Sleep Schedule Intervention Study Among Night Shift Workers

Not Applicable

Completed

• Conditions: Shift Work Schedule
• Interventions: Behavioral: Morning sleep schedule; Behavioral: Evening sleep schedule

• Registration Number: NCT04160572
• Lead Sponsor: China Medical University Hospital

Brief Summary

This study will recruit 60 night shift workers with shift work disorder. They will be invited to wear actigraphy for 3 weeks. In the first week the participants will sleep at the time they used to, and their chronotype will be determined by actigraphy and Munich Chronotype Questionnaire. In the second week the participants will be randomly assigned to morning sleep or evening sleep time, and will change to the other in the third week. We will compare sleepiness, sleep quality, daytime vigilance score changes using mixed method ANOVA. We will also examine the interaction effect of chronotype and sleep schedule on sleep-related outcome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-09
• Study First Posted: 2019-11-13
• Study Start: 2019-12-17
• Primary Completion: 2020-12-23
• Status Verified: 2021-07
• Study Completion: 2021-07-27
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Shift work disorder

Exclusion Criteria

• Neuromuscular disorder
• Taking hypnotics
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Morning-evening sleep schedule	Evening sleep schedule	-
Morning-evening sleep schedule	Morning sleep schedule	-
Evening-morning sleep schedule	Morning sleep schedule	-
Evening-morning sleep schedule	Evening sleep schedule	-

Primary Outcome Measures

Name	Time	Method
Sleep quality	Change from baseline score at the second and third week.	Pittsburgh sleep quality index (PSQI), range from 0 (better) to 21 (worse)

Secondary Outcome Measures

Name	Time	Method
Daytime sleepiness	Change from baseline score at the start and end of each night shift.	Karolinska Sleepiness Scale (KSS), range from 1 (better) to 9 (worse)
Alertness	Change from baseline score at the start and end of each night shift.	Psychomotor vigilance test (PVT), reaction time (longer the worse) and lapses (larger the worse)

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung City, Taiwan