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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]

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

sleep disorder

insomnia

depression

stress

anxiety

poor cognitive performance

Condition category

Condition code

Mental Health

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]

Lifestyle

Intervention code [2]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Changes in sleep from baseline, using the Insomnia Severity Index and the PROMIS Sleep-Related Impairment Scale.

Timepoint [1]

Midpoint (i.e., Week 2 of the intervention) and end of the intervention (i.e., beginning of week 5)

Primary outcome [2]

Changes in cognitive performance from baseline, using average scores for Psychomotor Vigilance Task and N-back Task.

Timepoint [2]

Midpoint (i.e., Week 2 of the intervention) and end of the intervention (i.e., beginning of week 6)

Primary outcome [3]

Perceived satisfaction with the app using rating scale.

Timepoint [3]

In the week following the end of the intervention (i.e., week 5)

Secondary outcome [1]

Primary outcome: Changes in mental health from baseline, using Depression, Stress and Anxiety Scale - 21 items.

Timepoint [1]

In the week following the end of the intervention (i.e., week 5)

Secondary outcome [2]

Practicality, measured passively using engagement data from the app (such as minutes of app use during a week).

Timepoint [2]

Duration of weekly app use (in minutes), reported for each week during intervention

Secondary outcome [3]

Implementation, measured as participant retention rate

Timepoint [3]

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]

Implementation, measured as intervention adherence (actual sleep window in relation to sleep recommendations)

Timepoint [4]

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]

Changes in sleep measures from baseline, for PROMIS Sleep disturbance

Timepoint [5]

Measured midpoint (i.e. Week 4 of the intervention) and end of the intervention (beginning of Week 5).

Secondary outcome [6]

Changes in cognitive performance using the Balloon Analog Risk Taking Test.

Timepoint [6]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Defence, Science and Technology Group (DSTG)

Address [1]

DST Edinburgh
PO Box 1500
Edinburgh SA 5111

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Defence, Science and Technology Low-Risk Human Ethics Committee

Ethics committee address [1]

DST Edinburgh
PO Box 1500
Edinburgh SA 5111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/04/2022

Approval date [1]

02/05/2022

Ethics approval number [1]

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

Dr Prerna Varma

Address

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

Australia

Phone

+61 399050150

Fax

[email protected]

Contact person for public queries

Name

Prerna Varma

Address

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

Australia

Phone

+61 399050150

Fax

[email protected]

Contact person for scientific queries

Name

Prerna Varma

Address

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

Australia

Phone

+61 399050150

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
16306	Study protocol				Study protocol will be published in a peer-reviewe... [More Details]

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.

Trial Review

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