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Completed

NCT Number: NCT04160572

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.

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Key information

Conditions

Shift Work Schedule

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 404332, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Shift work disorder

Exclusion criteria

  • Neuromuscular disorder
  • Taking hypnotics
  • Pregnancy

Treatment and study plan

Morning sleep schedule

Behavioral

sleep right after night shifts

Evening sleep schedule

Behavioral

sleep before night shifts

Primary outcomes

  1. 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

  1. Daytime sleepiness

    Time frame: Change from baseline score at the start and end of each night shift.

    Karolinska Sleepiness Scale (KSS), range from 1 (better) to 9 (worse)

  2. Alertness

    Time frame: Change from baseline score at the start and end of each night shift.

    Psychomotor vigilance test (PVT), reaction time (longer the worse) and lapses (larger the worse)

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 13, 2019
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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