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Trial record 1 of 1 for:    NCT 02978053
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Light Treatment to Shift-working Nurses

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ClinicalTrials.gov Identifier: NCT02978053
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Bjorn Bjorvatn, University of Bergen

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.

Condition or disease Intervention/treatment Phase
Shift-Work Sleep Disorder Behavioral: Bright light Behavioral: Red light Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Bright Light on Adaptation to Night Work Among Nurses
Actual Study Start Date : November 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Bright light
10 000 lux
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).

Placebo Comparator: Red light
400 lux
Behavioral: 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).




Primary Outcome Measures :
  1. Sleepiness during the night shifts [ Time Frame: 3 days ]
    Self-reported using the Karolinska Sleepiness Scale (KSS)


Secondary Outcome Measures :
  1. Psychomotor vigilance during night shifts [ Time Frame: 3 days ]
    Objective data from a 5 min computer based psychomotor vigilance test (PC-PVT) taken once during each night shift

  2. Sleep after the night shifts [ Time Frame: 3 days ]
    Self-reported using a sleep diary; objective data from actigraphs

  3. Sleepiness during the days after the night shift period [ Time Frame: 3 days ]
    Self-reported using the Karolinska Sleepiness Scale (KSS)

  4. Sleep during the days after the night shift period [ Time Frame: 3 days ]
    Self-reported using a sleep diary; objective data from actigraphs

  5. Functioning on each shift, and shift period in total, compared to under normal conditions [ Time Frame: 6 days ]
    Self-reported perception of effect of intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978053


Locations
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Norway
University of Bergen
Bergen, Hordaland, Norway, 5018
Sponsors and Collaborators
University of Bergen
Investigators
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Principal Investigator: Bjørn Bjorvatn, MD, PhD University of Bergen
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Responsible Party: Bjorn Bjorvatn, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT02978053    
Other Study ID Numbers: UiB112016
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bjorn Bjorvatn, University of Bergen:
Bright light
Sleepiness
Sleep
Psychomotor vigilance
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases