Examining the efficacy of a sleep-wake management tool for younger and older shift workers

Not Applicable

Recruiting

• Conditions: shift work disorder; sleep disorder; insomnia; depression; poor cognitive performance; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12622000840785
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-15
• Last Update Posted: 5 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Aged 21 years or above.
2.Employed in rotational or night shift work for a minimum of one year.

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 an 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 substance use in the past 12 months.
8.Investigational drug use in the past 60 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in sleep from baseline, using the Insomnia Severity Index and PROMIS sleep-related impairment scale.[Midpoint (i.e. Week 2 of the intervention) and the end of the intervention (i.e.f beginning of Week 5). ];Acceptability, measured as perceived satisfaction with the app using rating scale.[In the week following the end of the intervention (i.e., week 5)];Changes in cognitive performance from baseline, measured using Psychomotor vigilance task and N-back[Midpoint (i.e. Week 2) and end of the intervention (week 5)]

Secondary Outcome Measures

Name	Time	Method
Practicality, measured passively using engagement data from the app (such as minutes of app use during a week).[Duration of weekly app use (in minutes), reported for each week during intervention];Implementation, measured as intervention adherence (actual sleep window in relation to sleep recommendations)[Measured daily using a sleep diary on the app where participants note their bedtimes and waketimes. Daily overlap between sleep recommendations and actual sleep behaviours 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).];Implementation, measured as participant retention rate[After the end of data collection period, by examining how many people started the study and how many people completed the final survey for the study (week 5). ]