Sleep Clinical Trial
Official title:
The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms
Verified date | November 2018 |
Source | University of Bergen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | October 22, 2018 |
Est. primary completion date | October 22, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Scoring below 42 on the Horne-Östberg Morningness-Eveningness Questionnaire, as this categorizes moderate and definitely evening types (Horne & Östberg, 1976). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Norway | University of Bergen | Bergen | Hordaland |
Lead Sponsor | Collaborator |
---|---|
University of Bergen |
Norway,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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. | |
Primary | 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 | 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. |
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. | |
Secondary | 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. |
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. | |
Secondary | 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. |
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. |
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