The Effects of Bright Light Therapy on Adolescent's Sleep Quality and Well-being

Sponsor

Reykjavik University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05555186

Collaborator

The Icelandic Research Fund (Other)

300

Enrollment

Location

Arms

8.8

Anticipated Duration (Months)

34.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sleep problems are common among adolescents which can have a variety of serious biological, emotional, cognitive and psychological consequences. Numerous studies have shown that adolescents who suffer from insufficient sleep and poor sleep quality experience decreased mental well-being which is a growing concern in modern societies.

Effective interventions that enhance sleep quality among adolescents are lacking. One possible reason for sleep problems among adolescents is disturbance in the body's circadian rhythms. As light is known to be the main coordinating factor in circadian rhythms, light therapy is an auspicious method which aims to entrain the circadian rhythms, thereby enhancing sleep quality and well-being. Indeed, bright light therapy (BLT) has been shown to be a promising treatment to improve sleep and decrease depressive symptoms among different patient groups. However, BLT interventions among healthy adolescents are needed. Therefore, the current study will investigate whether BLT in classrooms of 16 year old students can improve their sleep quality and well-being. The results from the study can be important as it is the first one to examine whether light intensity in the classroom affects sleep and well-being among adolescents. Furthermore, if the hypothesis will be supported, a simple and relatively inexpensive method can be implemented to promote better sleep quality and thus have an extensive effect on adolescent's well-being.

Aim 1 - Assess whether BLT will improve sleep quality of adolescents. Aim 2 - Assess whether BLT will decrease depressive symptoms in adolescents. Aim 3 - Assess whether BLT will improve mood in adolescents.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance Depression Mood Circadian Rhythms	Device: BWL classrooms (Experimental) Device: DWL classrooms (Comparison)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of School Based Ambient Bright White Light Intervention on Adolescents´ Sleep Quality, Depression and Mood

Actual Study Start Date :

Sep 5, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental light: Sleep quality and well-being Exposure to experimental systematic light exposure (BWL) in classroom where students are located every school day from 8:30AM until the school finishes between 3 and 4PM	Device: BWL classrooms (Experimental) Adolescents in the BWL classrooms will be exposed to the circadian stimulating bright light (600-1000lx) to maintain alertness. The programming of the LED lighting system in the intervention group (BWL) will be tuned to provide equal stimuli to the cone and melanopsin-containing photoreceptors measured at the eye height (1.2 m above floor level for sitting position) approximately in the range 4500 -5500 K (cool white light)or between 600 and 1000 lx.
Sham Comparator: Comparison light: Sleep quality and well-being Exposure to comparison systematic light exposure (DWL) in classroom where students are located every school day from 8:30AM until the school finishes between 3 and 4PM	Device: DWL classrooms (Comparison) Participants in DWL classrooms will receive conventional light from the same kind of equipment as used for the intervention group, only not applying high circadian stimulation(300lx). In order to replicate conventional lighting in the classrooms, the programming of the new LED lighting system in the control group (DWL) will meet the minimum requirements according to EN12464-181, or at least 300 lx measured at table height for a light source rated at 3000 K (warm white light).
No Intervention: Unchanged lightning Conventional lightning in classrooms where students are located every school day from 8:30AM until the school finishes between 3 and 4PM

Arm

Intervention/Treatment

Experimental: Experimental light: Sleep quality and well-being

Exposure to experimental systematic light exposure (BWL) in classroom where students are located every school day from 8:30AM until the school finishes between 3 and 4PM

Device: BWL classrooms (Experimental)

Adolescents in the BWL classrooms will be exposed to the circadian stimulating bright light (600-1000lx) to maintain alertness. The programming of the LED lighting system in the intervention group (BWL) will be tuned to provide equal stimuli to the cone and melanopsin-containing photoreceptors measured at the eye height (1.2 m above floor level for sitting position) approximately in the range 4500 -5500 K (cool white light)or between 600 and 1000 lx.

Sham Comparator: Comparison light: Sleep quality and well-being

Exposure to comparison systematic light exposure (DWL) in classroom where students are located every school day from 8:30AM until the school finishes between 3 and 4PM

Device: DWL classrooms (Comparison)

Participants in DWL classrooms will receive conventional light from the same kind of equipment as used for the intervention group, only not applying high circadian stimulation(300lx). In order to replicate conventional lighting in the classrooms, the programming of the new LED lighting system in the control group (DWL) will meet the minimum requirements according to EN12464-181, or at least 300 lx measured at table height for a light source rated at 3000 K (warm white light).

No Intervention: Unchanged lightning

Conventional lightning in classrooms where students are located every school day from 8:30AM until the school finishes between 3 and 4PM

Outcome Measures

Primary Outcome Measures

ActTrust: Sleep/wake activity [Up to 9 months]
Measure of night-time and daytime sleep (combined minutes of sleep, sleep onset latency, and sleep efficiency. Attained from a wrist actigraph.
ActTrust: Circadian Activity Rhythms [Up to 9 months]
Rest-activity patterns (amplitude, acrophase, mesor) recorded by a wrist actigraph, combined into a circadian activity variable
ActTrust: Daily physical activity [Up to 9 months]
Measure attained from wrist actigraph showing activity levels of participants
ActTrust: Environmental light exposure [Up to 9 months]
Measure attained from a wrist actigraph, showing the types of light a participant is exposed to.
Pittsburgh Sleep Quality Index [Up to 9 months]
The Pittsburgh Sleep Quality Index assesses sleep quality. his measure is composed of 19 items that generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). The sum of the seven component scores yields one global score. A person with a global score above 5is considered to have sleep disturbances. The scale has the test-retest reliability of r=.85 and estimated internal consistency of α=.80.
The Warwick-Edinburgh Mental Well-being Scale [Up to 9 months]
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), 7 item short version) will be used to assess overall well-being during the last two weeks. Each item on the list is rated on a 5-point Likert scale ranging from "never" to "very often".
Munich Chronotype Questionnaire (MCTQ) [Up to 9 months]
The Munich Chronotype Questionnaire (MCTQ) is a self-reported measure of chronotype that addresses questions related to sleep and wakefulness. The participants were asked to answer the list based on experience of a typical week in their current situation.
PROMIS cognitive function and cognitive abilities 8a [Up to 9 months]
PROMIS® (Patient-Reported Outcomes Measurement Information System) cognitive function and cognitive abilities 8a consist of 8 self-report item rated on a five point Likert scale ranging from "never" to "very often" on the Cognitive Function scale and "not at all" to "very much" on the Cognitive Abilities scale. Both PROMIS item banks show good psychometric properties, such as a high internal consistency (α =.94 for each).
Depression Anxiety Stress Scales (DASS 21) [Up to 9 months]
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The participants were asked to read the following statement and circle a number 0, 1, 2 or 3 which indicates how much the statement applied to the participant over the past week.
The Cleveland Adolescent Sleepiness Questionnaire [Up to 9 months]
The Cleveland Adolescent Sleepiness Questionnaire (CASQ), a brief, self-completed instrument to measure excessive daytime sleepiness in adolescents. For each statement, the participants were asked to mark the circle under the response that best fits with how often it applies to them. Each item on the list is rated on a 5-point Likert scale ranging from "never" to "almost daily".
Adolescents Daytime Naps [Up to 9 months]
Adolescents Daytime Naps measure how often participants fall asleep daily. If they rest or fall asleep during the day, it is called a day-nap, whether they have planned to go to bed or not. Daytime hours also cover shorter periods of time when they rest or fall asleep, for example over a computer / television or reading. First we ask about daytime hours on weekdays and then about daytime hours on weekends. If participants go to bed more than once a day, they should record the total time staying in bed.
Adolescents Screen Time [Up to 9 months]
The participants were asked how long time they spend on a computer, tablet, game console, television, phone or other display device in the following: school lessions, work/internship, computers or social media. The answer possibilities are 0-23 hours and 0-50 minutes.
Physical activity [Up to 9 months]
The participants were asked two questions about their physical activity during the last seven days. The participants were asked how long time per one day they usually spend participating in physical activity. Include the time they spent waking, jogging, running, cycling, exercising or doing some kind of sport. The answer possibilities range from "less than 1/2 hour a day" up to "more than 6 hours a day" The participants were also asked how many days of the last seven days they participated in physical activity for at least 60 minutes so that their heart rate increased and they sometimes got out of breath. The participation may include physical activity, workout, brisk walking, cycling in free time or transportation between different locations. The answers range from "almost never" up to "seven days".
Sedentary behaviour [Up to 9 months]
The participants were asked how long time they usually spend sitting the last seven days. The period starts when they wake up in the morning and ends when they goes to bed for the night. Include time spent at work, at school, at home, and in their free time. This can include time spent at a desk, dining table, visiting, watching movies, reading, or in front of a television, computer, or other monitor. The answer possibilities range from "30 minutes per day" up to "more than 16 hours per day".