NCT02839395

Brief Summary

The human eye has a dual role, which is reflected by the various photo-receptors used for vision of images and colors ,Image forming photoreceptors (IFP) and for entrainment of our "Biological clock" located in the hypothalamus through the retinal ganglions known as non-image forming photoreceptors (NIFP). The recently discovered new photo-pigment melanopsin which is sensitive to short wavelength (SWL) illumination exists in the-NIFP. The axons of the NIFP form a special nerve known as the Retino-hypothalamic-tract (RHT) that transfers the SWL signal to the biological clock resulting in suppression of pineal melatonin (MLT) production. This is the basic mechanism by which environmental light/dark cycles entrain the biological clock and transfer the message to organs, tissues and cell. The American Medical Association (AMA) issued a resolution in 2012 stating that light at night constitutes environmental pollution because it violates the daily cycles, including the waking and sleeping cycles, and suppresses the secretion of melatonin from the pineal gland at night. Results of other studies have shown that exposure to artificial light at night (ALAN) and mainly those emerging from SWL sources suppresses MLT-produced in the pineal gland. Computers, tablets, TVs, and smart-phones screens emit SWL illumination, during the day and night hours, whether as active or passive users. The results of previous studies show that, exposure to SWL-ALAN illumination suppresses MLT-secretion and disrupts sleep patterns. In order to understand better the effect of SWL-exposure emerging from screens on human behavior and health, the investigators will study the effects of SWL-exposure on the structure and quality of sleep, cognitive functioning in Continous Performance Test (CPT III), emotional state, and physiological, variables (melatonin secretion levels and body temperature) that were not tested in previous studies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

July 7, 2016

Last Update Submit

January 8, 2018

Conditions

Keywords

screen illuminationmelatoninbody temperaturecognitive functioninglight pollution

Outcome Measures

Primary Outcomes (15)

  • body temperature

    body temperature in celsius degree.physiological marker

    12 hours

  • Melatonin secretion

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

    12 hours

  • sleepiness

    ESS questionnaire score- number

    1 day

  • BSI Questionnaire

    assess the subject's emotional state- number

    1 day

  • Subjective sleepiness

    KSS questionnaire-number

    1 day

  • attention

    a neuropsychological computerized attention and concentration test, designed to test attentional functions. number

    1 hour

  • total Sleep time

    total sleep time in minutes. physiological marker

    1 night

  • Sleep efficiency

    percentage of sleep efficiency- physiological marker

    1 night

  • sleep latency to sleep stage1

    time in minute to sleep stage 1. physiological marker

    1 night

  • sleep latency to sleep stage2

    time in minute to sleep stage 2. physiological marker

    1 night

  • wake %TIB

    percentage of wake from Time in bed. physiological marker

    1 night

  • REM %TIB

    percentage of REM from Time in bed. physiological marker

    1 night

  • staege1%TIB

    percentage of sleep stage1 from Time in bed. physiological marker

    1 night

  • stage2%TIB

    percentage of sleep stage2 from Time in bed.physiological marker

    1 night

  • stage4%TIB

    percentage of sleep stage4 from Time in bed.physiological marker

    1 night

Study Arms (3)

base line

ACTIVE COMPARATOR

First night is the base line- no exposure to computer screen illumination.

Other: No intervention- base line

Acute

EXPERIMENTAL

Second night is the acute exposure to computer screen illumination.

Other: Acute

Chronic

EXPERIMENTAL

Chronic is the effect after five nights of exposure to computer screen light illumination.

Other: Chronic

Interventions

the subject will sited in a dim light room. No screen light illumination.

base line
AcuteOTHER

The subject will be sited in front of computer screen light illumination for 2 hours.

Acute
ChronicOTHER

The subject will be sited in front of computer screen light illumination for 2 hours for 5 consecutive days.

Chronic

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 20-45,
  • healthy
  • No history of visual disturbances
  • No history of sleep disorders

You may not qualify if:

  • score more then 5 in the Pittsburgh Questionnaire (PSQI).
  • Subjects with a-typicality deviation in the HORNE - OSTBERG sleep-wakefulness cycle questionnaire.
  • One of the Eye problems: field of vision, color blindness, or impaired functioning of the pupil in reaction to light.
  • Subjects who did shiftwork three months before the experiment
  • Subjects that taking sleeping medications in general and melatonin in particular

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 21, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share