Circadian Rhythm Sleep Disorder, Delayed Sleep PhaseNCT03758768
The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms
A study testing Blue light exposure and Full spectrum light exposure in people with Circadian Rhythm Sleep Disorder, Delayed Sleep Phase and Sleep, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm Sleep Disorder, Delayed Sleep Phase, Sleep
- What is being tested?
- Blue light exposure and Full spectrum light exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNorway
- Study dates
- 25 Sep 2018to 22 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Scoring below 42 on the Horne-Östberg Morningness-Eveningness Questionnaire, as this categorizes moderate and definitely evening types (Horne \& Östberg, 1976).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background:
Morningness/eveningness is a phenomenon that reflects the tendency to be an "early morning bird" or a "late night owl" and is thus a source of inter-individual variation in timing of sleep and other behaviors. Evening- and morning-type individuals demonstrate differences that derive internally regarding the circadian phase of their endogenous biological clock. A certain group of individuals referred to as morning-type individuals have been consistently found to perform better in the morning, whereas evening-type individuals appear to be more alert and perform better in the evening. Morning-type individuals have earlier bed- and rise times than evening-types, while evening-type individuals have been known to report significantly later bed- and rise-times compared to morning-type individuals. In addition, evening-type adolescents have been known to demonstrate poorer academic and intellectual performances during their nonpreferred, i.e., early hours of the day.
Circadian rhythms are known as biological processes that display endogenous, entrainable oscillations in a period of about 24 hours. These rhythms have been found to be controlled by the circadian pacemaker, which is located in the suprachiasmatic nuclei (SCN) of the hypothalamus. These 24-hour rhythms manifest themselves in an observable manner within numerous physiological measures, such as the sleep-wake cycle, the core body temperature, and the excretion of hormones such as melatonin. The core body temperature falls during the night and reaches its lowest point (nadir) in the early morning, after which it starts to rise again. Melatonin secretion follows a curve which is almost inverse compared to the core body temperature rhythm, and is sensitive to light exposure which inhibits melatonin secretion. 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.
Sleep is known to be most easily initiated when the core body temperature is falling and as the melatonin level is rising. It is also known to be most easily initiated in a timeframe of six hours before nadir until a couple of hours after nadir of the core body temperature.
Evening-type individuals experience increased sleepiness and poorer performances during the early hours of the morning, as there is a mismatch between their circadian rhythms and their requirement of being awake at such early hours. Sleepiness is known to have severe implications for performance.
However, as mentioned, the SCN outputs are entrainable and light is the strongest time-giver for individuals' circadian pacemakers. Thus, the timing of light exposure has the potential to either phase advance or phase delay one's circadian rhythm. Exposure to light in the hours before nadir, during the evening, will lead to individuals delaying their circadian rhythm. On the other side, exposure to light in the hours after nadir, during the morning hours, has the potential to phase advance individuals' circadian rhythms. Light can shift the circadian phase, but this effect is dependent on the timing of light, duration of light exposure, and the intensity of light where higher intensities have been demonstrated to be associated with greater effects. Another property of light concerns the wavelengths that it emits, where blue light has been shown to produce significantly stronger phase shifting effects than lights of other wavelengths of the visible spectrum. The effects of blue-light on the circadian system has been attributed to a photoresponsive cell population in the retina that contains the photopigment melanopsin, which is highly sensitive to blue light. These cells send signals directly to the SCN, and also form connections to areas associated with wakefulness such as the striatum and the brain stem. The sensitivity to melanopsin has been demonstrated to be highest in a blue light range around 460 nm.
To the best of our knowledge, no study has been conducted to test the effects of a blue monochromatic light intervention administered via standard room lightning on phase advancement of the circadian rhythms of evening-type individuals. Consequently, our aim is to assess whether blue light as compared to standard white light, administered via standard room lightning, can alter the sleep and circadian rhythm of evening-type individuals, causing a phase advance.
Hypothesis:
Three consecutive mornings of one hour exposure to monochromatic light (40 lx, irradiance = 88,79 µW/cm2) with peak wavelength of 455 nm (blue light) will, compared to full spectrum light (2500 Kelvin) with equal photon flux as the blue light: a) lead to a phase advance of the circadian rhythm of evening-type individuals; b) increase waking function assessed with subjective and objective measures in the morning; and c) decrease participants self-reported sleepiness in the morning, d) reduce sleep onset latency and e) advance sleep onset time.
We will adjust the light intensity to make sure that the photon energy is the same across the two conditions.
Methods
Sample and procedure:
Our aim is to recruit a sample of minimum 34 participants from the University of Bergen. Inclusion criteria is scoring below 42 on the Horne-Östberg Morningness-Eveningness Questionnaire, as this categorizes moderate and definitely evening types. 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. The participants will be exposed to the blue light intervention in a randomized, blinded, controlled study. The participants will be assessed with subjective and objective measures of sleep for 3 days (Tuesday - Thursday) a week before the three-day blue light intervention. They will also be assessed with the same subjective and objective measures during the three-day intervention period. More precisely, sleep will be assessed by actigraphy and sleep diary. One day before the intervention and one day after the intervention, circadian rhythm will be measured by saliva samples for estimation of dim light melatonin onset. Flexibility will also be measured before intervention through the Circadian Type Inventory. Waking function will be assessed on the days the intervention is given with the Karolinska Sleepiness Scale and Psychomotor Vigilance Task.
Instruments/measures:
Circadian Type Inventory: an instrument with two factors. Individuals scoring high on the first dimension (Flexible/Rigid) are more flexible in their ability to stay awake at odd times of day or night. Those who score high on the second factor (Languid/Vigorous) tend to report difficulty in overcoming drowsiness, especially in the morning. CTI will be distributed to participants before the light intervention.
Munich ChronoType Questionnaire: a useful tool for determining chronotype based on sleep behaviors, such as bed- and rise-times, clock time when one becomes fully awake, in addition to some other points (e.g., sleep latency). MCTQ will be distributed to participants before the light intervention.
The Horne-Östberg Morningness-Eveningness Questionnaire (MEQ): a test that has been widely used to assess morningness-eveningness. MEQ will be distributed to participants for screening purposes.
Mood Disorder Questionnaire (MDQ): MDQ is a validated self-report instrument that screens for the presence of a lifetime history of bipolar disorder. It contains 13 yes/no items that cover topics such as mood, self-confidence, energy, sociability, interest in sex, loquaciousness, distractibility, and other behaviors. There are in addition two questions assessing whether the symptoms ever co-occurred and to which degree the symptoms caused functional impairment. A positive case entails endorsement of 7 or more of the 13 symptoms, endorsement of the co-occurrence item and reporting moderate or serious degree of functional impairment. The MDQ will only be administered for screening purposes at baseline.
Actigraphy: Wrist-worn accelerometers and clocks to be worn during the same period as the sleep diary. Data can be converted to objective sleep parameters. This watch will be worn the week before intervention for three days, on the night before Wednesday, Thursday and Friday. It will also be worn in the intervention week on the three intervention days, on the night before Wednesday, Thursday and Friday.
Sleep diary: Daily subjective estimates of bedtime, rise-time, sleep latency, number of awakenings, wake time after sleep onset, final awakening time, rise time, total sleep time, sleep efficiency, sleep quality and daytime functioning.
The questionnaire will be distributed to the participants the week before intervention for three days, on the night before Wednesday, Thursday and Friday. It will also be given in the intervention week on the three intervention days, on the night before Wednesday, Thursday and Friday. Two of the questions are filled before the participants go to bed, and the rest is filled when they wake up in the morning.
Dim light melatonin onset (DLMO): DLMO will be assessed by collecting saliva samples every hour in the evening, starting from 19:00 until one hour after normal bedtime. DLMO samples will be collected one day before the intervention and the day after the intervention period. Saliva collection and analyses will follow procedures previously used by our research group. Blue light blocker glasses will be worn (from one hour prior to the first sample) in order to prevent melatonin suppression during saliva sampling. DLMO will be analyzed with enzyme-linked immunosorbent assay (ELISA) (direct saliva melatonin from Bühlmann Laboratories, Schöonenbuch, Switzerland). The analytical sensitivity of this kit is 0.5 pg/ml and functional sensitivity is 1.6-20.5 pg/ml, with an interassay coefficient of variation of <12.6%. Samples will be analyzed with a Wallac plate reader from Perkin Elmer Inc. (Waltham, MA, USA).
Karolinska Sleepiness Scale (KSS): KSS comprises a single item assessing state sleepiness on a scale from 1 to 9. This instrument will be given in the laboratory on the days of the light intervention. It will be given for a total of six times per participant, twice on each intervention day, the first immediately when the participants come to the laboratory to receive the intervention, and the second after they have received one hour of light, before they leave the laboratory.
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. PVT will be given to participants on the three days of light intervention.
Statistical analysis/power analysis:
A 2 (Time; pre vs post) x 2 (Group; blue vs. full spectrum light) ANOVA will be used for analyzing the results. Power analysis was conducted with G*Power, version 3.17. Setting the effect size to medium (d=0.50), power to .80, alpha to .05, r between repeated measures to .50, shows that 34 participants will be needed in order to detect a significant Time x Group interaction.
- Being tested
- Blue light exposure, Full spectrum light exposure
- Keywords
- Circadian rhythm, Sleep, evening-type individuals, morningness-eveningness, blue light, monochromatic light, randomized controlled trial
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue light exposureOther
Light administered through ceiling mounted light emitting diode (LED)-based room lighting.
Full spectrum light exposureOther
Light administered through ceiling mounted light emitting diode (LED)-based room lighting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Full spectrum light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Based on sleep diary (subjective measure of sleep length) and actigraphy (objective measure of sleep length).
The sleep diary consists of no pre-determined scale. It is a diary where the participants fill in a time-point (e.g. the time they went to bed, the time they turned off the lights, how long it took until they fell as asleep, and when they woke up in the morning). The measurement unit is minutes.
Since the comparison is made across days/measurement points, only one composite parameter for each condition will be calculated.
Measured: 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
Based on sleep diary (subjective measure of sleep onset time) and actigraphy (objective measure of sleep onset time).
The sleep consists of items that require a time-point as the answer. E.g.: What time did you wake up, to which you can reply 09:00 or any value within a 24-hour day.
Since the comparison is made across days/measurement points, only one composite parameter for each condition will be calculated.
Measured: 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
Based on sleep diary (subjective measure of wake-up time) and actigraphy (objective measure of wake-up time).
The sleep diary consists of items that require a time-point as the answer. E.g.: What time did you wake up, to which you can reply 08:30 or any value within a 24-hour day.
Since the comparison is made across days/measurement points, only one composite parameter for each condition will be calculated.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start25 Sep 2018
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Circadian Rhythm Sleep Disorder, Delayed Sleep PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, single-blinded trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ståle Pallesen, Principal investigator, The University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758768
- Sponsor's protocol ID
- 271561
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
PubMed 2265922Berson DM, Dunn FA, Takao M. Phototransduction by retinal ganglion cells that set the circadian clock. Science. 2002 Feb 8;295(5557):1070-3. doi: 10.1126/science.1067262.
PubMed 11834835Besoluk S, Onder I, Deveci I. Morningness-eveningness preferences and academic achievement of university students. Chronobiol Int. 2011 Mar;28(2):118-25. doi: 10.3109/07420528.2010.540729.
PubMed 21231873Bjorvatn B, Pallesen S. A practical approach to circadian rhythm sleep disorders. Sleep Med Rev. 2009 Feb;13(1):47-60. doi: 10.1016/j.smrv.2008.04.009. Epub 2008 Oct 8.
PubMed 18845459Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
PubMed 22294820Di Milia, L., Smith, P. A., & Folkard, S. (2005). A validation of the revised circadian type inventory in a working sample. Personality and Individual differences, 39(7), 1293-1305.
Do MT, Yau KW. Intrinsically photosensitive retinal ganglion cells. Physiol Rev. 2010 Oct;90(4):1547-81. doi: 10.1152/physrev.00013.2010.
PubMed 20959623Escribano, C., Díaz-Morales, J. F., Delgado, P., & Collado, M. J. (2012). Morningness/eveningness and school performance among Spanish adolescents: Further evidence. Learning and Individual Differences, 22(3), 409-413.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Figueiro MG, Bierman A, Rea MS. A train of blue light pulses delivered through closed eyelids suppresses melatonin and phase shifts the human circadian system. Nat Sci Sleep. 2013 Oct 4;5:133-41. doi: 10.2147/NSS.S52203. eCollection 2013.
PubMed 24124400Goldstein D, Hahn CS, Hasher L, Wiprzycka UJ, Zelazo PD. Time of day, Intellectual Performance, and Behavioral Problems in Morning Versus Evening type Adolescents: Is there a Synchrony Effect? Pers Individ Dif. 2007 Feb;42(3):431-440. doi: 10.1016/j.paid.2006.07.008.
PubMed 17268574Hirschfeld RM, Williams JB, Spitzer RL, Calabrese JR, Flynn L, Keck PE Jr, Lewis L, McElroy SL, Post RM, Rapport DJ, Russell JM, Sachs GS, Zajecka J. Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. Am J Psychiatry. 2000 Nov;157(11):1873-5. doi: 10.1176/appi.ajp.157.11.1873.
PubMed 11058490Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
PubMed 1027738Horne JA, Ostberg O. Individual differences in human circadian rhythms. Biol Psychol. 1977 Sep;5(3):179-90. doi: 10.1016/0301-0511(77)90001-1.
PubMed 922076Kaida K, Takahashi M, Akerstedt T, Nakata A, Otsuka Y, Haratani T, Fukasawa K. Validation of the Karolinska sleepiness scale against performance and EEG variables. Clin Neurophysiol. 2006 Jul;117(7):1574-81. doi: 10.1016/j.clinph.2006.03.011. Epub 2006 May 6.
PubMed 16679057
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms
- ClinicalTrials.gov ID
- NCT03758768
- Acronym / sponsor ID
- 271561
- Keywords
- Circadian rhythm, Sleep, evening-type individuals, morningness-eveningness, blue light, monochromatic light, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Morningness/eveningness is a phenomenon that reflects the tendency to be an "early morning bird" or a "late night owl" and is thus a source of inter-individual variation in timing of sleep and other behaviors. Evening- and morning-type individuals demonstrate differences that derive internally regarding the circadian phase of their endogenous biological clock. A certain group of individuals referred to as morning-type individuals have been consistently found to perform better in the morning, whereas evening-type individuals appear to be more alert and perform better in the evening. Morning-type individuals have earlier bed- and rise times than evening-types, while evening-type individuals have been known to report significantly later bed- and rise-times compared to morning-type individuals. In addition, evening-type adolescents have been known to demonstrate poorer academic and intellectual performances during their nonpreferred, i.e., early hours of the day.
Circadian rhythms are known as biological processes that display endogenous, entrainable oscillations in a period of about 24 hours. These rhythms have been found to be controlled by the circadian pacemaker, which is located in the suprachiasmatic nuclei (SCN) of the hypothalamus. These 24-hour rhythms manifest themselves in an observable manner within numerous physiological measures, such as the sleep-wake cycle, the core body temperature, and the excretion of hormones such as melatonin. The core body temperature falls during the night and reaches its lowest point (nadir) in the early morning, after which it starts to rise again. Melatonin secretion follows a curve which is almost inverse compared to the core body temperature rhythm, and is sensitive to light exposure which inhibits melatonin secretion. 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.
Sleep is known to be most easily initiated when the core body temperature is falling and as the melatonin level is rising. It is also known to be most easily initiated in a timeframe of six hours before nadir until a couple of hours after nadir of the core body temperature.
Evening-type individuals experience increased sleepiness and poorer performances during the early hours of the morning, as there is a mismatch between their circadian rhythms and their requirement of being awake at such early hours. Sleepiness is known to have severe implications for performance.
However, as mentioned, the SCN outputs are entrainable and light is the strongest time-giver for individuals' circadian pacemakers. Thus, the timing of light exposure has the potential to either phase advance or phase delay one's circadian rhythm. Exposure to light in the hours before nadir, during the evening, will lead to individuals delaying their circadian rhythm. On the other side, exposure to light in the hours after nadir, during the morning hours, has the potential to phase advance individuals' circadian rhythms. Light can shift the circadian phase, but this effect is dependent on the timing of light, duration of light exposure, and the intensity of light where higher intensities have been demonstrated to be associated with greater effects. Another property of light concerns the wavelengths that it emits, where blue light has been shown to produce significantly stronger phase shifting effects than lights of other wavelengths of the visible spectrum. The effects of blue-light on the circadian system has been attributed to a photoresponsive cell population in the retina that contains the photopigment melanopsin, which is highly sensitive to blue light. These cells send signals directly to the SCN, and also form connections to areas associated with wakefulness such as the striatum and the brain stem. The sensitivity to melanopsin has been demonstrated to be highest in a blue light range around 460 nm.
To the best of our knowledge, no study has been conducted to test the effects of a blue monochromatic light intervention administered via standard room lightning on phase advancement of the circadian rhythms of evening-type individuals. Consequently, our aim is to assess whether blue light as compared to standard white light, administered via standard room lightning, can alter the sleep and circadian rhythm of evening-type individuals, causing a phase advance.
Hypothesis:
Three consecutive mornings of one hour exposure to monochromatic light (40 lx, irradiance = 88,79 µW/cm2) with peak wavelength of 455 nm (blue light) will, compared to full spectrum light (2500 Kelvin) with equal photon flux as the blue light: a) lead to a phase advance of the circadian rhythm of evening-type individuals; b) increase waking function assessed with subjective and objective measures in the morning; and c) decrease participants self-reported sleepiness in the morning, d) reduce sleep onset latency and e) advance sleep onset time.
We will adjust the light intensity to make sure that the photon energy is the same across the two conditions.
Methods
Sample and procedure:
Our aim is to recruit a sample of minimum 34 participants from the University of Bergen. Inclusion criteria is scoring below 42 on the Horne-Östberg Morningness-Eveningness Questionnaire, as this categorizes moderate and definitely evening types. 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. The participants will be exposed to the blue light intervention in a randomized, blinded, controlled study. The participants will be assessed with subjective and objective measures of sleep for 3 days (Tuesday - Thursday) a week before the three-day blue light intervention. They will also be assessed with the same subjective and objective measures during the three-day intervention period. More precisely, sleep will be assessed by actigraphy and sleep diary. One day before the intervention and one day after the intervention, circadian rhythm will be measured by saliva samples for estimation of dim light melatonin onset. Flexibility will also be measured before intervention through the Circadian Type Inventory. Waking function will be assessed on the days the intervention is given with the Karolinska Sleepiness Scale and Psychomotor Vigilance Task.
Instruments/measures:
Circadian Type Inventory: an instrument with two factors. Individuals scoring high on the first dimension (Flexible/Rigid) are more flexible in their ability to stay awake at odd times of day or night. Those who score high on the second factor (Languid/Vigorous) tend to report difficulty in overcoming drowsiness, especially in the morning. CTI will be distributed to participants before the light intervention.
Munich ChronoType Questionnaire: a useful tool for determining chronotype based on sleep behaviors, such as bed- and rise-times, clock time when one becomes fully awake, in addition to some other points (e.g., sleep latency). MCTQ will be distributed to participants before the light intervention.
The Horne-Östberg Morningness-Eveningness Questionnaire (MEQ): a test that has been widely used to assess morningness-eveningness. MEQ will be distributed to participants for screening purposes.
Mood Disorder Questionnaire (MDQ): MDQ is a validated self-report instrument that screens for the presence of a lifetime history of bipolar disorder. It contains 13 yes/no items that cover topics such as mood, self-confidence, energy, sociability, interest in sex, loquaciousness, distractibility, and other behaviors. There are in addition two questions assessing whether the symptoms ever co-occurred and to which degree the symptoms caused functional impairment. A positive case entails endorsement of 7 or more of the 13 symptoms, endorsement of the co-occurrence item and reporting moderate or serious degree of functional impairment. The MDQ will only be administered for screening purposes at baseline.
Actigraphy: Wrist-worn accelerometers and clocks to be worn during the same period as the sleep diary. Data can be converted to objective sleep parameters. This watch will be worn the week before intervention for three days, on the night before Wednesday, Thursday and Friday. It will also be worn in the intervention week on the three intervention days, on the night before Wednesday, Thursday and Friday.
Sleep diary: Daily subjective estimates of bedtime, rise-time, sleep latency, number of awakenings, wake time after sleep onset, final awakening time, rise time, total sleep time, sleep efficiency, sleep quality and daytime functioning.
The questionnaire will be distributed to the participants the week before intervention for three days, on the night before Wednesday, Thursday and Friday. It will also be given in the intervention week on the three intervention days, on the night before Wednesday, Thursday and Friday. Two of the questions are filled before the participants go to bed, and the rest is filled when they wake up in the morning.
Dim light melatonin onset (DLMO): DLMO will be assessed by collecting saliva samples every hour in the evening, starting from 19:00 until one hour after normal bedtime. DLMO samples will be collected one day before the intervention and the day after the intervention period. Saliva collection and analyses will follow procedures previously used by our research group. Blue light blocker glasses will be worn (from one hour prior to the first sample) in order to prevent melatonin suppression during saliva sampling. DLMO will be analyzed with enzyme-linked immunosorbent assay (ELISA) (direct saliva melatonin from Bühlmann Laboratories, Schöonenbuch, Switzerland). The analytical sensitivity of this kit is 0.5 pg/ml and functional sensitivity is 1.6-20.5 pg/ml, with an interassay coefficient of variation of <12.6%. Samples will be analyzed with a Wallac plate reader from Perkin Elmer Inc. (Waltham, MA, USA).
Karolinska Sleepiness Scale (KSS): KSS comprises a single item assessing state sleepiness on a scale from 1 to 9. This instrument will be given in the laboratory on the days of the light intervention. It will be given for a total of six times per participant, twice on each intervention day, the first immediately when the participants come to the laboratory to receive the intervention, and the second after they have received one hour of light, before they leave the laboratory.
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. PVT will be given to participants on the three days of light intervention.
Statistical analysis/power analysis:
A 2 (Time; pre vs post) x 2 (Group; blue vs. full spectrum light) ANOVA will be used for analyzing the results. Power analysis was conducted with G*Power, version 3.17. Setting the effect size to medium (d=0.50), power to .80, alpha to .05, r between repeated measures to .50, shows that 34 participants will be needed in order to detect a significant Time x Group interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, controlled, single-blinded trial.
| Arm | Type | Receives |
|---|---|---|
| Blue monochromatic light | Experimental | Other: Blue light exposureThree 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. |
| Full spectrum light control condition | Active comparator | Other: Full spectrum light exposureThree 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Scoring below 42 on the Horne-Östberg Morningness-Eveningness Questionnaire, as this categorizes moderate and definitely evening types (Horne \& Östberg, 1976).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue light exposureLight administered through ceiling mounted light emitting diode (LED)-based room lighting. | Other | Blue monochromatic light |
| Full spectrum light exposureLight administered through ceiling mounted light emitting diode (LED)-based room lighting. | Other | Full spectrum light control condition |
Primary outcome
Change scores from baseline to post-intervention in Dim light melatonin onset (DLMO)
Time frame: 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)
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.
Change scores of Feeling of Morning Wakefulness, measured by Sleep Diary
Time frame: Tuesday, Wednesday and Thursday (baseline; week before intervention); Tuesday, Wednesday and Thursday (week of light intervention)
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.
Psychomotor Vigilance Task (PVT)
Time frame: 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.
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.
Karolinska Sleepiness Scale (KSS)
Time frame: 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.
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.
3 secondary outcomes
Changes scores in Sleep Length
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Background: PubMed 2265922Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
- Background: PubMed 11834835Berson DM, Dunn FA, Takao M. Phototransduction by retinal ganglion cells that set the circadian clock. Science. 2002 Feb 8;295(5557):1070-3. doi: 10.1126/science.1067262.
- Background: PubMed 21231873Besoluk S, Onder I, Deveci I. Morningness-eveningness preferences and academic achievement of university students. Chronobiol Int. 2011 Mar;28(2):118-25. doi: 10.3109/07420528.2010.540729.
- Background: PubMed 18845459Bjorvatn B, Pallesen S. A practical approach to circadian rhythm sleep disorders. Sleep Med Rev. 2009 Feb;13(1):47-60. doi: 10.1016/j.smrv.2008.04.009. Epub 2008 Oct 8.
- Background: PubMed 22294820Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
- BackgroundDi Milia, L., Smith, P. A., & Folkard, S. (2005). A validation of the revised circadian type inventory in a working sample. Personality and Individual differences, 39(7), 1293-1305.
- Background: PubMed 20959623Do MT, Yau KW. Intrinsically photosensitive retinal ganglion cells. Physiol Rev. 2010 Oct;90(4):1547-81. doi: 10.1152/physrev.00013.2010.
- BackgroundEscribano, C., Díaz-Morales, J. F., Delgado, P., & Collado, M. J. (2012). Morningness/eveningness and school performance among Spanish adolescents: Further evidence. Learning and Individual Differences, 22(3), 409-413.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 24124400Figueiro MG, Bierman A, Rea MS. A train of blue light pulses delivered through closed eyelids suppresses melatonin and phase shifts the human circadian system. Nat Sci Sleep. 2013 Oct 4;5:133-41. doi: 10.2147/NSS.S52203. eCollection 2013.
- Background: PubMed 17268574Goldstein D, Hahn CS, Hasher L, Wiprzycka UJ, Zelazo PD. Time of day, Intellectual Performance, and Behavioral Problems in Morning Versus Evening type Adolescents: Is there a Synchrony Effect? Pers Individ Dif. 2007 Feb;42(3):431-440. doi: 10.1016/j.paid.2006.07.008.
- Background: PubMed 11058490Hirschfeld RM, Williams JB, Spitzer RL, Calabrese JR, Flynn L, Keck PE Jr, Lewis L, McElroy SL, Post RM, Rapport DJ, Russell JM, Sachs GS, Zajecka J. Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. Am J Psychiatry. 2000 Nov;157(11):1873-5. doi: 10.1176/appi.ajp.157.11.1873.
- Individual participant dataSharing planned: Undecided
Related trials for Circadian Rhythm Sleep Disorder, Delayed Sleep Phase
RecruitingPhase 4
Lemborexant in Delayed Sleep Phase Syndrome
Delayed Sleep Phase Syndrome
Recruiting
Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder
Delayed Sleep Phase Syndrome, Delayed Sleep Phase
Recruiting
Pupillometry in Delayed Sleep Wake Phase Disorder
Delayed Sleep-Wake Phase Disorder
RecruitingPhase 2
Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
Bipolar Disorder, Delayed Sleep-Wake Phase Disorder
RecruitingPhase 3
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ståle Pallesen principal investigator
The University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light exposure and Full spectrum light exposure in people with Circadian Rhythm Sleep Disorder, Delayed Sleep Phase and Sleep, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores from baseline to post-intervention in Dim light melatonin onset (DLMO) (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03758768, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.