Sleep Schedule Intervention Study Among Night Shift Workers

NCT ID: NCT04160572

Last Updated: 2021-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-17

Study Completion Date

2021-07-27

Brief Summary

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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

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Conditions

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Shift Work Schedule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Morning-evening sleep schedule

Group Type EXPERIMENTAL

Morning sleep schedule

Intervention Type BEHAVIORAL

sleep right after night shifts

Evening sleep schedule

Intervention Type BEHAVIORAL

sleep before night shifts

Evening-morning sleep schedule

Group Type ACTIVE_COMPARATOR

Morning sleep schedule

Intervention Type BEHAVIORAL

sleep right after night shifts

Evening sleep schedule

Intervention Type BEHAVIORAL

sleep before night shifts

Interventions

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Morning sleep schedule

sleep right after night shifts

Intervention Type BEHAVIORAL

Evening sleep schedule

sleep before night shifts

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Shift work disorder

Exclusion Criteria

* Neuromuscular disorder
* Taking hypnotics
* Pregnancy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wan-Ju Cheng

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 35148396 (View on PubMed)

Other Identifiers

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CMUH108-REC3-097

Identifier Type: -

Identifier Source: org_study_id

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