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Light Treatment to Shift-working Nurses

Primary Purpose

Shift-Work Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Bright light
Red light
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shift-Work Sleep Disorder focused on measuring Bright light, Sleepiness, Sleep, Psychomotor vigilance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Bergen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bright light

Red light

Arm Description

10 000 lux

400 lux

Outcomes

Primary Outcome Measures

Sleepiness during the night shifts
Self-reported using the Karolinska Sleepiness Scale (KSS)

Secondary Outcome Measures

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

Full Information

First Posted
November 25, 2016
Last Updated
October 1, 2019
Sponsor
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT02978053
Brief Title
Light Treatment to Shift-working Nurses
Official Title
The Effects of Bright Light on Adaptation to Night Work Among Nurses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift-Work Sleep Disorder
Keywords
Bright light, Sleepiness, Sleep, Psychomotor vigilance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright light
Arm Type
Experimental
Arm Description
10 000 lux
Arm Title
Red light
Arm Type
Placebo Comparator
Arm Description
400 lux
Intervention Type
Behavioral
Intervention Name(s)
Bright light
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Red light
Intervention Description
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).
Primary Outcome Measure Information:
Title
Sleepiness during the night shifts
Description
Self-reported using the Karolinska Sleepiness Scale (KSS)
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Psychomotor vigilance during night shifts
Description
Objective data from a 5 min computer based psychomotor vigilance test (PC-PVT) taken once during each night shift
Time Frame
3 days
Title
Sleep after the night shifts
Description
Self-reported using a sleep diary; objective data from actigraphs
Time Frame
3 days
Title
Sleepiness during the days after the night shift period
Description
Self-reported using the Karolinska Sleepiness Scale (KSS)
Time Frame
3 days
Title
Sleep during the days after the night shift period
Description
Self-reported using a sleep diary; objective data from actigraphs
Time Frame
3 days
Title
Functioning on each shift, and shift period in total, compared to under normal conditions
Description
Self-reported perception of effect of intervention
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Bjorvatn, MD, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bergen
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5018
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Light Treatment to Shift-working Nurses

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