Sleep DisturbanceNCT05555186
The Effects of Bright Light Therapy on Adolescent's Sleep Quality and Well-being
A study testing BWL classrooms (Experimental) and DWL classrooms (Comparison) in people with Sleep Disturbance and Depression, run by Reykjavik University at 1 site in Iceland.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Depression, Mood
- What is being tested?
- BWL classrooms (Experimental) and DWL classrooms (Comparison)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteIceland
- Study dates
- 5 Sep 2022to 31 May 2023
- 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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- First-year students at the school where the research takes place.
- Participants provide written informed consent.
- Parents or caregivers of participants provide informed consent.
- Read and write Icelandic.
Who cannot join
- Not first-year students.
- Participant or parent does not provide written informed consent.
- Not capable of reading and writing Icelandic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of School Based Ambient Bright White Light Intervention on Adolescents´ Sleep Quality, Depression and Mood
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 adolescents' 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.
- Conditions
- Sleep Disturbance, Depression, Mood, Circadian Rhythms
- Being tested
- BWL classrooms (Experimental), DWL classrooms (Comparison)
- Keywords
- Light Therapy, Sleep Disturbance, Adolescents, Well-being, Circadian Rhythms
- Medical subject headings
- Parasomnias, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BWL classrooms (Experimental)Device
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.
DWL classrooms (Comparison)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental light: Sleep quality and well-being | Experimental | Exposure to experimental systematic light exposure (BWL) in classroom where students are located every school day from 8:30 AM until the school finishes between 3 and 4 PM Receives: Device: BWL classrooms (Experimental) |
| Comparison light: Sleep quality and well-being | Sham comparator | Exposure to comparison systematic light exposure (DWL) in classroom where students are located every school day from 8:30 AM until the school finishes between 3 and 4 PM Receives: Device: DWL classrooms (Comparison) |
| Unchanged lightning | No intervention | Conventional lightning in classrooms where students are located every school day from 8:30 AM until the school finishes between 3 and 4 PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
ActTrust: Sleep/wake activity
Measure of night-time and daytime sleep (combined minutes of sleep, sleep-onset latency, and sleep efficiency. Recorded by a wrist actigraph (ActTrust).
Measured: Up to 9 months
ActTrust: Circadian Activity Rhythms
Rest-activity patterns (amplitude, acrophase, mesor) recorded by a wrist actigraph (ActTrust), combined into a circadian activity variable.
Measured: Up to 9 months
ActTrust: Daily physical activity
Measure recorded by a wrist actigraph (ActTrust) showing activity levels of participants.
Measured: Up to 9 months
ActTrust: Environmental light exposure
Measure recorded by a wrist actigraph (ActTrust), showing the types of light a participant is exposed to.
Measured: Up to 9 months
Pittsburgh Sleep Quality Index
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 5 is considered to have sleep disturbances. The scale has the test-retest reliability of r=.85 and estimated internal consistency of α=.80.
Measured: Up to 9 months
The Warwick-Edinburgh Mental Well-being Scale
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".
Measured: Up to 9 months
Munich Chronotype Questionnaire (MCTQ)
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.
Measured: Up to 9 months
PROMIS cognitive function and cognitive abilities 8a
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).
Measured: Up to 9 months
Depression Anxiety Stress Scales (DASS 21)
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.
Measured: Up to 9 months
The Cleveland Adolescent Sleepiness Questionnaire
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".
Measured: Up to 9 months
Adolescents Daytime Naps
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 participants are asked 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.
Measured: Up to 9 months
Adolescents Screen Time
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 lessons, work/internship, computers or social media. The answer possibilities are 0-23 hours and 0-50 minutes.
Measured: Up to 9 months
Physical activity
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".
Measured: Up to 9 months
Sedentary behaviour
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".
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start5 Sep 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reykjavik University
- Sponsor type
- University, hospital or other
- Collaborators
- Icelandic Research Center
- Responsible party
- Principal investigator, Birna Baldursdottir, Reykjavik University
- Investigators
- Birna Baldursdottir, PhD, Principal investigator, Reykjavik UniversityHeiddis B. Valdimarsdottir, PhD, Study chair, Reykjavik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555186
- Sponsor's protocol ID
- VSN-21-143
- Other IDs
- 217543-051
- Status last verified
- Apr 2024
- First submitted
- 16 Sep 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berger AT, Wahlstrom KL, Widome R. Relationships between sleep duration and adolescent depression: a conceptual replication. Sleep Health. 2019 Apr;5(2):175-179. doi: 10.1016/j.sleh.2018.12.003. Epub 2019 Jan 30.
PubMed 30928118Brand S, Lemola S, Mikoteit T, Holsboer-Trachsler E, Kalak N, Bahmani DS, Puhse U, Ludyga S, Gerber M. [Sleep and Psychological Functioning of Children and Adolescents - a Narrative Review]. Prax Kinderpsychol Kinderpsychiatr. 2019 Feb;68(2):128-145. doi: 10.13109/prkk.2019.68.2.128. German.
PubMed 30757973Chaput JP, Gray CE, Poitras VJ, Carson V, Gruber R, Olds T, Weiss SK, Connor Gorber S, Kho ME, Sampson M, Belanger K, Eryuzlu S, Callender L, Tremblay MS. Systematic review of the relationships between sleep duration and health indicators in school-aged children and youth. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S266-82. doi: 10.1139/apnm-2015-0627.
PubMed 27306433Chang AM, Aeschbach D, Duffy JF, Czeisler CA. Evening use of light-emitting eReaders negatively affects sleep, circadian timing, and next-morning alertness. Proc Natl Acad Sci U S A. 2015 Jan 27;112(4):1232-7. doi: 10.1073/pnas.1418490112. Epub 2014 Dec 22.
PubMed 25535358Gariepy G, Danna S, Gobina I, Rasmussen M, Gaspar de Matos M, Tynjala J, Janssen I PhD, Kalman M PhD, Villerusa A, Husarova D, Brooks F, Elgar FJ, Klavina-Makrecka S MSc, Smigelskas K, Gaspar T, Schnohr C. How Are Adolescents Sleeping? Adolescent Sleep Patterns and Sociodemographic Differences in 24 European and North American Countries. J Adolesc Health. 2020 Jun;66(6S):S81-S88. doi: 10.1016/j.jadohealth.2020.03.013.
PubMed 32446613Gradisar M, Gardner G, Dohnt H. Recent worldwide sleep patterns and problems during adolescence: a review and meta-analysis of age, region, and sleep. Sleep Med. 2011 Feb;12(2):110-8. doi: 10.1016/j.sleep.2010.11.008. Epub 2011 Jan 22.
PubMed 21257344
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of School Based Ambient Bright White Light Intervention on Adolescents´ Sleep Quality, Depression and Mood
- ClinicalTrials.gov ID
- NCT05555186
- Acronym / sponsor ID
- VSN-21-143
- Conditions
- Sleep Disturbance, Depression, Mood, Circadian Rhythms
- Keywords
- Light Therapy, Sleep Disturbance, Adolescents, Well-being, Circadian Rhythms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Reykjavik UniversityUniversity, hospital or other
- Collaborators
- Icelandic Research Center
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 26 Sep 2022 (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.
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 adolescents' 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental light: Sleep quality and well-being | Experimental | Device: BWL classrooms (Experimental)Exposure to experimental systematic light exposure (BWL) in classroom where students are located every school day from 8:30 AM until the school finishes between 3 and 4 PM |
| Comparison light: Sleep quality and well-being | Sham comparator | Device: DWL classrooms (Comparison)Exposure to comparison systematic light exposure (DWL) in classroom where students are located every school day from 8:30 AM until the school finishes between 3 and 4 PM |
| Unchanged lightning | No intervention | –Conventional lightning in classrooms where students are located every school day from 8:30 AM until the school finishes between 3 and 4 PM |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- First-year students at the school where the research takes place.
- Participants provide written informed consent.
- Parents or caregivers of participants provide informed consent.
- Read and write Icelandic.
Key exclusion criteria (3 listed)
- Not first-year students.
- Participant or parent does not provide written informed consent.
- Not capable of reading and writing Icelandic.
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 |
|---|---|---|
| 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. | Device | Experimental light: Sleep quality and well-being |
| 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). | Device | Comparison light: Sleep quality and well-being |
Primary outcome
ActTrust: Sleep/wake activity
Time frame: Up to 9 months
Measure of night-time and daytime sleep (combined minutes of sleep, sleep-onset latency, and sleep efficiency. Recorded by a wrist actigraph (ActTrust).
ActTrust: Circadian Activity Rhythms
Time frame: Up to 9 months
Rest-activity patterns (amplitude, acrophase, mesor) recorded by a wrist actigraph (ActTrust), combined into a circadian activity variable.
ActTrust: Daily physical activity
Time frame: Up to 9 months
Measure recorded by a wrist actigraph (ActTrust) showing activity levels of participants.
ActTrust: Environmental light exposure
Time frame: Up to 9 months
Measure recorded by a wrist actigraph (ActTrust), showing the types of light a participant is exposed to.
Pittsburgh Sleep Quality Index
Time frame: 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 5 is 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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 participants are asked 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
Time frame: 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 lessons, work/internship, computers or social media. The answer possibilities are 0-23 hours and 0-50 minutes.
Physical activity
Time frame: 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
Time frame: 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".
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 16 Apr 2024.
- Background: PubMed 30928118Berger AT, Wahlstrom KL, Widome R. Relationships between sleep duration and adolescent depression: a conceptual replication. Sleep Health. 2019 Apr;5(2):175-179. doi: 10.1016/j.sleh.2018.12.003. Epub 2019 Jan 30.
- Background: PubMed 30757973Brand S, Lemola S, Mikoteit T, Holsboer-Trachsler E, Kalak N, Bahmani DS, Puhse U, Ludyga S, Gerber M. [Sleep and Psychological Functioning of Children and Adolescents - a Narrative Review]. Prax Kinderpsychol Kinderpsychiatr. 2019 Feb;68(2):128-145. doi: 10.13109/prkk.2019.68.2.128. German.
- Background: PubMed 27306433Chaput JP, Gray CE, Poitras VJ, Carson V, Gruber R, Olds T, Weiss SK, Connor Gorber S, Kho ME, Sampson M, Belanger K, Eryuzlu S, Callender L, Tremblay MS. Systematic review of the relationships between sleep duration and health indicators in school-aged children and youth. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S266-82. doi: 10.1139/apnm-2015-0627.
- Background: PubMed 25535358Chang AM, Aeschbach D, Duffy JF, Czeisler CA. Evening use of light-emitting eReaders negatively affects sleep, circadian timing, and next-morning alertness. Proc Natl Acad Sci U S A. 2015 Jan 27;112(4):1232-7. doi: 10.1073/pnas.1418490112. Epub 2014 Dec 22.
- Background: PubMed 32446613Gariepy G, Danna S, Gobina I, Rasmussen M, Gaspar de Matos M, Tynjala J, Janssen I PhD, Kalman M PhD, Villerusa A, Husarova D, Brooks F, Elgar FJ, Klavina-Makrecka S MSc, Smigelskas K, Gaspar T, Schnohr C. How Are Adolescents Sleeping? Adolescent Sleep Patterns and Sociodemographic Differences in 24 European and North American Countries. J Adolesc Health. 2020 Jun;66(6S):S81-S88. doi: 10.1016/j.jadohealth.2020.03.013.
- Background: PubMed 21257344Gradisar M, Gardner G, Dohnt H. Recent worldwide sleep patterns and problems during adolescence: a review and meta-analysis of age, region, and sleep. Sleep Med. 2011 Feb;12(2):110-8. doi: 10.1016/j.sleep.2010.11.008. Epub 2011 Jan 22.
- Individual participant dataSharing planned: No
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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.
Birna Baldursdottir, PhD principal investigator
Reykjavik University
Heiddis B. Valdimarsdottir, PhD study chair
Reykjavik University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BWL classrooms (Experimental) and DWL classrooms (Comparison) in people with Sleep Disturbance and Depression, run by Reykjavik University at 1 site in Iceland.
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 4 inclusion and 3 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 16 Apr 2024. 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 Iceland. 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. Some participants in this study may receive a placebo. 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?
ActTrust: Sleep/wake activity (time frame: Up to 9 months). The study lists 14 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 NCT05555186, which also lists 6 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 16 Apr 2024.