Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Objective Sleep Duration During Melatonin Administration
研究概览
简要总结
The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
- •Ages 13 to 17 years old
- •Able to understand, read, and write in English
- •Melatonin naive
排除标准
- •Use of psychiatric medication
- •Drug(s), or supplements known to affect sleep
- •History of head injury or concussion with loss of consciousness >1 minute
- •Daily consumption of >1 caffeinated beverage
- •Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)
研究组 & 干预措施
Administration of Placebo
干预措施: Placebo (Other)
Administration of Melatonin
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
Change in Objective Sleep Duration During Melatonin Administration
时间窗: Change between baseline and two weeks
Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving melatonin (14 nights/2 weeks total). Changes in objective sleep duration would be demonstrated by either an increase or decrease in number of hours asleep compared to baseline
Change in Objective Sleep Duration During Placebo Administration
时间窗: Change between baseline and two weeks
Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving placebo (14 nights/2 weeks total). No change in objective sleep duration would be demonstrated compared to baseline
次要结局
- Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)(Change between baseline and two weeks)
- Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)(Change between baseline and two weeks)