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Clinical Trials/NCT04160572
NCT04160572
Completed
Not Applicable

Sleep Schedule Intervention Study Among Night Shift Workers

China Medical University Hospital1 site in 1 country60 target enrollmentDecember 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shift Work Schedule
Sponsor
China Medical University Hospital
Enrollment
60
Locations
1
Primary Endpoint
Sleep quality
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 17, 2019
End Date
July 27, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wan-Ju Cheng

Physician

China Medical University Hospital

Eligibility Criteria

Inclusion Criteria

  • Shift work disorder

Exclusion Criteria

  • Neuromuscular disorder
  • Taking hypnotics
  • Pregnancy

Outcomes

Primary Outcomes

Sleep quality

Time Frame: Change from baseline score at the second and third week.

Pittsburgh sleep quality index (PSQI), range from 0 (better) to 21 (worse)

Secondary Outcomes

  • Daytime sleepiness(Change from baseline score at the start and end of each night shift.)
  • Alertness(Change from baseline score at the start and end of each night shift.)

Study Sites (1)

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