Sleep Schedule Intervention Study Among Night Shift Workers
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedStudy Start
First participant enrolled
December 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2021
CompletedJuly 30, 2021
July 1, 2021
1 year
November 8, 2019
July 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep quality
Pittsburgh sleep quality index (PSQI), range from 0 (better) to 21 (worse)
Change from baseline score at the second and third week.
Secondary Outcomes (2)
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 Arms (2)
Morning-evening sleep schedule
EXPERIMENTALEvening-morning sleep schedule
ACTIVE COMPARATORInterventions
sleep right after night shifts
sleep before night shifts
Eligibility Criteria
You may qualify if:
- Shift work disorder
You may not qualify if:
- Neuromuscular disorder
- Taking hypnotics
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 404332, Taiwan
Related Publications (1)
Cheng WJ, Hang LW, Kubo T, Vanttola P, Huang SC. Impact of sleep timing on attention, sleepiness, and sleep quality among real-life night shift workers with shift work disorder: a cross-over clinical trial. Sleep. 2022 Apr 11;45(4):zsac034. doi: 10.1093/sleep/zsac034.
PMID: 35148396DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
November 8, 2019
First Posted
November 13, 2019
Study Start
December 17, 2019
Primary Completion
December 23, 2020
Study Completion
July 27, 2021
Last Updated
July 30, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share