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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02978053
Other study ID # UiB112016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date June 2019

Study information

Verified date October 2019
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project examines 1) the effects of appropriately timed bright light on adaptation (in terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule after the night shift period.


Description:

Shift workers frequently experience sleepiness during night shifts, which may have consequences for performance. Sleep duration is often shortened after a night shift. Properly timed bright light treatment is efficient in delaying the circadian rhythm and can enhance alertness, increase performance and prolong sleep after night shifts. There is a lack of studies on light treatment to rotating shift workers. This study is a randomized controlled crossover trial evaluating the effect of bright light treatment on sleep and sleepiness in rotating shift workers with three consecutive night shifts. The aim is to evaluate whether bright light treatment improves adaptation to three consecutive night shifts (reduces sleepiness during night shifts and improves sleep after night shifts), as well as whether such treatment affects re-adaptation to a day-oriented schedule after the night shift period.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- A rotating shift work schedule involving three days without night shifts, followed by three consecutive night shifts, followed by three days without night shifts

- Problems with sleepiness during night shifts

Exclusion Criteria:

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Bright light
Bright light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).
Red light
Red light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).

Locations

Country Name City State
Norway University of Bergen Bergen Hordaland

Sponsors (1)

Lead Sponsor Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleepiness during the night shifts Self-reported using the Karolinska Sleepiness Scale (KSS) 3 days
Secondary Psychomotor vigilance during night shifts Objective data from a 5 min computer based psychomotor vigilance test (PC-PVT) taken once during each night shift 3 days
Secondary Sleep after the night shifts Self-reported using a sleep diary; objective data from actigraphs 3 days
Secondary Sleepiness during the days after the night shift period Self-reported using the Karolinska Sleepiness Scale (KSS) 3 days
Secondary Sleep during the days after the night shift period Self-reported using a sleep diary; objective data from actigraphs 3 days
Secondary Functioning on each shift, and shift period in total, compared to under normal conditions Self-reported perception of effect of intervention 6 days
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