Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000836730
Ethics application status
Approved
Date submitted
5/06/2022
Date registered
15/06/2022
Date last updated
25/05/2023
Date data sharing statement initially provided
15/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the efficacy of a sleep-wake management tool for shift workers
Scientific title
An open pilot feasibility study to examine the use of a digital shift work app on sleep and cognition in a cohort of Air Traffic Controllers.
Secondary ID [1] 306781 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
shift work disorder 326553 0
sleep disorder 326555 0
insomnia 326556 0
depression 326557 0
stress 326558 0
anxiety 326559 0
poor cognitive performance
 326560 0
Condition category
Condition code
Mental Health 323812 323812 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consenting participants (i.e., individuals undertaking shift work) will receive access to a digital, app-based tool that delivers personalised recommendations for sleep and wake behaviours based on their shift schedules and other personal commitments. The primary strategy from the app includes a sleep-wake schedule (such as: sleep from 10 pm to 7 am, minimum sleep duration of 8 hours in 24 hour period). Other strategies include actionable insights, such as "consume caffeine in xx hours" or "avoid light at xx hours" based on shift timings and personal commitments of the user. Participants will be recommended to engage with the app for approximately five minutes during the day. The app has been designed co-designed with shift workers from healthcare and defence to provide sleep and lifestyle support based on their operational needs.

• Part 1: Baseline testing to identify sleep patterns – Two weeks
Prior to the start of the study, participants will be provided with instructions on how to download and use the app for the first. Once the app is downloaded, it will provide participants with a walkthrough of its features and how participants can add or access shift work-related information. At the start of the first two weeks of the study, participants will receive access to limited features of the app. We will request participants to use these features to record participants bedtime and waketime every day (~2-5 minutes daily).
During the baseline testing period, participants will also be requested to complete: a) an online questionnaire on sleep, chronotype (i.e., participants' body clock) and mental health (once only, ~20 minutes), and b) cognitive testing (up to four times, ~8 minutes each time). The questionnaire can be completed using an online link. Participants can complete cognitive testing at the start and end of participants' shift using an iPad that will be made available at participants base. During these tests, participants will be counted as on-duty.
• Part 2: Using strategies delivered by the app – Up to six weeks
After the first two weeks of the study, participants will receive access to all features of the app. Participants are requested to engage with the app daily to receive strategies and attempt to follow them to the best of participants abilities. During this period, participants will continue to record participants bedtime and waketime every day (~2 minutes daily). Researchers may also request participants to provide a sleep report from participants' smartwatch – this will be optional.
• Part 3: Mid and End of the study testing
During the halfway point of the study (week 4), participants will be requested to complete a short questionnaire on sleep and mood (~5 minutes). Participants will also be requested to complete cognitive testing at the same time during participants shifts as the baseline (up to four times, ~8 minutes each time). At the end of the study, participants will be requested to complete the same questionnaire and cognitive tests from the baseline, which will help us explore any potential changes in sleep and performance following the use of the app. We will also request any feedback on participants' experience using the app, which will help us improve the design and functionalities of the prototype. Participants' adherence to sleep recommendations will be monitored passively, through their responses about bedtime and waketime noted using the sleep diary feature of the app. Engagement with the app will be explored passively by measuring the average minutes of interaction with the app every day.

Intervention code [1] 323726 0
Lifestyle
Intervention code [2] 323727 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331600 0
Changes in sleep from baseline, using the Insomnia Severity Index and the PROMIS Sleep-Related Impairment Scale.
Timepoint [1] 331600 0
Midpoint (i.e., Week 2 of the intervention) and end of the intervention (i.e., beginning of week 5)
Primary outcome [2] 331601 0
Changes in cognitive performance from baseline, using average scores for Psychomotor Vigilance Task and N-back Task.
Timepoint [2] 331601 0
Midpoint (i.e., Week 2 of the intervention) and end of the intervention (i.e., beginning of week 6)
Primary outcome [3] 331639 0
Perceived satisfaction with the app using rating scale.
Timepoint [3] 331639 0
In the week following the end of the intervention (i.e., week 5)
Secondary outcome [1] 410455 0
Primary outcome: Changes in mental health from baseline, using Depression, Stress and Anxiety Scale - 21 items.
Timepoint [1] 410455 0
In the week following the end of the intervention (i.e., week 5)
Secondary outcome [2] 410456 0
Practicality, measured passively using engagement data from the app (such as minutes of app use during a week).
Timepoint [2] 410456 0
Duration of weekly app use (in minutes), reported for each week during intervention
Secondary outcome [3] 410457 0
Implementation, measured as participant retention rate
Timepoint [3] 410457 0
After the end of data collection period, by examining how many people started the study and how many people completed the post-study survey (i.e. survey in Week 5)
Secondary outcome [4] 410620 0
Implementation, measured as intervention adherence (actual sleep window in relation to sleep recommendations)
Timepoint [4] 410620 0
Measured daily from enrollment (week 0) to end of the study (week 5) using a sleep diary on the app where participants note their bedtimes and waketimes. Daily overlap between sleep recommendations and actual sleep behaviours measured from start of the intervention to end of the study (week 5) would be examined as a percentage and reported as an average for each week (e.g., 60% overlap between sleep recommendations and actual sleep behaviours in week 1).
Secondary outcome [5] 410621 0
Changes in sleep measures from baseline, for PROMIS Sleep disturbance
Timepoint [5] 410621 0
Measured midpoint (i.e. Week 4 of the intervention) and end of the intervention (beginning of Week 5).
Secondary outcome [6] 410622 0
Changes in cognitive performance using the Balloon Analog Risk Taking Test.
Timepoint [6] 410622 0
Midpoint (i.e., Week 2 of the intervention) and end of the intervention (i.e., beginning of week 6)

Eligibility
Key inclusion criteria
1. Aged 18 years or above.
2. Employed in rotational shift work for a minimum of one year.
3. Using iOS and Android operating system
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Prior diagnosis of an untreated sleep disorder other than insomnia or shift work sleep disorder (including restless leg syndrome, central or obstructive sleep apnoea, narcolepsy etc.).
2. Prior diagnosis of an untreated medical condition that may impact sleep (including diabetes, thyroid disease, hypertension, neurological conditions etc.).
3. Prior diagnosis of untreated mental health (psychiatric) condition that may impact sleep other than depression or anxiety.
4. Current caffeine consumption >500mg per day
5. Alcohol consumption >20 standard drinks in a week.
6. Transmeridian travel in the past one month.
7. History of illicit substance use in the past 12 months.
8. Investigational drug use in the past 60 days.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pre-post design to examine changes in sleep, cognitive performance and mental health pre-intervention and post-intervention.

Linear mixed models to examine changes in sleep and cognitive performance during the intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/06/2022
Actual
1/07/2022
Date of last participant enrolment
Anticipated
1/05/2024
Actual
Date of last data collection
Anticipated
1/07/2023
Actual
Sample size
Target
40
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311118 0
Government body
Name [1] 311118 0
Defence, Science and Technology Group (DSTG)
Country [1] 311118 0
Australia
Primary sponsor type
Government body
Name
Defence, Science and Technology Group (DSTG)
Address
DST Edinburgh
PO Box 1500
Edinburgh SA 5111
Country
Australia
Secondary sponsor category [1] 312454 0
None
Name [1] 312454 0
Address [1] 312454 0
Country [1] 312454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310648 0
Defence, Science and Technology Low-Risk Human Ethics Committee
Ethics committee address [1] 310648 0
DST Edinburgh
PO Box 1500
Edinburgh SA 5111
Ethics committee country [1] 310648 0
Australia
Date submitted for ethics approval [1] 310648 0
03/04/2022
Approval date [1] 310648 0
02/05/2022
Ethics approval number [1] 310648 0
LD04-22

Summary
Brief summary
More than 15% of the Australian workforce is employed in shift work. However, non-standard work hours may lead to sleep disturbances and circadian misalignment, where our body-clock is not in sync with actual sleep-wake behaviours. This can have adverse effects on overall health and wellbeing, including cognitive performance. In this study, we seek to examine whether using evidence-based strategies delivered via an app, developed in consultation with members of the Australian Defence Force can be a practical way of supporting sleep, mental health and cognitive performance in shift workers. We aim to assess whether the digital tool is appropriate for daily use and whether it has an impact on sleep, mental health and performance of air traffic controllers. Results from this study will help us understand the app's initial efficacy for future testing with larger groups of shift workers.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118386 0
Dr Prerna Varma
Address 118386 0
Dr Prerna Varma/Dr Tracey Sletten
Turner Institute for Brain and Mental Health,
Monash University
Address: Building 2
264 Ferntree Gully, Notting Hill VIC 3168
Country 118386 0
Australia
Phone 118386 0
+61 399050150
Fax 118386 0
Email 118386 0
prerna.varma@monash.edu
Contact person for public queries
Name 118387 0
Dr Prerna Varma
Address 118387 0
Dr Prerna Varma/Dr Tracey Sletten
Turner Institute for Brain and Mental Health,
Monash University
Address: Building 2
264 Ferntree Gully, Notting Hill VIC 3168
Country 118387 0
Australia
Phone 118387 0
+61 399050150
Fax 118387 0
Email 118387 0
prerna.varma@monash.edu
Contact person for scientific queries
Name 118388 0
Dr Prerna Varma
Address 118388 0
Dr Prerna Varma/Dr Tracey Sletten
Turner Institute for Brain and Mental Health,
Monash University
Address: Building 2
264 Ferntree Gully, Notting Hill VIC 3168
Country 118388 0
Australia
Phone 118388 0
+61 399050150
Fax 118388 0
Email 118388 0
prerna.varma@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be collected from members of the Australian Defence Force and given the sensitive nature of the data, it will not be made available publically.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16306Study protocol    Study protocol will be published in a peer-reviewe... [More Details]



Results publications and other study-related documents

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