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临床试验/NCT02957383
NCT02957383已完成不适用

Evning Exposure to Computer Screen Disrupts Sleep, Attention and Biological Rhythms

Assuta Medical Center0 个研究点目标入组 19 人开始时间: 2015年7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
19
主要终点
Karolinska Sleep Questionnaire (KSS)-Subjective sleepiness

研究概览

简要总结

Light exposure is on the rise in recent years. In large part because of unintentional illumination from screens that emit light directly into the eyes. Millions of computers, tablets, televisions, and smart-phones are sold worldwide every month and the usage time of these devices is increasing constantly. Today, people are exposed to ongoing light exposure from these device screens, emitting short wave length (SWL) during day and night hours, whether as active or passive users. In sum, artificial light at night (ALAN) seem to affect human circadian rhythmicity (melatonin and thermoregulation) and sleep, with two major factors. First, wavelength of light, with SWL being most detrimental to sleep and rhythms, when compared to LWL (Brianard et al., 2001). Second, a dose-response relationship exists between increasing light intensity and poorer sleep/circadian rhythms (Brianard et al., 1988; West et al., 2011).

Based on existing knowledge, we hypothesize that when compared to long wavelength LWL illumination, short wavelength SWL illumination from computer screen will have a more damaging effect on melatonin (MLT) production and secretion, interfering body temperature regulation and affecting sleep quality, efficiency and sleep architecture. In addition, we hypothesized that intensity of the screen illumination will play another important factor on these outcomes, we assume that high intensity compared to low intensity will have more damaging effect on: melatonin, thermoregulation and sleep.

详细描述

Methods:

Participants Participants were between the ages of 20 and 45 years, with BMI 18-25, regular sleep habits in Pittsburgh Sleep Quality Index (PSQI) questionnaire index<5 (Buysse et al., 1989, Shochat et al., 2007), and a normative sleep-wake cycle type (Horne-Ostberg morningness-eveningness questionnaire (Horne & Ostberg, 1976, Lavie & Segal, 1990) measured Sleep quality and continuity were measured for one week using actigraphy with compatible decoding software (Respironics Model II, Philips, Inc). Only participants with 6-8 hours of sleep, normative sleep patterns, and no sleep/wake schedule problems proceeded to the experimental phase of the study stage. Participants were healthy with no history of medical, neurological, sleep disorders (confirmed by polysomnography) or psychiatric conditions and no medication intake (excluding contraceptives for female participants). Participants with ocular damage, such as to their field of vision, color blindness, or impaired functioning of the pupil in reaction to light were excluded, however use of eyeglasses or contact lenses to correct vision was allowed. Participants signed informed consent prior to participation in the study. The study was approved by the Helsinki Committee of Assuta Medical Center and Maccabi Health Services.

Measurements

Three physiological measures were collected in the study:

Polysomnography: The sleep testing room was a standard test room at the Sleep Medicine Research Center at Assuta Medical Center. Standard in-lab polysomnography was conducted using the Somnoscreen-polysomnography (PSG) type sleeping test instrument (Somnomedics, Germany). Sleep channels included: electroencephalography (EEG), electro-oculography (EOG), leg and chin electromyography (EMG), nasal breathing, chest breathing, diaphragm breath, snoring, electro-cardio-graphy (EKG), heart rate, blood oxygen saturation, and body position. Sleep data processing was performed by skilled and trained sleep technicians in accordance with of the Rechtschaffen and Kales criteria (1968). Sleep continuity parameters: latency to stage 1 (SL1) and stage 2 (SL2), percent wake after sleep onset (%WASO), index of awakenings, total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Sleep architecture parameters: percent stage 1 (%S1), stage 2 (%S2), REM (%REM), and SWS (%SWS), index of sleep stage changes and REM onset latency (ROL).

研究设计

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

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •regular sleep habits in Pittsburgh Sleep Quality Index (PSQI) questionnaire index<5 normative sleep-wake cycle type (Horne-Ostberg morningness-eveningness questionnaire) 6-8 hours of sleep, normative sleep patterns, and no sleep/wake schedule.

排除标准

  • •participants with ocular damage, such as to their field of vision, color blindness, or impaired functioning of the pupil in reaction to light were excluded.

研究组 & 干预措施

intensity

Experimental

Luminance at two levels: low - 80 lux (35mw/cm2) and high - 350 lux (160mw/cm2).

干预措施: Intensity (Other)

wavelength

Experimental

Wavelength at two levels: short (SWL)-485 nm (13500k) and long (LWL)-620 nm (4250k)

干预措施: Wavelength (Other)

wavelength

Experimental

Wavelength at two levels: short (SWL)-485 nm (13500k) and long (LWL)-620 nm (4250k)

干预措施: Intensity (Other)

intensity

Experimental

Luminance at two levels: low - 80 lux (35mw/cm2) and high - 350 lux (160mw/cm2).

干预措施: Wavelength (Other)

结局指标

主要结局

Karolinska Sleep Questionnaire (KSS)-Subjective sleepiness

时间窗: 1 day

KSS questionaire - number

Epworth Sleepiness Scale (ESS) questionire- Sleepiness

时间窗: 1 day

Epworth Sleepiness Scale (ESS) questionire score- Number

Brief Symptom Inventory (BSI)- questionaire

时间窗: 1 day

Assess the subjects emotional state- number

Attention

时间窗: 1hour

continuous performance test (CPT-III) a computerized attention and concentration test. number

Stage 1% TIB

时间窗: 1 night

Percentage of sleep stage 1 from time in bed, physiological marker

Stage 2% TIB

时间窗: 1 night

Percentage of sleep stage 2 from time in bed, physiological marker

Body temperature

时间窗: 12 hours

Oral body temperature, physiological marker

Total Sleep Time

时间窗: 1 night

Total sleep time in minute. physiological marker

sleep efficiency

时间窗: 1 night

Percentage of sleep efficiency , physiological marker

Wake% TIB

时间窗: 1 night

Percentage of wake from time in bed, physiological marker

Melatonin secretion

时间窗: 12 hours

Melatonin - Sulfate Urine ELISA 6-SMT ng/ml, physiological marker

Sleep latency to stage 2

时间窗: 1 night

Tine in minute to sleep stage 2, physiological marker

Sleep latency to stage 1

时间窗: 1 night

Tine in minute to sleep stage 1, physiological marker

SWS% TIB

时间窗: 1 night

Percentage of sleep stage SWS from time in bed, physiological marker

次要结局

未报告次要终点

研究者

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

Lilach Kemer

Dr. Lilach Kemer

Assuta Medical Center

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