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临床试验/NCT02483559
NCT02483559已完成不适用

Seeing the World Through Assorted Glasses (SWAG)

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Increase dim-light melatonin production

研究概览

简要总结

The purpose of the study is to test the use of amber glasses at night as a method to block blue light from the eye, allowing the brain to produce a dim-light melatonin onset. The investigators hypothesize that blue-blocking will produce measurable benefits in subjectively and objectively rated sleep quality and mood as well as salivary melatonin levels during the night.

详细描述

Participants will complete a self-report battery containing measures of sleep quality, morningness-eveningness chronotype, and mood. Participants will then wear a wrist-worn accelerometer for 14 days to objectively record activity level and sleep quality. Participants will also fill out a daily sleep log and short self-report measures assessing sleep and mood. On days 4-7 and 11-14 of the study the participants will wear either amber or placebo control lenses prior to sleep onset in a randomized crossover design (i.e., participants will be randomized to wear either amber lenses or placebo lenses for the first part of the protocol and then switch to wear the opposite lenses for the second part of the protocol). Participants will spend nights 7 and 14 of the study in a sleep laboratory in order to obtain hourly melatonin samples and wear a wrist sleep monitor to non-invasively and objectively measure sleep state and quality using peripheral arterial tone and oxygen perfusion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Good physical health
  • •Proficiency in written and spoken English
  • •Reported average total sleep time <9 hours (so nights spent in sleep lab will not result in sleep deprivation)

排除标准

  • •Taking regular medication affecting sleep and/or mood
  • •Travel across more than two time zones within the past month
  • •Smoke > 5 cigarettes per day
  • •Excessive caffeine use (>2 cups at one time or >500 mg daily)
  • •No current Axis I Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Disorder
  • •No current use of street drugs
  • •No history of sleep disorder/bipolar disorder/psychosis/seizure disorder/chronic medical condition
  • •Night shift work within the past 2 months

研究组 & 干预措施

Amber Lenses

Other

Participants will be randomized to participate in the amber lens condition first or second. Outcome measures to assess the effects of wearing amber lenses to block the blue light spectrum of light includes mood and sleep rating questionnaires (Positive and Negative Affect Scale, PANAS; Leeds Sleep Evaluation Questionnaire) as well as measuring the levels of melatonin the body is producing while wearing the glasses.

干预措施: Amber Lenses (Other)

Placebo Lenses

Other

Participants will be randomized to participate in the placebo lens condition first or second. Outcome measures to assess the effects of wearing placebo lenses to allow all spectrums of light includes mood and sleep rating questionnaires (Positive and Negative Affect Scale, PANAS; Leeds Sleep Evaluation Questionnaire) as well as measuring the levels of melatonin the body is producing while wearing the glasses.

干预措施: Placebo Lenses (Other)

结局指标

主要结局

Increase dim-light melatonin production

时间窗: 4 days

Hourly saliva samples will be collected from participants at the end of each 4 night interval in order to measure levels of melatonin production.

次要结局

  • Improved subjective self-reported mood(4 days)
  • Improved objective measures of sleep(4 days)
  • Improved subjective self-reported sleep quality(4 days)

研究者

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

Eric Youngstrom, PhD

Professor of Psychology and Psychiatry

University of North Carolina, Chapel Hill

研究点 (1)

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