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.
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 group | Role | What they receive |
|---|---|---|
| wavelength | Experimental | Wavelength at two levels: short (SWL)-485 nm (13500k) and long (LWL)-620 nm (4250k) Receives: Other: Wavelength; Other: Intensity |
| intensity | Experimental | Luminance 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.
Body temperature
Oral body temperature, physiological marker
Measured: 12 hours
Melatonin secretion
Melatonin - Sulfate Urine ELISA 6-SMT ng/ml, physiological marker
Measured: 12 hours
Epworth Sleepiness Scale (ESS) questionire- Sleepiness
Epworth Sleepiness Scale (ESS) questionire score- Number
Measured: 1 day
Brief Symptom Inventory (BSI)- questionaire
Assess the subjects emotional state- number
Measured: 1 day
Karolinska Sleep Questionnaire (KSS)-Subjective sleepiness
KSS questionaire - number
Measured: 1 day
Attention
continuous performance test (CPT-III) a computerized attention and concentration test. number
Measured: 1hour
Total Sleep Time
Total sleep time in minute. physiological marker
Measured: 1 night
sleep efficiency
Percentage of sleep efficiency , physiological marker
Measured: 1 night
Sleep latency to stage 1
Tine in minute to sleep stage 1, physiological marker
Measured: 1 night
Sleep latency to stage 2
Tine 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
Stage 1% TIB
Percentage of sleep stage 1 from time in bed, physiological marker
Measured: 1 night
Stage 2% TIB
Percentage of sleep stage 2 from time in bed, physiological marker
Measured: 1 night
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.
- First posted7 Nov 2016 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Randomised
- Intervention model
- Factorial
- 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
- Investigators
- Lilach Kemer, Dr, Principal investigator, Assuta Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evning Exposure to Computer Screen Disrupts Sleep, Attention and Biological Rhythms
- ClinicalTrials.gov ID
- NCT02957383
- Acronym / sponsor ID
- 2014068
- Conditions
- Sleep Disorder
- Keywords
- Sleep, Melatonin, Circadian Rhythm, Temperature, screen illumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Nov 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.
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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wavelength | Experimental | Other: Wavelength, Other: IntensityWavelength at two levels: short (SWL)-485 nm (13500k) and long (LWL)-620 nm (4250k) |
| intensity | Experimental | Other: Wavelength, Other: IntensityLuminance at two levels: low - 80 lux (35mw/cm2) and high - 350 lux (160mw/cm2). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Wavelengthwavelength at two levels: short (SWL)-485 nm (13500k) and long (LWL)-620 nm (4250k) | Other | intensity, wavelength |
| IntensityLuminance at two levels: low - 80 lux (35mw/cm2) and high - 350 lux (160mw/cm2 | Other | intensity, wavelength |
Primary outcome
Body temperature
Time frame: 12 hours
Oral body temperature, physiological marker
Melatonin secretion
Time frame: 12 hours
Melatonin - Sulfate Urine ELISA 6-SMT ng/ml, physiological marker
Epworth Sleepiness Scale (ESS) questionire- Sleepiness
Time frame: 1 day
Epworth Sleepiness Scale (ESS) questionire score- Number
Brief Symptom Inventory (BSI)- questionaire
Time frame: 1 day
Assess the subjects emotional state- number
Karolinska Sleep Questionnaire (KSS)-Subjective sleepiness
Time frame: 1 day
KSS questionaire - number
Attention
Time frame: 1hour
continuous performance test (CPT-III) a computerized attention and concentration test. number
Total Sleep Time
Time frame: 1 night
Total sleep time in minute. physiological marker
sleep efficiency
Time frame: 1 night
Percentage of sleep efficiency , physiological marker
Sleep latency to stage 1
Time frame: 1 night
Tine in minute to sleep stage 1, physiological marker
Sleep latency to stage 2
Time frame: 1 night
Tine in minute to sleep stage 2, physiological marker
Wake% TIB
Time frame: 1 night
Percentage of wake from time in bed, physiological marker
Stage 1% TIB
Time frame: 1 night
Percentage of sleep stage 1 from time in bed, physiological marker
Stage 2% TIB
Time frame: 1 night
Percentage of sleep stage 2 from time in bed, physiological marker
SWS% TIB
Time frame: 1 night
Percentage of sleep stage SWS 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 8 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Lilach Kemer, Dr principal investigator
Assuta Medical Center
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.