A Study on the Changes of the Biological Rhythm by Display Image Modulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Changes of serum melatonin
研究概览
简要总结
Effects of Smartphone Use at Night with Light Emitting Diode Display With and Without Blue Light in Healthy Adults: A Randomized, Double-blind, Cross-over, Placebo-controlled Comparison
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •(1) Healthy males 20-40 years of age who understood the study procedure and agreed to participate after being fully informed about the study were included.
排除标准
- •psychiatric diseases according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria;15
- •cognitive or neurological disorders;
- •alcohol or substance abuse;
- •unstable or serious medical illness;
- •current use of psychoactive mediations including antidepressants, anxiolytics, neuroleptics, anticonvulsants, hypnotics, or stimulant medications;
- •primary sleep disorder;
- •habitual sleep onset earlier than 21:00 or later than 24:00;
- •shift worker;
- •travel across more than two time zones within 90 days of the study; and
- •ophthalmologic disease during the study period.
研究组 & 干预措施
LED with bluelight
Two types of smartphone were used. One type had a conventional LED display with the full range of blue light. The LED in the other type newly developed by Samsung Display was suppressed for the blue light portion of the spectrum (wavelength 450 ~ 470 nm). The smartphones were indistinguishable from each other with the naked eye, because other wavelengths mimicked blue light in the suppressed LED.
干预措施: smartphone display (Device)
LED without bluelight
Two types of smartphone were used. One type had a conventional LED display with the full range of blue light. The LED in the other type newly developed by Samsung Display was suppressed for the blue light portion of the spectrum (wavelength 450 ~ 470 nm). The smartphones were indistinguishable from each other with the naked eye, because other wavelengths mimicked blue light in the suppressed LED.
干预措施: smartphone display (Device)
结局指标
主要结局
Changes of serum melatonin
时间窗: serum melatonin levels were measured every 60 min from 7:00 PM on day 1 to 8:00 AM on day 2, from 7:00 PM on day 2 to 8:00 AM on day 3, and from 7:00 PM to 11:00 PM on day 3 for 3 days.
Changes of serum cortisol
时间窗: cortisol levels were measured every 120 min from 7:00 PM on day 1 to 8:00 AM on day 2, from 7:00 PM on day 2 to 8:00 AM on day 3, and from 7:00 PM to 11:00 PM on day 3 for 3 days.
Changes of body temperature
时间窗: body temperature was measured every 120 min from 7:00 PM on day 1 to 8:00 AM on day 2, from 7:00 PM on day 2 to 8:00 AM on day 3, and from 7:00 PM to 11:00 PM on day 3 for 3days.
次要结局
- profile of mood states(POMS)(day 1,3)
- Epworth Sleepiness Scale(ESS)(day 1,3)
- Fatigue severity scale(FSS)(day 1,3)
- continuous performance test(CPT)(day1,3)