NCT02957383

Brief Summary

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.

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 Jul 2015

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

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

November 3, 2016

Last Update Submit

November 5, 2016

Conditions

Keywords

Sleep, MelatoninCircadian RhythmTemperaturescreen illumination

Outcome Measures

Primary Outcomes (14)

  • Body temperature

    Oral body temperature, physiological marker

    12 hours

  • Melatonin secretion

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

    12 hours

  • Epworth Sleepiness Scale (ESS) questionire- Sleepiness

    Epworth Sleepiness Scale (ESS) questionire score- Number

    1 day

  • Brief Symptom Inventory (BSI)- questionaire

    Assess the subjects emotional state- number

    1 day

  • Karolinska Sleep Questionnaire (KSS)-Subjective sleepiness

    KSS questionaire - number

    1 day

  • Attention

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

    1hour

  • Total Sleep Time

    Total sleep time in minute. physiological marker

    1 night

  • sleep efficiency

    Percentage of sleep efficiency , physiological marker

    1 night

  • Sleep latency to stage 1

    Tine in minute to sleep stage 1, physiological marker

    1 night

  • Sleep latency to stage 2

    Tine in minute to sleep stage 2, physiological marker

    1 night

  • Wake% TIB

    Percentage of wake from time in bed, physiological marker

    1 night

  • Stage 1% TIB

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

    1 night

  • Stage 2% TIB

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

    1 night

  • SWS% TIB

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

    1 night

Study Arms (2)

wavelength

EXPERIMENTAL

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

Other: WavelengthOther: Intensity

intensity

EXPERIMENTAL

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

Other: WavelengthOther: Intensity

Interventions

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

intensitywavelength

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

intensitywavelength

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Lilach Kemer, Dr

    Assuta Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 7, 2016

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share