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Light Intervention for Adaptation to Night Work

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ClinicalTrials.gov Identifier: NCT03203538
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Glamox
Information provided by (Responsible Party):
University of Bergen

Tracking Information
First Submitted Date  ICMJE May 3, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE August 25, 2017
Actual Primary Completion Date March 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • Cognitive performance [ Time Frame: 3 nights ]
    Cognitive performance will be measured using the Psychomotor Vigilance Test (PVT). The PVT measures sustained attention, and is considered the 'gold standard' for assessing the effects of sleep deprivation on cognition. The task will be performed approx. every 1.5h throughout the nightshifts.
  • Circadian phase [ Time Frame: 5 days-nights ]
    Circadian phase will be measured through assessement of 'Dim Light Melatonin Onset' (DLMO). Saliva samples will be collected every hour in the evening (from 7 pm) to one hour past regular bedtime, one day before the first night shift and the day after the night shift period. Saliva will be analyzed for melatonin, giving an estimate on DLMO.
  • Sleep [ Time Frame: 9 days-nights ]
    Sleep will be measured objectively using actigraphy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • Subjective sleepiness [ Time Frame: 3 nights ]
    Karolinska Sleepiness Scale (KSS) will be used to assess subjective sleepiness throughout the night shifts. KSS is a likert scale ranging from 1-9, where subjects rate their sleepiness. '1' indicates 'extremely alert', '9' indicates 'very sleepy/fighting sleep'.
  • Self-reported sleep [ Time Frame: 9 days-nights ]
    A sleep diary will be used.
  • Heart rate variability [ Time Frame: 3 nights ]
    'Heart Rate Variability' will be assessed by using Polar heart rate monitor V800 that will continuously monitor 'HRV' through the night.
  • Interleukin [ Time Frame: 3 nights ]
    Blood spot samples will be analyzed for interleukins (IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-13)
  • Granulocyte macrophage colony-stimulating factor (GM-CSF) [ Time Frame: 3 nights ]
    Blood-spot samples will be analyzed for GM-CSF.
  • Interferon gamma (IFN-gamma) [ Time Frame: 3 nights ]
    Blood-spot samples will be analyzed for IFN-gamma.
  • Tumor necrosis factor alpha (TNF-a) [ Time Frame: 3 nights ]
    Blood-spot samples will be analyzed for TNF-a
  • Positive and negative affect [ Time Frame: 3 nights ]
    'Positive and Negative Affect Schedule', will be administered to assess mood.
  • Pain sensitivity [ Time Frame: 3 nights ]
    By using a handheld pressure algometer, Wagner FPIX Force One, the pressure pain threshold will be measured. The test site will be the trapezius muscle, and the pressure will be increased in steps of 5 N/sec until the participant indicates pain.
  • Headache and eyestrain [ Time Frame: 3 nights ]
    A 'Headache and Eyestrain Scale' will be used to get subjective measures on how participants perceive the lighting conditions.
  • Appetite/ food cravings [ Time Frame: 3 nights ]
    Appetite/ food cravings for different food types will be assessed using a visual analogue scale to record response to questions like: "How much would you like to eat xxx right now?" A 'Dot-probe test' provides measure of attentional bias towards various food types (pictures)
  • Working memory [ Time Frame: 3 nights ]
    A 'Working Memory Scanning Task' measure ability to encode and maintain information in working memory
  • Decision/ response execution [ Time Frame: 3 nights ]
    A 'Two-Choice Numerosity Discrimination Task' measure decision criterion and response execution
  • Decision/ response inhibition [ Time Frame: 3 nights ]
    A 'Reversal Learning Decision Task' measure ability to adjust choices/ response inhibition
  • Cognitive control [ Time Frame: 3 nights ]
    A 'Task Switching-Performance Test' measure cognitive control
  • Planning [ Time Frame: 3 nights ]
    The 'Tower of Hanoi Test' measure planning and sequencing abilities
  • Moral reasoning [ Time Frame: 3 nights ]
    the 'Defining Issues Test' measure moral reasoning.
  • Cognitive throughput [ Time Frame: 3 nights ]
    A 'Digit Symbol Substitution Test' will be used as a measure of cognitive throughput
  • Fine motor skills [ Time Frame: 3 nights ]
    The 'grooved pegboard test' assess fine motor skills through the night shifts
  • Recognition of emotions [ Time Frame: 3 nights ]
    An 'emotional hexagon test', were participants rate standardized pictures of faces expressing different emotions, measure the ability to discriminate between emotional expressions.
  • Pupil size [ Time Frame: 3 nights ]
    Pupil size will be measured, using a tobii eyetracker, three times during night shifts. This can provide an objective measure of sleepiness.
  • Core body temperature [ Time Frame: 1-2 nights ]
    To get a secondary measure of circadian phase, core body temperature will be measured using ingestible temperature capsules.
  • Leadership evaluation [ Time Frame: 2 nights, 1 day ]
    The 'Multifactor Leadership Questionnaire' will be used to assess participants leadership preferences. The questionnaire will be administered during daytime and during night shifts.
  • Experiences of perceptual anomalies [ Time Frame: 3 nights ]
    The Cardiff Anomalous Perceptions Scale (CAPS) questionnaire will be administered after the night shifts to assess experiences of hallucinations and perceptual anomalies during night shifts. The questionnaire consists of 32 items/questions regarding perceptual anomalies, e.g. "Do you ever notice that sounds are much louder than they normally would be?", that are answered with 'yes' or 'no'. Adding up the number of 'yes' answers gives the CAPS Total Score ranging from 0 (low) to 32 (high). For each item endorsed, participants rate the item for distress, intrusiveness and frequency, giving three subscales. The rating for subscales goes from 1 (low) to 5 (high). Nonendorsed items are considered to have a score of 0 on subscales. For each subscale the possible range goes from 0 (low) to 160 (high).
  • Objective sleepiness, sleep and sleep stages [ Time Frame: 3 nights and sleep periods ]
    A subgroup of participants (12-16 in each experiment) will be subject to electroencephalography (EEG) during night shifts, and polysomnography (PSG) after night shifts. EEG will provide a measure of electrical activity in the brain during wakefulness, and can provide an objective measure of sleepiness. PSG will be conducted in the sleep period after night shifts, and allow for the scoring of sleep stages. PSG is considered the gold standard for measuring sleep.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • Self-reported sleep [ Time Frame: 9 days-nights ]
    A sleep diary will be used.
  • Heart rate variability [ Time Frame: 3 nights ]
    'Heart Rate Variability' will be assessed by using Polar heart rate monitor V800 that will continuously monitor 'HRV' through the night.
  • Interleukin [ Time Frame: 3 nights ]
    Blood spot samples will be analyzed for interleukins (IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-13)
  • Granulocyte macrophage colony-stimulating factor (GM-CSF) [ Time Frame: 3 nights ]
    Blood-spot samples will be analyzed for GM-CSF.
  • Interferon gamma (IFN-gamma) [ Time Frame: 3 nights ]
    Blood-spot samples will be analyzed for IFN-gamma.
  • Tumor necrosis factor alpha (TNF-a) [ Time Frame: 3 nights ]
    Blood-spot samples will be analyzed for TNF-a
  • Positive and negative affect [ Time Frame: 3 nights ]
    'Positive and Negative Affect Schedule', will be administered to assess mood.
  • Pain sensitivity [ Time Frame: 3 nights ]
    By using a handheld pressure algometer, Wagner FPIX Force One, the pressure pain threshold will be measured. The test site will be the trapezius muscle, and the pressure will be increased in steps of 5 N/sec until the participant indicates pain.
  • Headache and eyestrain [ Time Frame: 3 nights ]
    A 'Headache and Eyestrain Scale' will be used to get subjective measures on how participants perceive the lighting conditions.
  • Appetite/ food cravings [ Time Frame: 3 nights ]
    Appetite/ food cravings for different food types will be assessed using a visual analogue scale to record response to questions like: "How much would you like to eat xxx right now?" A 'Dot-probe test' provides measure of attentional bias towards various food types (pictures)
  • Working memory [ Time Frame: 3 nights ]
    A 'Working Memory Scanning Task' measure ability to encode and maintain information in working memory
  • Decision/ response execution [ Time Frame: 3 nights ]
    A 'Two-Choice Numerosity Discrimination Task' measure decision criterion and response execution
  • Decision/ response inhibition [ Time Frame: 3 nights ]
    A 'Reversal Learning Decision Task' measure ability to adjust choices/ response inhibition
  • Decision/ risk-taking [ Time Frame: 3 nights ]
    The 'Iowa Gambling Task' measure risk-taking and decision making
  • Cognitive control [ Time Frame: 3 nights ]
    A 'Task Switching-Performance Test' measure cognitive control
  • Planning [ Time Frame: 3 nights ]
    The 'Tower of London Test' measure planning and sequencing abilities
  • Moral reasoning [ Time Frame: 3 nights ]
    the 'Defining Issues Test' measure moral reasoning.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Light Intervention for Adaptation to Night Work
Official Title  ICMJE Effects of Bright Light Intervention for Adaptation to Night Work: Shift Work Simulation Experiments
Brief Summary The project will contribute with new knowledge concerning how aspects of the physical work environment (lighting conditions) can be arranged to facilitate the workers' adaptation to night work. This is important given the reported adverse consequences of shift work for performance, safety, and health. The project involves a series of three experimental, laboratory based shift work simulation studies. The aim is to investigate how different lighting conditions (intensities and colour temperature), administered through light emitting diode (LED) based bright light integrated standard room lighting, affects adaptation to three consecutive simulated night shifts and re adaptation to a day oriented schedule on measures of alertness, cognitive performance, sleep and circadian rhythm. The proposed project examines the effects of interventions that can be applied in naturalistic settings and will be based on new laboratory infrastructure available at the laboratories situated in the Faculty of Psychology, University of Bergen.
Detailed Description

Bright light has been suggested as a countermeasure to the negative impact of night work in terms of safety, performance and subsequent sleep. The effect depends on the timing of light (e.g, phase-response curve), duration of light exposure and the intensity of light, as well as the wavelengths that are emitted. Exposure to bright light (more intense than typical room lightning), at evening and night, has been effective in delaying the circadian rhythm to sufficiently adapt to night work both in simulated night work, and in field studies of workers. Blue light has significantly stronger phase shifting effects than other wavelengths of the visible spectrum. The effect of light on the circadian system is mediated by retinal photoresponsive cell population (intrinsically photoresponsive retinal ganglion cells; ipRGC) that contains the photopigment melanopsin, highly sensitive to blue light. These cells signal directly to the suprachiasmatic nuclei (SCN) of the hypothalamus, the circadian pacemaker. Bright light has also been reported to improve alertness and performance during night shifts.

To the best of the investigators knowledge, no shift work simulation study has made the full advance of LED-technology in terms of using light administered via standard room lighting on adaptation to night work. Today, new LED-technology represents an excellent opportunity to study this as roof mounted LED-sources integrated as standard indoor lightening can be programmed to provide a wide range of light intensities and colour temperatures. LED-sources have the advantage over standard light therapy that subjects can be exposed to the therapy via standard room lightening (not confined to a special therapy lamp) thereby allowing the workers to conduct work tasks as normal during light exposure.

Against this backdrop this project aims to investigate how different lighting conditions, administered through LED-based bright light integrated standard room lighting, affects adaptation to three consecutive simulated night shifts and re adaptation to a day oriented schedule on measures of alertness, cognitive performance, sleep and circadian rhythm. In addition, measures of mood, appetite, heart rate variability (HRV), pain sensitivity, moral reasoning, and inflammatory markers will be examined. The researchers also aim to investigate the effects of two extreme monochromatic light conditions (blue vs. red) based on integrated standard room lighting on the adaptation to one simulated night shift.

Study participants will work simulated night shifts (11:00 pm to 07:00 am) in a light laboratory where light parameters (intensity and colour temperature) can be manipulated via roof mounted LED-sources integrated as standard indoor lightening. Participants will be recruited among students at the University of Bergen, and a screening will be done to ensure healthy participants fit for the study. The included participants will take part in experiments with two bouts of three consecutive simulated night shifts (6 nights in total).

HRV will be measured throughout the night shift, and five times, approx. every 1.5 hour (11:30 pm, 01:00 am, 02:30 am, 04:00 am, 05:30 am), the subjects will be tested on a test battery of cognitive tests and will rate their subjective sleepiness. Sleep will be assessed by sleep diary and actigraphy 3 days prior to, during, and 3 days following the shifts. One day before the night shift and the day after the night shift period the circadian rhythm will be measured by saliva samples for estimation of dim light melatonin onset. Prior to-, during- and after the night shifts, participants will undergo a pain sensitivity test. Blood spot samples will be collected at the beginning and the end of each night shift for analysis of inflammatory markers (e.g. interleukins).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Three related night shift studies have been planned. Each study investigates how different lighting conditions, administered through LED-based bright light integrated standard room lighting, affects adaptation to simulated night shifts and re adaptation to a day oriented schedule.

In each study, 28 participants (84 in total) will be exposed to the interventions (light conditions) in a randomized, blinded, controlled, crossover study.

The simulated night shifts will last from 11pm to 7am. The specific light conditions will last from 11pm to 5am (study 1: 1000 lux vs. 100 lux; study 2: 7000 K vs. 2500 K; study 3: 455 nm vs. 615 nm) where after (from 5am to 7am) all participants will be exposed to the same light conditions (200 lux, 4000 K). After completion of one bout of night work (three consecutive shifts for study 1 and 2; one night shift for study 3) there will be a washout period of four weeks before the participants cross over.

Masking: Single (Participant)
Masking Description:
Participants will not be given information on the hypotheses/ expected effects from the different interventions (light conditions).
Primary Purpose: Supportive Care
Condition  ICMJE
  • Shift-Work Related Sleep Disturbance
  • Sleep Deprivation
  • Sleep
Intervention  ICMJE
  • Device: LED-light, 1000 lux
    Full-spectrum light, 1000 lux, 4000 K. Represent a light intensity within acceptable range (light that is not too glary); 4000 K is among the most commonly used indoor light colour temperatures.
  • Device: LED-light, 100 lux
    Full-spectrum light, 100 lux, 4000 K. Represent a light intensity within acceptable range (light that provides sufficient eye sight); 4000 K is among the most commonly used indoor light colour temperatures.
  • Device: LED-light, 7000 K
    Full-spectrum light, 7000 K, 200 lux. Represent the upper border of common colour indoor light temperature, 200 lux is a common indoor light intensity.
  • Device: LED-light, 2500 K
    Full-spectrum light, 2500 K, 200 lux. Represent the lower border of common colour indoor light temperature, 200 lux is a common indoor light intensity.
  • Device: Blue LED-light
    Blue light with peak wavelength 455 nm. Known to delay the circadian rhythm, suppress melatonin, and increase alertness.
  • Device: Red LED-light
    Red light with peak wavelength 615 nm. Known not to affect the circadian rhythm, melatonin, and alertness.
Study Arms  ICMJE
  • Experimental: Light intensity, 1000 lux (4000 K)
    Participants will work three consecutive simulated night shifts under full-spectrum LED-light, 1000 lux (4000 Kelvin) administered through standard room lighting.
    Intervention: Device: LED-light, 1000 lux
  • Active Comparator: Light intensity, 100 lux (4000 K)
    Participants will work three consecutive simulated night shifts under full-spectrum LED-light, 100 lux (4000 Kelvin) administered through standard room lighting.
    Intervention: Device: LED-light, 100 lux
  • Experimental: Colour temperature, 7000 Kelvin
    Participants will work three consecutive simulated night shifts under full-spectrum LED-light, 7000 K (200 lux) administered through standard room lighting.
    Intervention: Device: LED-light, 7000 K
  • Active Comparator: Colour temperature, 2500 Kelvin
    Participants will work three consecutive simulated night shifts under full-spectrum LED-light, 2500 K (200 lux) administered through standard room lighting.
    Intervention: Device: LED-light, 2500 K
  • Experimental: Blue light, 455 nm
    Participants work one night shift with blue LED-light (peak wavelength 455 nm) administered through standard room lighting.
    Intervention: Device: Blue LED-light
  • Active Comparator: Red light, 615 nm
    Participants work one night shift with red LED-light (peak wavelength 615 nm) administered through standard room lighting.
    Intervention: Device: Red LED-light
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2019)
97
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2017)
102
Actual Study Completion Date  ICMJE March 27, 2019
Actual Primary Completion Date March 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants are physical and mentally healthy (assessed with BMI and 'General Health Questionnaire-12')
  • Participants accept to comply with the protocol (refrain from alcohol, tobacco and coffee, and retain regular bed- and wake-times the week before the simulated night shifts)

Exclusion Criteria:

  • Neurological, psychiatric or sleep related disorders ('Bergen Insomnia Scale', 'global sleep assessement questionnaire')
  • Extreme 'morningness-eveningness' type ('Horne Östberg morningness eveningness questionnaire')
  • Use of medication
  • Worked night shifts the last 3 months
  • Travelled through more than two time zones the last 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03203538
Other Study ID Numbers  ICMJE 270755
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: After the project has ended the data will be anonymized and no direct recognizable information will be stored.
Current Responsible Party University of Bergen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Bergen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Glamox
Investigators  ICMJE
Principal Investigator: Erlend Sunde University of Bergen, department of psychosocial science
PRS Account University of Bergen
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP