Sleep Schedule Intervention Study Among Night Shift Workers

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.

Study Overview

• Status: Completed
• Conditions: Shift Work Schedule
• Intervention / Treatment: Behavioral: Morning sleep schedule; Behavioral: Evening sleep schedule

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City, Taiwan, 404332
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Shift work disorder

Exclusion Criteria:

• Neuromuscular disorder
• Taking hypnotics
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Morning-evening sleep schedule	Behavioral: Morning sleep schedule; sleep right after night shifts; Behavioral: Evening sleep schedule; sleep before night shifts
ACTIVE_COMPARATOR: Evening-morning sleep schedule	Behavioral: Morning sleep schedule; sleep right after night shifts; Behavioral: Evening sleep schedule; sleep before night shifts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2019
• Primary Completion (ACTUAL): December 23, 2020
• Study Completion (ACTUAL): July 27, 2021

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 9, 2019
• First Posted (ACTUAL): November 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CMUH108-REC3-097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No