Passive Phototherapy to Improve Sleep in Teens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Total sleep time
研究概览
简要总结
The goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. The main questions this trial aims to answer are whether this combination therapy is able to meaningfully increase total sleep time in adolescents, and do so over a sustained period of time, and whether such a changes is associated with concomitant changes in mood and cognitive performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 14-18 and a full-time student in grades 9-12
- •Male or female
- •Willing and with a schedule permitting them to go to bed at an earlier time
- •Planning on sleeping at home in their bedroom for at least 75% of the study
排除标准
- •Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders
- •Sleep only in the prone (face-down) position
研究组 & 干预措施
Light + Cognitive Behavioral Therapy (CBT)
1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
干预措施: Light (Device)
Light + Cognitive Behavioral Therapy (CBT)
1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
干预措施: CBT (Behavioral)
Sham light + CBT
1 hour of sham light flashes (one flash) and cognitive behavioral therapy
干预措施: CBT (Behavioral)
Sham light + CBT
1 hour of sham light flashes (one flash) and cognitive behavioral therapy
干预措施: Sham Light (Device)
结局指标
主要结局
Total sleep time
时间窗: 20 weeks
Average nightly total sleep time
次要结局
- Melatonin timing(8 weeks)
- Mood(20 weeks)
研究者
Jamie M. Zeitzer, Ph.D.
Professor
Stanford University