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临床试验/NCT05383690
NCT05383690已完成不适用

Effects of Litebook EDGE™ Phototherapy on Academic Performance and Functional Brain Activity in Non-Depressed Adolescents

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Theta electroencephalographic (EEG) activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Symptoms of psychiatric disorder on screening, current use of medications, home schooled, involved in morning activities, like athletics, that can alter morning alertness

结局指标

主要结局

Theta electroencephalographic (EEG) activity

时间窗: 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 duration

时间窗: 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.

Sleep onset

时间窗: 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.

Beta electroencephalographic (EEG) activity

时间窗: 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.

次要结局

  • Mathematical ability(Baseline and week 4 (or last observation after baseline))
  • Dentate gyrus volume(Baseline and week 4 (or last observation after baseline))
  • Sleep propensity(Baseline and week 4 (or last observation after baseline))
  • Response variability(Baseline and week 4 (or last observation after baseline))
  • Errors of omission(Baseline and week 4 (or last observation after baseline))
  • Simple computational speed(Baseline and week 4 (or last observation after baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin H Teicher

Research Psychiatrist

Mclean Hospital

研究点 (2)

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