Sleepiness, DaytimeLiteBookNCT05383690
Effects of Litebook EDGE™ Phototherapy on Academic Performance and Brain Activity
A study testing LED bright light treatment device in people with Sleepiness, Daytime, run by Mclean Hospital at 1 site in United States.
Trial summary
As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late. High school typically starts early in the morning and a significant percentage of normal adolescents arrive at school each day with an insufficient amount of sleep, which can take… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleepiness, Daytime
- What is being tested?
- LED bright light treatment device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2017to 23 Jun 2017
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in school, drowsiness/sleepiness during morning classes which interferes to some degree with academic performance but able to wake up and be on time for said classes, willingness to use a device in the morning to enhance alertness, Intelligence Quotient greater than 80
Who cannot join
- Symptoms of psychiatric disorder on screening, current use of medications, home schooled, involved in morning activities, like athletics, that can alter morning alertness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Litebook EDGE™ Phototherapy on Academic Performance and Functional Brain Activity in Non-Depressed Adolescents
As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late. High school typically starts early in the morning and a significant percentage of normal adolescents arrive at school each day with an insufficient amount of sleep, which can take a substantial toll on their academic performance. As the primary reason for insufficient sleep is a naturally occurring propensity to stay up later in the evening it seems plausible that bright light treatment (BLT) at the appropriate time may phase advance biological clocks and potentially reverse this problem. Hence, the investigators are testing the hypothesis that consistent morning use of a light emitting diode (LED) BLT device (LiteBook Edge™) by healthy adolescents will shift the phase of their sleep wake cycle and enable them to receive an increased amount of sleep during the school week and perform better on tests of attention and academic performance and evidence signs of improved alertness. Alternatively, BLT could potentially enhance alertness through other mechanisms, such as a direct arousing effect, without exerting a discernible effect on circadian phase or sleep duration.
Read the detailed description
As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late. Hence, a large percentage of normal adolescents arrive at school each day with an insufficient amount of sleep, which can take a substantial toll on their academic performance.
A growing number of human studies show that sleep promotes learning and memory. Conversely, sleep deprivation has a negative impact on cognitive and behavioral functions. Relatively few studies have examined effects of sleep deprivation on cognitive performance in adolescents. In these studies, total sleep deprivation was associated with impaired memory performance and diminished computational speed, while, partial sleep deprivation was associated with deficits in reasoning and verbal creativity. For example, male adolescents sleeping more than 8 hours per day had significantly higher reasoning ability than their peers who slept for less than 8 hours per day. Some studies reported that simpler cognitive processes such as working memory and computational speed may not be significantly affected by a single night of sleep limited to 4 to 5 hours. However, even mild sleep restriction of an hour or more, when persistent across days, can lead to memory problems as severe as seen following total sleep deprivation.
The sensitivity of the adolescent brain to subtle sleep impairments was highlighted in a study where 12-14-year-olds were allowed to play stimulating computer games or watch television right before bedtime. This experience prolonged sleep latency, increased stage 2 sleep and reduced slow wave sleep. This modest degree of sleep restriction significantly impaired verbal memory consolidation Suboptimal sleep duration in adolescents was also associated with poor performance on a serial digit-learning test during morning testing sessions, but not in afternoon sessions. Between 58-68% of high school students surveyed in Ontario report that they feel "really sleepy" between 8 and 10 A.M. Thus, achievement in early morning classes may suffer the most in sleep-deprived adolescents.
Fortunately, sleep only needs to be extended by a modest amount to enhance cognition in children. Sadeh showed that performance on memory, attention and vigilance tasks in children improved significantly after 1 hour of sleep extension on three consecutive nights. Gais and Backhaus have also shown the beneficial effects of sleep on memory consolidation in children and adolescents.
Overall, there is compelling scientific evidence that schoolchildren, particularly adolescents, are chronically sleep deprived, that the degree of sleep restriction they experience exerts demonstrable effects on memory encoding, consolidation and processing speed, and that even a modest increase in sleep will result in measurable improvements in cognitive function. The primary reason that adolescents are sleep deprived is due to a naturally occurring phase delay in their biological clock, resulting in a propensity to stay up until late in the evening which is incompatible with the early rise times schools typically require. Light treatments at the appropriate time can phase advance the biological clock, potentially reversing this problem.
The hypothesis that the investigators propose to test is that consistent morning use of the Litebook Edge™ bright light therapy device, coupled with two-hour pre-bedtime use of blue-wave light blocking glasses while watching video screens will shift the circadian phase of the sleep-wake cycle of normal adolescents. This in turn will enable them to fall asleep earlier and to receive an increased amount of sleep during the school week. Consequently, they will awaken more readily, feel more awake during early classes, and will perform better on tests of academic performance, attention and working memory. Light therapy will enhance functional connectivity of prefrontal regions involved in attention. Degree of improvement in cognition, attention and functional and structural MRI measures will be directly related to average time spent each day activating (and presumably using) the device, which will be the independent variable in the statistical analyses.
This is a one-arm study, and all participants will receive active treatment. The device was designed to monitor degree of use and the primary statistical question is whether there is a significant association between degree of use and improvement in measures of wakefulness, alertness, and cognitive performance.
This approach of using duration of device activation as the independent variable, in a small preliminary study, provides several advantages over a two-arm studying comparing bright white light to either placebo red light or another type of mechanical device. First, effect size measures previously calculated assumed that subjects in both groups would use the device. There will likely be significant variability between subjects in degree of use and if only a fraction of subjects assigned the bright light device used it consistently then the overall impact would be weaker and possibly missed in a two-group analysis. Using duration of device operation will enable the investigators to compare subjects who used it to a considerable degree versus subjects who hardly use it at all and would likely provide a good estimate of how much benefit accrues from different degrees of use.
This is particularly important for the neuroimaging component. If the investigators compared active versus placebo devices, then only half of the neuroimaged subjects would receive the active device, which may leave the investigators comparing pre versus post effects in only 8-10 subjects. In this revised design all the neuroimaged sample (n = 16-20) would receive the active treatment making the pre-post comparisons stronger, especially when adjusted for duration of device activation.
Second, using duration of device activation as the independent variable will markedly facilitate recruitment. If the investigators used a placebo device, they would need to indicate in the informed consent that subjects may receive a placebo device, without revealing what the placebo is. Instead, the investigators can now indicate in the informed consent that all subjects will receive a device that they believe is biologically active and that no placebos will be used.
This also makes the protocol simpler as raters do not need to be kept blind to device type. All the investigators need to do is make sure that raters remain unaware of duration of device activation.
- Conditions
- Sleepiness, Daytime
- Being tested
- LED bright light treatment device
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED bright light treatment deviceDevice
Also called LiteBook Edge™
Subjects will be instructed to use the bright light treatment device, as early as possible, for 30 minutes each morning. These devices will be equipped with monitoring electronics that will enable us to download their daily degree of use. Participants will also be provided with yellow-tinted blue light blocking glasses and will be instructed to wear them starting 2 hours before bedtime if they are viewing LED or liquid-crystal display screens.
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Arm | Experimental | This is a one-arm study. Subjects will be provided with the LiteBook Edge™ (LiteBook Company LTD), which is a patented smart phone sized BLT device that provides 10,000 lux illumination at a recommended distance of 61 cm from an LED panel with peak spectral radiance in the blue color spectrum that closely corresponds to the peak spectral frequency (480 nm) of melanopsin photoreceptors that project to the suprachiasmatic nucleus and entrain the circadian clock (Hatori \& Panda, 2010). Receives: Device: LED bright light treatment device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta electroencephalographic (EEG) activity
Primary outcome measure one is the degree of increase in beta EEG activity, which is indicative of wakefulness and arousal. Change in beta EEG power will be compared to degree of use of the bright light treatment device.
Measured: Baseline and week 4 (or last observation after baseline)
Theta electroencephalographic (EEG) activity
Primary outcome measure two is the degree of decease in theta EEG activity, which is indicative of drowsiness. Change in theta EEG power will be compared to degree of use of the bright light treatment device.
Measured: Baseline and week 4 (or last observation after baseline)
Sleep onset
Primary outcome measure three is the change in actigraph-assessed sleep onset to an earlier hour. Change in sleep onset time will be compared to degree of use of the bright light treatment device.
Measured: Baseline and week 4 (or last observation after baseline)
Sleep duration
Primary outcome measure four is the increase in actigraph-assessed sleep duration. Change in sleep duration will be compared to degree of use of the bright light treatment device.
Measured: Baseline and week 4 (or last observation after baseline)
Secondary outcomes (6)
Errors of omission
Errors of omission on the Quotient ADHD System provides a measure of inattention. These errors occur when a subject fails to respond to a target stimulus. Degree of reduction in errors of omission will be compared to degree of use of the bright light treatment device.
Measured: Baseline and week 4 (or last observation after baseline)
Response variability
Variability in response speed on the Quotient ADHD System to target stimuli provides another measure of inattention. Degree of reduction in response variability will be compared to degree of use of the bright light treatment device.
Measured: Baseline and week 4 (or last observation after baseline)
Mathematical ability
Participants will be tested on their ability to correctly solve as many complex math problems from high school placement exam as they can in 10 minutes. Degree of improvement will be compared to degree of use of the bright light treatment device.
Measured: Baseline and week 4 (or last observation after baseline)
Simple computational speed
Fifty single digit addition and subtraction problems will be presented to participants using the Modified Walter Reed serial addition/subtraction task to assess computational speed. Degree of improvement will be compared to degree of use of the bright light treatment device.
Measured: Baseline and week 4 (or last observation after baseline)
Dentate gyrus volume
The volume of the dentate gyrus, a portion of the hippocampal complex in the brain will be measured using magnetic resonance imaging. This brain region is involved in memory processes and can change in size in response to stress and sleep deprivation. Increase in dentate gyrus volume will be compared to degree of use of the bright light treatment device.
Measured: Baseline and week 4 (or last observation after baseline)
Sleep propensity
Self-reported change in propensity to fall asleep in various situations will be assessed using the Epworth Sleepiness Scale. Degree of reduction in sleep propensity will be compared to degree of use of the bright light treatment.
Measured: Baseline and week 4 (or last observation after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start27 Mar 2017
- Primary completion23 Jun 2017
- Study completion23 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Sleepiness, DaytimeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, with independent variable being percent device use.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LiteBook Company Ltd
- Responsible party
- Principal investigator, Martin H Teicher, Mclean Hospital
- Investigators
- Martin H Teicher, MD,PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383690
- Sponsor's protocol ID
- 2016D003724
- Acronym
- LiteBook
- Status last verified
- May 2022
- First submitted
- 8 May 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Backhaus J, Hoeckesfeld R, Born J, Hohagen F, Junghanns K. Immediate as well as delayed post learning sleep but not wakefulness enhances declarative memory consolidation in children. Neurobiol Learn Mem. 2008 Jan;89(1):76-80. doi: 10.1016/j.nlm.2007.08.010. Epub 2007 Oct 29.
PubMed 17911036Banks S, Dinges DF. Behavioral and physiological consequences of sleep restriction. J Clin Sleep Med. 2007 Aug 15;3(5):519-28.
PubMed 17803017Born J, Rasch B, Gais S. Sleep to remember. Neuroscientist. 2006 Oct;12(5):410-24. doi: 10.1177/1073858406292647.
PubMed 16957003Born J, Wagner U. Sleep, hormones, and memory. Obstet Gynecol Clin North Am. 2009 Dec;36(4):809-29, x. doi: 10.1016/j.ogc.2009.10.001.
PubMed 19944302Cajochen C. Alerting effects of light. Sleep Med Rev. 2007 Dec;11(6):453-64. doi: 10.1016/j.smrv.2007.07.009. Epub 2007 Nov 1.
PubMed 17936041Carskadon MA, Acebo C, Jenni OG. Regulation of adolescent sleep: implications for behavior. Ann N Y Acad Sci. 2004 Jun;1021:276-91. doi: 10.1196/annals.1308.032.
PubMed 15251897Carskadon MA, Harvey K, Dement WC. Sleep loss in young adolescents. Sleep. 1981 Sep;4(3):299-312. doi: 10.1093/sleep/4.3.299.
PubMed 7302461Carvalho-Mendes RP, Dunster GP, de la Iglesia HO, Menna-Barreto L. Afternoon School Start Times Are Associated with a Lack of Both Social Jetlag and Sleep Deprivation in Adolescents. J Biol Rhythms. 2020 Aug;35(4):377-390. doi: 10.1177/0748730420927603. Epub 2020 Jun 8.
PubMed 32508224Crowley SJ, Acebo C, Carskadon MA. Sleep, circadian rhythms, and delayed phase in adolescence. Sleep Med. 2007 Sep;8(6):602-12. doi: 10.1016/j.sleep.2006.12.002. Epub 2007 Mar 26.
PubMed 17383934Curcio G, Ferrara M, De Gennaro L. Sleep loss, learning capacity and academic performance. Sleep Med Rev. 2006 Oct;10(5):323-37. doi: 10.1016/j.smrv.2005.11.001. Epub 2006 Mar 24.
PubMed 16564189Dewald JF, Meijer AM, Oort FJ, Kerkhof GA, Bogels SM. The influence of sleep quality, sleep duration and sleepiness on school performance in children and adolescents: A meta-analytic review. Sleep Med Rev. 2010 Jun;14(3):179-89. doi: 10.1016/j.smrv.2009.10.004. Epub 2010 Jan 21.
PubMed 20093054Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4.
PubMed 20046194Dijk DJ, Beersma DG, Daan S, Lewy AJ. Bright morning light advances the human circadian system without affecting NREM sleep homeostasis. Am J Physiol. 1989 Jan;256(1 Pt 2):R106-11. doi: 10.1152/ajpregu.1989.256.1.R106.
PubMed 2912203Durmer JS, Dinges DF; New Collective Author. Neurocognitive consequences of sleep deprivation. Semin Neurol. 2005 Mar;25(1):117-29. doi: 10.1055/s-2005-867080.
PubMed 15798944Dworak M, Schierl T, Bruns T, Struder HK. Impact of singular excessive computer game and television exposure on sleep patterns and memory performance of school-aged children. Pediatrics. 2007 Nov;120(5):978-85. doi: 10.1542/peds.2007-0476.
PubMed 17974734
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Litebook EDGE™ Phototherapy on Academic Performance and Functional Brain Activity in Non-Depressed Adolescents
- ClinicalTrials.gov ID
- NCT05383690
- Acronym / sponsor ID
- LiteBook / 2016D003724
- Conditions
- Sleepiness, Daytime
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- LiteBook Company Ltd
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 20 May 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.
As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late. High school typically starts early in the morning and a significant percentage of normal adolescents arrive at school each day with an insufficient amount of sleep, which can take a substantial toll on their academic performance. As the primary reason for insufficient sleep is a naturally occurring propensity to stay up later in the evening it seems plausible that bright light treatment (BLT) at the appropriate time may phase advance biological clocks and potentially reverse this problem. Hence, the investigators are testing the hypothesis that consistent morning use of a light emitting diode (LED) BLT device (LiteBook Edge™) by healthy adolescents will shift the phase of their sleep wake cycle and enable them to receive an increased amount of sleep during the school week and perform better on tests of attention and academic performance and evidence signs of improved alertness. Alternatively, BLT could potentially enhance alertness through other mechanisms, such as a direct arousing effect, without exerting a discernible effect on circadian phase or sleep duration.
Detailed description
As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late. Hence, a large percentage of normal adolescents arrive at school each day with an insufficient amount of sleep, which can take a substantial toll on their academic performance.
A growing number of human studies show that sleep promotes learning and memory. Conversely, sleep deprivation has a negative impact on cognitive and behavioral functions. Relatively few studies have examined effects of sleep deprivation on cognitive performance in adolescents. In these studies, total sleep deprivation was associated with impaired memory performance and diminished computational speed, while, partial sleep deprivation was associated with deficits in reasoning and verbal creativity. For example, male adolescents sleeping more than 8 hours per day had significantly higher reasoning ability than their peers who slept for less than 8 hours per day. Some studies reported that simpler cognitive processes such as working memory and computational speed may not be significantly affected by a single night of sleep limited to 4 to 5 hours. However, even mild sleep restriction of an hour or more, when persistent across days, can lead to memory problems as severe as seen following total sleep deprivation.
The sensitivity of the adolescent brain to subtle sleep impairments was highlighted in a study where 12-14-year-olds were allowed to play stimulating computer games or watch television right before bedtime. This experience prolonged sleep latency, increased stage 2 sleep and reduced slow wave sleep. This modest degree of sleep restriction significantly impaired verbal memory consolidation Suboptimal sleep duration in adolescents was also associated with poor performance on a serial digit-learning test during morning testing sessions, but not in afternoon sessions. Between 58-68% of high school students surveyed in Ontario report that they feel "really sleepy" between 8 and 10 A.M. Thus, achievement in early morning classes may suffer the most in sleep-deprived adolescents.
Fortunately, sleep only needs to be extended by a modest amount to enhance cognition in children. Sadeh showed that performance on memory, attention and vigilance tasks in children improved significantly after 1 hour of sleep extension on three consecutive nights. Gais and Backhaus have also shown the beneficial effects of sleep on memory consolidation in children and adolescents.
Overall, there is compelling scientific evidence that schoolchildren, particularly adolescents, are chronically sleep deprived, that the degree of sleep restriction they experience exerts demonstrable effects on memory encoding, consolidation and processing speed, and that even a modest increase in sleep will result in measurable improvements in cognitive function. The primary reason that adolescents are sleep deprived is due to a naturally occurring phase delay in their biological clock, resulting in a propensity to stay up until late in the evening which is incompatible with the early rise times schools typically require. Light treatments at the appropriate time can phase advance the biological clock, potentially reversing this problem.
The hypothesis that the investigators propose to test is that consistent morning use of the Litebook Edge™ bright light therapy device, coupled with two-hour pre-bedtime use of blue-wave light blocking glasses while watching video screens will shift the circadian phase of the sleep-wake cycle of normal adolescents. This in turn will enable them to fall asleep earlier and to receive an increased amount of sleep during the school week. Consequently, they will awaken more readily, feel more awake during early classes, and will perform better on tests of academic performance, attention and working memory. Light therapy will enhance functional connectivity of prefrontal regions involved in attention. Degree of improvement in cognition, attention and functional and structural MRI measures will be directly related to average time spent each day activating (and presumably using) the device, which will be the independent variable in the statistical analyses.
This is a one-arm study, and all participants will receive active treatment. The device was designed to monitor degree of use and the primary statistical question is whether there is a significant association between degree of use and improvement in measures of wakefulness, alertness, and cognitive performance.
This approach of using duration of device activation as the independent variable, in a small preliminary study, provides several advantages over a two-arm studying comparing bright white light to either placebo red light or another type of mechanical device. First, effect size measures previously calculated assumed that subjects in both groups would use the device. There will likely be significant variability between subjects in degree of use and if only a fraction of subjects assigned the bright light device used it consistently then the overall impact would be weaker and possibly missed in a two-group analysis. Using duration of device operation will enable the investigators to compare subjects who used it to a considerable degree versus subjects who hardly use it at all and would likely provide a good estimate of how much benefit accrues from different degrees of use.
This is particularly important for the neuroimaging component. If the investigators compared active versus placebo devices, then only half of the neuroimaged subjects would receive the active device, which may leave the investigators comparing pre versus post effects in only 8-10 subjects. In this revised design all the neuroimaged sample (n = 16-20) would receive the active treatment making the pre-post comparisons stronger, especially when adjusted for duration of device activation.
Second, using duration of device activation as the independent variable will markedly facilitate recruitment. If the investigators used a placebo device, they would need to indicate in the informed consent that subjects may receive a placebo device, without revealing what the placebo is. Instead, the investigators can now indicate in the informed consent that all subjects will receive a device that they believe is biologically active and that no placebos will be used.
This also makes the protocol simpler as raters do not need to be kept blind to device type. All the investigators need to do is make sure that raters remain unaware of duration of device activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, with independent variable being percent device use.
| Arm | Type | Receives |
|---|---|---|
| Bright Light Arm | Experimental | Device: LED bright light treatment deviceThis is a one-arm study. Subjects will be provided with the LiteBook Edge™ (LiteBook Company LTD), which is a patented smart phone sized BLT device that provides 10,000 lux illumination at a recommended distance of 61 cm from an LED panel with peak spectral radiance in the blue color spectrum that closely corresponds to the peak spectral frequency (480 nm) of melanopsin photoreceptors that project to the suprachiasmatic nucleus and entrain the circadian clock (Hatori \& Panda, 2010). |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled in school, drowsiness/sleepiness during morning classes which interferes to some degree with academic performance but able to wake up and be on time for said classes, willingness to use a device in the morning to enhance alertness, Intelligence Quotient greater than 80
Key exclusion criteria (1 listed)
- Symptoms of psychiatric disorder on screening, current use of medications, home schooled, involved in morning activities, like athletics, that can alter morning alertness
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 |
|---|---|---|
| LED bright light treatment deviceAlso: LiteBook Edge™Subjects will be instructed to use the bright light treatment device, as early as possible, for 30 minutes each morning. These devices will be equipped with monitoring electronics that will enable us to download their daily degree of use. Participants will also be provided with yellow-tinted blue light blocking glasses and will be instructed to wear them starting 2 hours before bedtime if they are viewing LED or liquid-crystal display screens. | Device | Bright Light Arm |
Primary outcome
Beta electroencephalographic (EEG) activity
Time frame: Baseline and week 4 (or last observation after baseline)
Primary outcome measure one is the degree of increase in beta EEG activity, which is indicative of wakefulness and arousal. Change in beta EEG power will be compared to degree of use of the bright light treatment device.
Theta electroencephalographic (EEG) activity
Time frame: Baseline and week 4 (or last observation after baseline)
Primary outcome measure two is the degree of decease in theta EEG activity, which is indicative of drowsiness. Change in theta EEG power will be compared to degree of use of the bright light treatment device.
Sleep onset
Time frame: Baseline and week 4 (or last observation after baseline)
Primary outcome measure three is the change in actigraph-assessed sleep onset to an earlier hour. Change in sleep onset time will be compared to degree of use of the bright light treatment device.
Sleep duration
Time frame: Baseline and week 4 (or last observation after baseline)
Primary outcome measure four is the increase in actigraph-assessed sleep duration. Change in sleep duration will be compared to degree of use of the bright light treatment device.
6 secondary outcomes
Errors of omission
Time frame: Baseline and week 4 (or last observation after baseline)
Response variability
Time frame: Baseline and week 4 (or last observation after baseline)
Mathematical ability
Time frame: Baseline and week 4 (or last observation after baseline)
Simple computational speed
Time frame: Baseline and week 4 (or last observation after baseline)
Dentate gyrus volume
Time frame: Baseline and week 4 (or last observation after baseline)
Sleep propensity
Time frame: Baseline and week 4 (or last observation after baseline)
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 20 May 2022.
- Background: PubMed 17911036Backhaus J, Hoeckesfeld R, Born J, Hohagen F, Junghanns K. Immediate as well as delayed post learning sleep but not wakefulness enhances declarative memory consolidation in children. Neurobiol Learn Mem. 2008 Jan;89(1):76-80. doi: 10.1016/j.nlm.2007.08.010. Epub 2007 Oct 29.
- Background: PubMed 17803017Banks S, Dinges DF. Behavioral and physiological consequences of sleep restriction. J Clin Sleep Med. 2007 Aug 15;3(5):519-28.
- Background: PubMed 16957003Born J, Rasch B, Gais S. Sleep to remember. Neuroscientist. 2006 Oct;12(5):410-24. doi: 10.1177/1073858406292647.
- Background: PubMed 19944302Born J, Wagner U. Sleep, hormones, and memory. Obstet Gynecol Clin North Am. 2009 Dec;36(4):809-29, x. doi: 10.1016/j.ogc.2009.10.001.
- Background: PubMed 17936041Cajochen C. Alerting effects of light. Sleep Med Rev. 2007 Dec;11(6):453-64. doi: 10.1016/j.smrv.2007.07.009. Epub 2007 Nov 1.
- Background: PubMed 15251897Carskadon MA, Acebo C, Jenni OG. Regulation of adolescent sleep: implications for behavior. Ann N Y Acad Sci. 2004 Jun;1021:276-91. doi: 10.1196/annals.1308.032.
- Background: PubMed 7302461Carskadon MA, Harvey K, Dement WC. Sleep loss in young adolescents. Sleep. 1981 Sep;4(3):299-312. doi: 10.1093/sleep/4.3.299.
- Background: PubMed 32508224Carvalho-Mendes RP, Dunster GP, de la Iglesia HO, Menna-Barreto L. Afternoon School Start Times Are Associated with a Lack of Both Social Jetlag and Sleep Deprivation in Adolescents. J Biol Rhythms. 2020 Aug;35(4):377-390. doi: 10.1177/0748730420927603. Epub 2020 Jun 8.
- Background: PubMed 17383934Crowley SJ, Acebo C, Carskadon MA. Sleep, circadian rhythms, and delayed phase in adolescence. Sleep Med. 2007 Sep;8(6):602-12. doi: 10.1016/j.sleep.2006.12.002. Epub 2007 Mar 26.
- Background: PubMed 16564189Curcio G, Ferrara M, De Gennaro L. Sleep loss, learning capacity and academic performance. Sleep Med Rev. 2006 Oct;10(5):323-37. doi: 10.1016/j.smrv.2005.11.001. Epub 2006 Mar 24.
- Background: PubMed 20093054Dewald JF, Meijer AM, Oort FJ, Kerkhof GA, Bogels SM. The influence of sleep quality, sleep duration and sleepiness on school performance in children and adolescents: A meta-analytic review. Sleep Med Rev. 2010 Jun;14(3):179-89. doi: 10.1016/j.smrv.2009.10.004. Epub 2010 Jan 21.
- Background: PubMed 20046194Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4.
- Individual participant dataSharing planned: No
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Major Depressive Disorder (MDD)
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Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
RecruitingPhase 2/3
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1, Narcolepsy Type 2
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.
Martin H Teicher, MD,PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED bright light treatment device in people with Sleepiness, Daytime, run by Mclean Hospital at 1 site in United States.
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 1 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 20 May 2022. 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 United States. 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?
Beta electroencephalographic (EEG) activity (time frame: Baseline and week 4 (or last observation after baseline)). 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 NCT05383690, which also lists 37 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 20 May 2022.