The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms

NCT03758768 | Completed DMC

• 1 other identifier: 271561
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The present project is aimed to contribute with new knowledge concerning how light conditions in the physical environment can be manipulated to alter the sleep and circadian rhythms of individuals with an evening-type circadian rhythm. More precisely, the study will explore whether exposure to blue light (compared to a full spectrum light control condition) during the morning hours advance the circadian rhythms of evening-type individuals, towards that which is more similar to the daily rhythm of morning-type individuals. This study is important as it has been found that evening-type adolescents and adults are at higher risk of poor academic performance and demonstrate lower intellectual performance when tested at their nonoptimal early times of day, and given the fact that most schools and workplaces structure their working hours during such early hours of the day. Such an intervention could thus help evening-type individuals better adjust to the different early day requirements that they are exposed to. The project involves a three-day intervention where participants will be exposed to blue monochromatic light, administered through ceiling mounted light emitting diode (LED)-based room lighting, in the early hours of each morning for a duration of 60 min. The participants' sleep, circadian rhythm and waking function will be assessed both objectively and subjectively. The effects of the intervention are transferable to real life educational and work settings and can thus be applied in naturalistic settings. The intervention is based on the new laboratory infrastructure available at the sleep laboratory situated in Christies gate 12.

Conditions

Circadian Rhythm Sleep Disorder, Delayed Sleep Phase; Sleep

Keywords

Circadian rhythm; Sleep; evening-type individuals; morningness-eveningness; blue light; monochromatic light; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• Change scores from baseline to post-intervention in Dim light melatonin onset (DLMO)

  Melatonin either in plasma, saliva or urine is regarded as an objective marker of circadian rhythms, of which the dim light melatonin onset (time when melatonin reaches 4 pg/ml in saliva) is the most commonly used parameter (Pandi-Perumal et al., 2007). The change score of the intervention group will be compared to the change score of the control group. Thus only one parameter will be estimated.

  Pre-intervention/baseline (Monday in the week of intervention - one day before the first intervention day); Post-intervention (Friday, the week of intervention - one day after last intervention day)

• Change scores of Feeling of Morning Wakefulness, measured by Sleep Diary

  Change scores of the feeling of morning wakefulness across Tuesday to Thursday the week before intervention, substracted from Feeling of Morning Wakefulness across Tuesday to Thursday on the intervention week. Since the comparison is made across days/measurement points, only one composite parameter for each condition will be calculated.

  Tuesday, Wednesday and Thursday (baseline; week before intervention); Tuesday, Wednesday and Thursday (week of light intervention)

• Psychomotor Vigilance Task (PVT)

  A 10-minute reaction-time test that provides a measure of sustained attention will be completed by the participants during light exposure in the laboratory. The participant simply responds to stimuli given on a display by pressing a button as soon as possible. PVT is especially sensitive to sleep loss and fatigue (Lamond, Dawson \& Roach, 2005). Average scores of reaction time across Tuesday, Wednesday and Thursday (the three days of light intervention) will be calculated for the intervention group and compared to the average scores of reaction time across Tuesday, Wednesday and Thursday (the three days of light intervention for the control group. Since the comparison is made across days/measurement points, only one composite parameter for each condition will be calculated.

  PVT will be given to participants on the three days of light intervention (Tuesday, Wednesday and Thursday). The average score of these three days will be obtained and compared with the control group.

• Karolinska Sleepiness Scale (KSS)

  KSS comprises a single item assessing state sleepiness on a scale from 1 (very rested) to 9 (very sleepy). (Aakerstedt \& Gillberg, 1990). The minimum score is 1 (very rested) and the maximum is 9 (very sleepy). Lower values present the feeling of restedness and are thus considered to be a better outcome. Average score of KSS will be calculated across the three intervention days (Tuesday, Wednesday, Thursday) for the intervention group, and compared to the average score of KSS across the same three intervention days for the control group. Accordingly, only one outcome measure will be calculated per group. Thus only one parameter will be estimated.

  Given on the days of intervention (Tuesday, Wednesday, Thursday) twice on each day. First immediately when the participants enter the lab to receive the intervention, and the second after they have received one hour of light, before they leave the lab.

Secondary Outcomes (3)

• Changes scores in Sleep Length

  Change scores of sleep length across Tuesday, Wednesday and Thursday the week before intervention, substracted from sleep length across Tuesday, Wednesday and Thursday on the intervention week.

• Change scores in Sleep Onset Time

  Change scores of sleep onset time across Tuesday, Wednesday, and Thursday the week before intervention, substracted from sleep onset time across Tuesday, Wednesday, and Thursday on the intervention week.

• Changes scores in Wake-up Time

  Change scores of wake-up time across Tuesday, Wednesday and Thursday the week before intervention, substracted from wake-up time across Tuesday, Wednesday and Thursday on the intervention week.

Study Arms (2)

Blue monochromatic light

EXPERIMENTAL

Three consecutive mornings of one hour exposure to monochromatic light (20 lx, irradiance = 49.65 µW/cm2) with peak wavelength of 455 nm (blue light), with equal photon flux as the control condition.

Other: Blue light exposure

Full spectrum light control condition

ACTIVE COMPARATOR

Three consecutive mornings of one hour exposure to full spectrum light (2500 Kelvin, irradiance = 37.72 µW/cm2) with equal photon flux as the blue light. We will adjust the light intensity to make sure that the photon energy is the same across the two conditions.

Other: Full spectrum light exposure

Interventions

Blue light exposure OTHER

Light administered through ceiling mounted light emitting diode (LED)-based room lighting.

Blue monochromatic light

Full spectrum light exposure OTHER

Light administered through ceiling mounted light emitting diode (LED)-based room lighting.

Full spectrum light control condition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Scoring below 42 on the Horne-Östberg Morningness-Eveningness Questionnaire, as this categorizes moderate and definitely evening types (Horne \& Östberg, 1976).

You may not qualify if:

• Participants will be excluded if a positive case is indicated on the Mood Disorder Questionnaire (MDQ), indicating the presence or history of bipolar disorder.
• Participants will also be excluded if they have worked night shifts during the past three months.

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5015, Norway

Location

Related Publications (31)

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MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Ståle Pallesen

  The University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A third-party investigator is recruited to be present during the intervention. This third-party investigator has no knowledge of the hypotheses of the study. Although the participants can see the type of light they receive, they have no knowledge of the study hypotheses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, single-blinded trial.

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 29, 2018
• Study Start: September 25, 2018
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

NO (1)