Trial Outcomes & Findings for Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep (NCT NCT01586039)
NCT ID: NCT01586039
Last Updated: 2021-09-14
Results Overview
Melatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. AUC was calculated during the 6 h of light exposure and the corresponding 6-h interval 24 hours earlier. Higher values indicate more light-induced melatonin suppression.
COMPLETED
NA
33 participants
6-h constant posture interval of the light exposure
2021-09-14
Participant Flow
Participant milestones
| Measure |
Compact Fluorescent Light 90 Lux
90 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 90 Lux
90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Compact Fluorescent Light 50 Lux
50 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 50 Lux
50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
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|---|---|---|---|---|
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Overall Study
STARTED
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8
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9
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8
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8
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|
Overall Study
COMPLETED
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8
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8
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8
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8
|
|
Overall Study
NOT COMPLETED
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0
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1
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep
Baseline characteristics by cohort
| Measure |
Compact Fluorescent Light 90 Lux
n=8 Participants
90 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 90 Lux
n=8 Participants
90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Compact Fluorescent Light 50 Lux
n=8 Participants
50 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 50 Lux
n=8 Participants
50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Total
n=32 Participants
Total of all reporting groups
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|---|---|---|---|---|---|
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Age, Continuous
|
25.0 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
23.6 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
24.8 years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
24.4 years
STANDARD_DEVIATION 2.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6-h constant posture interval of the light exposureMelatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. AUC was calculated during the 6 h of light exposure and the corresponding 6-h interval 24 hours earlier. Higher values indicate more light-induced melatonin suppression.
Outcome measures
| Measure |
Compact Fluorescent Light 90 Lux
n=8 Participants
90 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 90 Lux
n=8 Participants
90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Compact Fluorescent Light 50 Lux
n=8 Participants
50 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 50 Lux
n=8 Participants
50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
|---|---|---|---|---|
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Melatonin Suppression
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71.4 Percentage suppression
Standard Error 5.7
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70.1 Percentage suppression
Standard Error 7.2
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54.3 Percentage suppression
Standard Error 5.9
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32.5 Percentage suppression
Standard Error 7.6
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SECONDARY outcome
Timeframe: 8-h time in bed immediately following CFL/LED light exposure.Population: Due to limited financial resources and based on the results of the primary outcome of melatonin suppression in the 90-lux condition, we did not score the PSG data for sleep stage in the 90-lux condition and therefore could not perform an analysis of sleep efficiency. PSG data in one 50-lux condition participant was not collected due to equipment malfunction.
Sleep efficiency assessed by polysomnography. Sleep efficiency refers to the percentage of time a person sleeps, in relation to the amount of time a person spends in bed trying to sleep. The percentage is calculated by dividing the Total Sleep Time by the Total Time in Bed.
Outcome measures
| Measure |
Compact Fluorescent Light 90 Lux
90 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 90 Lux
90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Compact Fluorescent Light 50 Lux
n=8 Participants
50 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 50 Lux
n=7 Participants
50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
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|---|---|---|---|---|
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Sleep Structure
|
—
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—
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91.5 % total sleep time of total time in bed
Standard Error 1.0
|
92.4 % total sleep time of total time in bed
Standard Error 1.1
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SECONDARY outcome
Timeframe: First morning after 8-h time in bed immediately following CFL/LED light exposure.Population: Post-sleep questionnaires from two participants (each completing once in the "Compact Fluorescent Light 90 lux" condition and once in the "Blue-depleted LED light 90 lux" condition) were not collected due to technical error. As a result n=6 were available for data analysis.
Self-reported sleep quality was assessed using a post sleep questionnaire. Score on subjective scale range 1-7, higher scores indicate higher sleep quality.
Outcome measures
| Measure |
Compact Fluorescent Light 90 Lux
n=6 Participants
90 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 90 Lux
n=6 Participants
90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Compact Fluorescent Light 50 Lux
n=8 Participants
50 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 50 Lux
n=8 Participants
50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
|---|---|---|---|---|
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Sleep Quality
|
4.5 Arbitrary units - scale score
Standard Error 0.2
|
4.6 Arbitrary units - scale score
Standard Error 0.2
|
4.8 Arbitrary units - scale score
Standard Error 0.3
|
4.8 Arbitrary units - scale score
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 6-h constant posture interval of the light exposure.Self-reported sleepiness measured during the light exposure using the Karolinska Sleepiness Scale (KSS). Range of scores 1-9, higher score indicate higher subjective sleepiness. Measures were taken hourly throughout the 6-hour constant posture interval of the light exposure and then averaged to calculate a single value per participant.
Outcome measures
| Measure |
Compact Fluorescent Light 90 Lux
n=8 Participants
90 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 90 Lux
n=8 Participants
90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Compact Fluorescent Light 50 Lux
n=8 Participants
50 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 50 Lux
n=8 Participants
50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
|---|---|---|---|---|
|
Subjective Alerting Response
|
4.1 Score on a scale
Standard Error 0.2
|
4.3 Score on a scale
Standard Error 0.3
|
4.3 Score on a scale
Standard Error 0.3
|
4.3 Score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 6-h constant posture interval of the light exposureMean reaction time assessed using the 10-minute psychomotor vigilance test. Higher numbers indicate slower reaction times indicating less alertness. Measures were taken hourly throughout the 6-hour constant posture interval of the light exposure and then averaged to calculate a single value per participant.
Outcome measures
| Measure |
Compact Fluorescent Light 90 Lux
n=8 Participants
90 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 90 Lux
n=8 Participants
90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Compact Fluorescent Light 50 Lux
n=8 Participants
50 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 50 Lux
n=8 Participants
50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
|---|---|---|---|---|
|
Objective Alerting Response
|
247.7 Millisecond
Standard Error 7.2
|
249.7 Millisecond
Standard Error 7.3
|
229.3 Millisecond
Standard Error 4.6
|
238.2 Millisecond
Standard Error 6.7
|
Adverse Events
Compact Fluorescent Light 90 Lux
Blue-depleted LED Light 90 Lux
Compact Fluorescent Light 50 Lux
Blue-depleted LED Light 50 Lux
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Compact Fluorescent Light 90 Lux
n=8 participants at risk
90 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 90 Lux
n=9 participants at risk
90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Compact Fluorescent Light 50 Lux
n=8 participants at risk
50 lux exposure of a commercially available Compact Fluorescent Light (CFL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
Blue-depleted LED Light 50 Lux
n=8 participants at risk
50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Visible light: We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Non-serious adverse event
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place