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临床试验/NCT04828473
NCT04828473Unknown不适用

Green Light Effect on Sleep

The Green Light Study Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
1
主要终点
narrow band green light and sleep

研究概览

简要总结

The main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improved sleep quality in healthy subjects.

This is a within-subject study design that examines NBGL effects on sleep onset, sleep fractures (i.e., how many times per night the subjects wake up), total sleep duration, and sleep quality using high-resolution assessments. To complete the study, each participant will complete a 30-day, daily sleep diary while using white light (i.e., being in regular room light) during the last 2 hours of their waking period. This period will be defined as the baseline/control arm of the study. After completing this phase 1, subjects will receive a lamp designed to emit the narrow band of green light and again be asked to complete a 30-day, daily sleep diary, but this timer while using the NBGL light (i.e., being in what appears green light) during the last 2 hours of their waking period. This period will be defined as the active arm of the study. After completing this phase 2,

详细描述

Sleep quality will be assessed using the Consensus sleep diary [Carney et al., (2012)] The consensus sleep diary: Standardizing prospective sleep self-monitoring, Sleep Vol.35, No.2, pp.287-302], the latter of which captures total sleep time, sleep latency, wake after sleep onset, number of awakenings, quality, sleep efficiency, and trouble staying awake.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
40 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy volunteers who wish to improve their sleep quality

排除标准

  • •Subjects diagnosed with sleep disorders and are currently on medications and/or devices that aid their sleep ( eg trazadone as medication, CPAP)

结局指标

主要结局

narrow band green light and sleep

时间窗: 2 months

this primary outcome measures improvement in sleep quality during the month in which subjects used the green light as compared to the month in which they used the regular room light. Sleep quality will be measured by the Consensus Sleep Diary. THe Consensus Sleep Diary requires subjects to answer 8 questions by depicting numbers that represent best their answers. These numbers provide the basis for our ability to quantify the difference between the two light conditions of the study.

次要结局

未报告次要终点

研究者

发起方
The Green Light Study Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Hart

Primary Care Provider

The Green Light Study Center

研究点 (1)

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