Light Intervention for Adaptation to Night Work

May 15, 2019 updated by: University of Bergen

Effects of Bright Light Intervention for Adaptation to Night Work: Shift Work Simulation Experiments

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.

Study Overview

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

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hordaland
      • Bergen, Hordaland, Norway, 5020
        • The faculty of psychology, University of Bergen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.
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.
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.
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.
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.
EXPERIMENTAL: Blue light, 455 nm
Participants work one night shift with blue LED-light (peak wavelength 455 nm) administered through standard room lighting.
Blue light with peak wavelength 455 nm. Known to delay the circadian rhythm, suppress melatonin, and increase alertness.
ACTIVE_COMPARATOR: Red light, 615 nm
Participants work one night shift with red LED-light (peak wavelength 615 nm) administered through standard room lighting.
Red light with peak wavelength 615 nm. Known not to affect the circadian rhythm, melatonin, and alertness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 nights
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.
5 days-nights
Sleep
Time Frame: 9 days-nights
Sleep will be measured objectively using actigraphy
9 days-nights

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
3 nights
Self-reported sleep
Time Frame: 9 days-nights
A sleep diary will be used.
9 days-nights
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.
3 nights
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)
3 nights
Granulocyte macrophage colony-stimulating factor (GM-CSF)
Time Frame: 3 nights
Blood-spot samples will be analyzed for GM-CSF.
3 nights
Interferon gamma (IFN-gamma)
Time Frame: 3 nights
Blood-spot samples will be analyzed for IFN-gamma.
3 nights
Tumor necrosis factor alpha (TNF-a)
Time Frame: 3 nights
Blood-spot samples will be analyzed for TNF-a
3 nights
Positive and negative affect
Time Frame: 3 nights
'Positive and Negative Affect Schedule', will be administered to assess mood.
3 nights
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.
3 nights
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.
3 nights
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)

3 nights
Working memory
Time Frame: 3 nights
A 'Working Memory Scanning Task' measure ability to encode and maintain information in working memory
3 nights
Decision/ response execution
Time Frame: 3 nights
A 'Two-Choice Numerosity Discrimination Task' measure decision criterion and response execution
3 nights
Decision/ response inhibition
Time Frame: 3 nights
A 'Reversal Learning Decision Task' measure ability to adjust choices/ response inhibition
3 nights
Cognitive control
Time Frame: 3 nights
A 'Task Switching-Performance Test' measure cognitive control
3 nights
Planning
Time Frame: 3 nights
The 'Tower of Hanoi Test' measure planning and sequencing abilities
3 nights
Moral reasoning
Time Frame: 3 nights
the 'Defining Issues Test' measure moral reasoning.
3 nights
Cognitive throughput
Time Frame: 3 nights
A 'Digit Symbol Substitution Test' will be used as a measure of cognitive throughput
3 nights
Fine motor skills
Time Frame: 3 nights
The 'grooved pegboard test' assess fine motor skills through the night shifts
3 nights
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.
3 nights
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.
3 nights
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.
1-2 nights
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.
2 nights, 1 day
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).
3 nights
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.
3 nights and sleep periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Erlend Sunde, University of Bergen, Department of Psychosocial Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 25, 2017

Primary Completion (ACTUAL)

March 27, 2019

Study Completion (ACTUAL)

March 27, 2019

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (ACTUAL)

June 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the project has ended the data will be anonymized and no direct recognizable information will be stored.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep

Clinical Trials on LED-light, 1000 lux

3
Subscribe