SHIFTPLAN: an RCT Investigating the Effect of a Shift Work Intervention on Fatigue, Sleep and Health. — SHIFTPLAN  

Quality of Life Clinical Trial

Official title: A Randomized Controlled Trial Investigating the Effects of a Multimodal Shift-work Intervention on Drivers' Fatigue, Sleep, Health and Performance Parameters.

Status Not yet recruiting

Clinical Trial Summary

Shift work is associated with disturbed life rhythms resulting from chronic exposure to circadian misalignment and sleep restriction, with long-term participation in most shift schedules causing serious health problems. Epidemiological data show that shift workers are at increased risk of sleepiness, fatigue and insomnia, cardiovascular disease, breast cancer and shift-work disorder. Prevalence estimates of shift-work disorder vary between 5% and 26,5%.

Given these widespread and serious health and functional consequences of shift work, there is a necessity for treatments that improve shift workers' health and work performance. Most non-pharmacological recommendations mention improved scheduling, bright-light exposure, napping, psychoeducation fostering sleep hygiene, and cognitive-behavioral interventions.

The effects of shift work on the health, fatigue and sleepiness of drivers have been robustly investigated in observational studies, as well as the effects of single measures such as scheduling or resting times. But studies on the effectiveness of countermeasures against the adverse impact of shift work are sparse, especially for high-risk populations such as professional drivers and controlled intervention studies are lacking. Several other investigators expounded the need for a multi-level approach to managing occupational sleep-related fatigue and workplace interventions to promote sleep and health of shift workers. Highlighting the high public-health burden associated with lack of recuperative sleep, the authors pointed out the pressing need to develop policies and implement programs aimed at improving workers' sleep health.

With SHIFTPLAN, the investigators aim to fill this gap in comprehensive approaches. To their knowledge, this is the first randomised controlled trial to systematically gauge the effect of a multimodal program that includes ergonomic shift scheduling and an educational program on well-defined health, sleep and performance outcomes in professional drivers.

Clinical Trial Description

The duration of the intervention will be six months. The intervention provided to the intervention group is based on evidence-based good standard of care and includes: 1) Healthy scheduling (fast forward-rotating shift schedules adapted to chronotype, adequate resting times, napping, bright-light therapy); 2) Education program for drivers (psychoeducation promoting sleep hygiene, cognitive-behavioral strategies, stress-management techniques, information on chronotherapy such as bright-light therapy and napping) The control group or "waiting-list group" will include drivers who will continue working according to the default shift schedules while being assigned to a waiting list in anticipation of the education program to which they will able to suscribe after completing the study. ;

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Coping Skills
• Disease
• Fatigue
• Insomnia
• Mental Health Issue
• Quality of Life
• Shift-work Disorder

• NCT number: NCT05452096
• Study type: Interventional
• Source: University Hospital, Antwerp
• Contact: Inge Declercq, MD
• Phone: +3238213938
• Email: inge.declercq@uza.be
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Completion date: August 2023