 5 Laffer Drive, Bedford Park, SA, 5042
Country 131138 0
Australia
Phone 131138 0
+61 8 8201 5196
Fax 131138 0
Email 131138 0
amy.reynolds@flinders.edu.au
Contact person for public queries
Name 131139 0
A/Prof Amy Reynolds
Address 131139 0
AISH/FHMRI (Sleep Health) Level 3, 5 Laffer Drive, Bedford Park, SA, 5042
Country 131139 0
Australia
Phone 131139 0
+61 8 8201 5196
Fax 131139 0
Email 131139 0
amy.reynolds@flinders.edu.au
Contact person for scientific queries
Name 131140 0
A/Prof Amy Reynolds
Address 131140 0
AISH/FHMRI (Sleep Health) Level 3, 5 Laffer Drive, Bedford Park, SA, 5042
Country 131140 0
Australia
Phone 131140 0
+61 8 8201 5196
Fax 131140 0
Email 131140 0
amy.reynolds@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


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.