Sleep Schedule Intervention Study Among Night Shift Workers

Shift Work Schedule Clinical Trial

Official title:

Sleep Schedule Intervention Study Among Night Shift Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160572
• Other study ID #: CMUH108-REC3-097
• Status: Completed
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: July 27, 2021

Study information

• Verified date: July 2021
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 27, 2021
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Shift work disorder

Exclusion Criteria:

• Neuromuscular disorder

• Taking hypnotics

• Pregnancy

Related Conditions & MeSH terms

• Shift Work Schedule

Intervention

Behavioral:
• Morning sleep schedule
sleep right after night shifts
• Evening sleep schedule
sleep before night shifts

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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