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Sleep DisorderNCT02957383

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

A study testing Wavelength and Intensity in people with Sleep Disorder, run by Assuta Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Disorder
What is being tested?
Wavelength and Intensity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
No sites listed yet
Study dates
Jul 2015to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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.

Read the detailed description

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).

Melatonin: Urine samples were collected for analyzing melatonin levels by measuring 6-sulfahydroxymelatonin (6-SMT) concentration, the major metabolite of the hormone in urine (de Almeida et al., 2011). The quantitative determination of 6-SMT in urine was completed by a solid phase enzyme-linked immunosorbent assay (ELISA # RE54031; IBL, Hamburg; Germany) as described previously (Zubidat \& Haim, 2007). 6-SMT concentrations (ng/mL) were spectrophotometrically determined by ELISA microplate reader at 450 nm with reference wavelength 650 nm (PowerWave HT, Biotek, Winooski; USA) and analyzed by Gen5TM Data Analysis Software (Version 2, Biotek, Winooski; USA).

Urine samples were collected on all four days of the experiment at three time points: 21:00, 23:00 and at wake time. All urine samples were frozen (-20OC) immediately after collection. Melatonin was then analyses and secretion parameters were estimated. As the first morning sample concentration of 6-SMT has been extensively used as an estimate of overnight melatonin secretion (McMullan et al., 2013), we used this sample to represent the maximum (100%) MLT secretion per participant. The night samples (at 21:00 and 23:00) were transformed using the formula value at 21:00 or 23:00 /value in wake time *100 to reflect the percentage change in MLT secretion per participant.

Temperature: Oral temperature was measured using an electronic oral thermometer (Domotherem, UEBE Medical GMBH, Germany).

Procedure:

Recruitment ads were placed in social network websites stating basic inclusion criteria and study details. Interested persons were initially interviewed via phone to rule out major exclusion criteria (e.g. age, general health, and sleep patterns). Persons who were eligible and interested in participating were invited to the sleep laboratory at Assuta Medical Center (Tel Aviva, Israel) for in-lab screening. At the screening visit, all participants signed informed of consent and filled out intake questionnaires, including demographic and health questionnaires, PSQI, and the Horne-Ostberg questionnaire). Participants then received an actigraph for one week to assess the quality and quantity of their sleep and sleep wake patterns and schedules.

Following the home screening, participants were scheduled for four in-lab testing nights across two consecutive weeks. Participants were always scheduled on Sunday and Wednesday nights for each week. For the duration of the 2-week experimental period, all participants were requested to sleep in accordance with their normal sleep schedule, both at home and at the laboratory.

A repeated measures design was used, with two independent variables: screen luminance (or light intensity emitted from the screen) and light wavelength. The first, luminance at two levels: low - 80 lux (35mw/cm2) and high - 350 lux (160mw/cm2). The second, wavelength at two levels: short (SWL)-485 nm (13500k) and long (LWL)-620 nm (4250k). Luminance and wavelength levels were measured and adjusted using a light metering device (AvaSpec-2048-FT-SDU; Avantes, Inc., Eerbeek, Netherlands). There were three dependent measures that were analyzed separately, sleep, melatonin secretion, and oral temperature. Each participant underwent all four experimental conditions in counterbalanced order.

Participants arrived at sleep laboratory at 21:00h on all experimental nights. The experiment room was about 12 m2 in size and included a desk with a 22-inch computer LED (Light Emitting Diode) screen (Model 226V4L, Philips, USA) and a bed. The screen was placed at a distance of about 60 cm from the participant and at eye level.

The room was dark and the room temperature was set to 22OC. Participants sat in front of the computer screen for two hours and performed onscreen tasks between 21:00h and 23:00h. Tasks were reading texts and answering related questions, writing exercises and solving verbal and arithmetic problems. Participants were not informed of the differing light conditions and were told that the purpose of the study is to examine the effect of the content of the tasks on sleep.

During exposure, the subjects were allowed to eat light food and drink (non-caffeinated beverages only). Participants were requested to go to the bathroom before testing and were not allowed leave the room for the duration of the testing. Following the light exposure, participants were connected to the sleep testing system by a skilled technician and requested to go to sleep. Bedtimes and wake times were based on the average sleep/wake time as indicated in the individual actigraphy reports. Oral temperature was taken at six time points, three on the testing night: 21:00h, 23:00h, and immediately prior to bedtime and at three the following morning, at 0, 60, and 120 minutes after awakening. Urine samples were collected at three time points: 21:00h, 23:00h, and immediately following morning awakening. This protocol was repeated for each of the four testing nights. Upon completion of the study protocol participants were given monetary compensation for their participation in the study.

Statistical analysis:

Two-way (wavelength X intensity) repeated measures (RM) ANOVAs were performed to evaluate mean value differences for all sleep parameters. Three-way (wavelength x intensity X time) RM ANOVAs were performed to evaluate mean value differences in melatonin and temperature indices. Post-hoc Tukey tests were performed for significant ANOVAs. Two-tailed p-values below 0.05 were considered significant. Statistical analyses were preformed using SPSS, version 20 (SPSS Inc., Chicago, IL, USA).

Conditions
Sleep Disorder
Being tested
Wavelength, Intensity
Keywords
Sleep, Melatonin, Circadian Rhythm, Temperature, screen illumination
Medical subject headings
Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WavelengthOther

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

  • IntensityOther

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

Study groups in NCT02957383
Study groupRoleWhat they receive
wavelengthExperimentalWavelength at two levels: short (SWL)-485 nm (13500k) and long (LWL)-620 nm (4250k)
Receives: Other: Wavelength; Other: Intensity
intensityExperimentalLuminance at two levels: low - 80 lux (35mw/cm2) and high - 350 lux (160mw/cm2).
Receives: Other: Wavelength; Other: Intensity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body temperature

    Oral body temperature, physiological marker

    Measured: 12 hours

  2. Melatonin secretion

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

    Measured: 12 hours

  3. Epworth Sleepiness Scale (ESS) questionire- Sleepiness

    Epworth Sleepiness Scale (ESS) questionire score- Number

    Measured: 1 day

  4. Brief Symptom Inventory (BSI)- questionaire

    Assess the subjects emotional state- number

    Measured: 1 day

  5. Karolinska Sleep Questionnaire (KSS)-Subjective sleepiness

    KSS questionaire - number

    Measured: 1 day

  6. Attention

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

    Measured: 1hour

  7. Total Sleep Time

    Total sleep time in minute. physiological marker

    Measured: 1 night

  8. sleep efficiency

    Percentage of sleep efficiency , physiological marker

    Measured: 1 night

  9. Sleep latency to stage 1

    Tine in minute to sleep stage 1, physiological marker

    Measured: 1 night

  10. Sleep latency to stage 2

    Tine in minute to sleep stage 2, physiological marker

    Measured: 1 night

  11. Wake% TIB

    Percentage of wake from time in bed, physiological marker

    Measured: 1 night

  12. Stage 1% TIB

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

    Measured: 1 night

  13. Stage 2% TIB

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

    Measured: 1 night

  14. SWS% TIB

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

    Measured: 1 night

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2016 (estimated)
  2. Study startJul 2015
  3. Primary completionMar 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02957383
Sponsor's protocol ID
2014068
Status last verified
Nov 2016
First submitted
3 Nov 2016
Last updated
8 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Wavelength and Intensity in people with Sleep Disorder, run by Assuta Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body temperature (time frame: 12 hours). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.

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