SleepNCT02839395
The Effects of Acute vs. Chronic of Screen Illumination on: Sleep Efficacy and Architecture, Physiology, Emotion and Behavior: Possible Effect on Human Health
A study testing Acute and Chronic in people with Sleep and Emotion, run by Assuta Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Acute and Chronic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 20-45,
- healthy
- No history of visual disturbances
- No history of sleep disorders
Who cannot join
- 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
About this study
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.
Read the detailed description
The investigators will examine whether there is a difference between one-time and multiple exposures to computer screen lighting (350 lux). The investigators hypothesize that multiple and continuous exposure will have a more significant detrimental effect on the quality of sleep and consequently on performance, emotional, and physiological indicators, than one-time exposure to screen light.
Procedure:
On the base-line, first and fifth night of the study, at the end of two hours of exposure to screen light, the subject will be connected to the sleep test system by a skilled technician. On all other nights (nights 2-4), exposure to computer light only, will be conducted and at the end of the exposure the subject will be asked to go to sleep. During the entire experimental period the subject will wear an Actigraph watch to ensure regular sleeping hours. In addition, subjects will be asked not to expose themselves to a computer/tablet/smartphone screen from 20:00 h to wake up.
An Actigraph will monitor their sleep during the week of the experiment. The subject will be invited to attend the Sleep Institute at 21:00 h. The subject will be asked to enter the test room, which will be dark, and sit in front of a computer screen for two hours at a distance of about 60 cm from the screen and perform the on-screen tasks between the hours of 21:00 and 23:00 h. The tasks will include: reading and writing Microsoft Word documents, , and answering questions dealing with a document read and, solving verbal and arithmetic problems, while attempting to accomplish the task correctly and in the quickest time possible. The subject will be told that the purpose of the study is to examine the effect of the content of the tasks on the quality of sleep. During exposure, the subject will be allowed to eat and drink, but do not go to the bathroom. At the end of two hours of exposure to screen light, the subject will be connected to the sleep test system by a skilled technician. Body temperature and 6-hydroxymelatonin sulfate(6-SMT) in the urine will be measured using the on-set and off-set methods three times, at 21:00, 23:00 h, and close to the falling asleep time. Three measurements will be taken after awakening. After the sleep test system is installed, the subject will be asked to go to sleep and in the morning will be woken at his/her average waking time. After the examinee has been woken and has provided a urine sample and body temperature measurement, the sleep test system will be removed and the examinees will be given 30 minutes to organize him/herself, before performing the following tasks to assess his/her degree of fatigue and sleepiness: Continous Performance Test (CPT-III), the Brief Symptoms Inevntory (BSI) emotional questionnaire, and the Epworth Sleepiness Scale (ESS) and Karolinska Sleepiness Scale (KSS) questionnaire.
- Being tested
- No intervention- base line, Acute, Chronic
- Keywords
- screen illumination, melatonin, body temperature, cognitive functioning, light pollution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention- base lineOther
the subject will sited in a dim light room. No screen light illumination.
AcuteOther
The subject will be sited in front of computer screen light illumination for 2 hours.
ChronicOther
The subject will be sited in front of computer screen light illumination for 2 hours for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| base line | Active comparator | First night is the base line- no exposure to computer screen illumination. Receives: Other: No intervention- base line |
| Acute | Experimental | Second night is the acute exposure to computer screen illumination. Receives: Other: Acute |
| Chronic | Experimental | Chronic is the effect after five nights of exposure to computer screen light illumination. Receives: Other: Chronic |
What is being measured
The primary outcome is the main question the study is designed to answer.
body temperature
body temperature in celsius degree.physiological marker
Measured: 12 hours
Melatonin secretion
Melatonin -Sulfate Urine ELISA 6-SMT ng/ml. physiological marker
Measured: 12 hours
sleepiness
ESS questionnaire score- number
Measured: 1 day
BSI Questionnaire
assess the subject's emotional state- number
Measured: 1 day
Subjective sleepiness
KSS questionnaire-number
Measured: 1 day
attention
a neuropsychological computerized attention and concentration test, designed to test attentional functions. number
Measured: 1 hour
total Sleep time
total sleep time in minutes. physiological marker
Measured: 1 night
Sleep efficiency
percentage of sleep efficiency- physiological marker
Measured: 1 night
sleep latency to sleep stage1
time in minute to sleep stage 1. physiological marker
Measured: 1 night
sleep latency to sleep stage2
time in minute to sleep stage 2. physiological marker
Measured: 1 night
wake %TIB
percentage of wake from Time in bed. physiological marker
Measured: 1 night
REM %TIB
percentage of REM from Time in bed. physiological marker
Measured: 1 night
staege1%TIB
percentage of sleep stage1 from Time in bed. physiological marker
Measured: 1 night
stage2%TIB
percentage of sleep stage2 from Time in bed.physiological marker
Measured: 1 night
stage4%TIB
percentage of sleep stage4 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.
- First posted21 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilach Kemer, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839395
- Sponsor's protocol ID
- 0005-16-ASMC
- Status last verified
- Jan 2018
- First submitted
- 7 Jul 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute vs. Chronic of Screen Illumination on: Sleep Efficacy and Architecture, Physiology, Emotion and Behavior: Possible Effect on Human Health
- ClinicalTrials.gov ID
- NCT02839395
- Acronym / sponsor ID
- 0005-16-ASMC
- Keywords
- screen illumination, melatonin, body temperature, cognitive functioning, light pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will examine whether there is a difference between one-time and multiple exposures to computer screen lighting (350 lux). The investigators hypothesize that multiple and continuous exposure will have a more significant detrimental effect on the quality of sleep and consequently on performance, emotional, and physiological indicators, than one-time exposure to screen light.
Procedure:
On the base-line, first and fifth night of the study, at the end of two hours of exposure to screen light, the subject will be connected to the sleep test system by a skilled technician. On all other nights (nights 2-4), exposure to computer light only, will be conducted and at the end of the exposure the subject will be asked to go to sleep. During the entire experimental period the subject will wear an Actigraph watch to ensure regular sleeping hours. In addition, subjects will be asked not to expose themselves to a computer/tablet/smartphone screen from 20:00 h to wake up.
An Actigraph will monitor their sleep during the week of the experiment. The subject will be invited to attend the Sleep Institute at 21:00 h. The subject will be asked to enter the test room, which will be dark, and sit in front of a computer screen for two hours at a distance of about 60 cm from the screen and perform the on-screen tasks between the hours of 21:00 and 23:00 h. The tasks will include: reading and writing Microsoft Word documents, , and answering questions dealing with a document read and, solving verbal and arithmetic problems, while attempting to accomplish the task correctly and in the quickest time possible. The subject will be told that the purpose of the study is to examine the effect of the content of the tasks on the quality of sleep. During exposure, the subject will be allowed to eat and drink, but do not go to the bathroom. At the end of two hours of exposure to screen light, the subject will be connected to the sleep test system by a skilled technician. Body temperature and 6-hydroxymelatonin sulfate(6-SMT) in the urine will be measured using the on-set and off-set methods three times, at 21:00, 23:00 h, and close to the falling asleep time. Three measurements will be taken after awakening. After the sleep test system is installed, the subject will be asked to go to sleep and in the morning will be woken at his/her average waking time. After the examinee has been woken and has provided a urine sample and body temperature measurement, the sleep test system will be removed and the examinees will be given 30 minutes to organize him/herself, before performing the following tasks to assess his/her degree of fatigue and sleepiness: Continous Performance Test (CPT-III), the Brief Symptoms Inevntory (BSI) emotional questionnaire, and the Epworth Sleepiness Scale (ESS) and Karolinska Sleepiness Scale (KSS) questionnaire.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| base line | Active comparator | Other: No intervention- base lineFirst night is the base line- no exposure to computer screen illumination. |
| Acute | Experimental | Other: AcuteSecond night is the acute exposure to computer screen illumination. |
| Chronic | Experimental | Other: ChronicChronic is the effect after five nights of exposure to computer screen light illumination. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 20-45,
- healthy
- No history of visual disturbances
- No history of sleep disorders
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention- base linethe subject will sited in a dim light room. No screen light illumination. | Other | base line |
| AcuteThe subject will be sited in front of computer screen light illumination for 2 hours. | Other | Acute |
| ChronicThe subject will be sited in front of computer screen light illumination for 2 hours for 5 consecutive days. | Other | Chronic |
Primary outcome
body temperature
Time frame: 12 hours
body temperature in celsius degree.physiological marker
Melatonin secretion
Time frame: 12 hours
Melatonin -Sulfate Urine ELISA 6-SMT ng/ml. physiological marker
sleepiness
Time frame: 1 day
ESS questionnaire score- number
BSI Questionnaire
Time frame: 1 day
assess the subject's emotional state- number
Subjective sleepiness
Time frame: 1 day
KSS questionnaire-number
attention
Time frame: 1 hour
a neuropsychological computerized attention and concentration test, designed to test attentional functions. number
total Sleep time
Time frame: 1 night
total sleep time in minutes. physiological marker
Sleep efficiency
Time frame: 1 night
percentage of sleep efficiency- physiological marker
sleep latency to sleep stage1
Time frame: 1 night
time in minute to sleep stage 1. physiological marker
sleep latency to sleep stage2
Time frame: 1 night
time in minute to sleep stage 2. physiological marker
wake %TIB
Time frame: 1 night
percentage of wake from Time in bed. physiological marker
REM %TIB
Time frame: 1 night
percentage of REM from Time in bed. physiological marker
staege1%TIB
Time frame: 1 night
percentage of sleep stage1 from Time in bed. physiological marker
stage2%TIB
Time frame: 1 night
percentage of sleep stage2 from Time in bed.physiological marker
stage4%TIB
Time frame: 1 night
percentage of sleep stage4 from Time in bed.physiological marker
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acute and Chronic in people with Sleep and Emotion, 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 4 inclusion and 5 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 9 Jan 2018. 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 15 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 9 Jan 2018.