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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

6-h constant posture interval of the light exposure

Results posted on

2021-09-14

Participant Flow

Participant milestones

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).
Overall Study
STARTED
8
9
8
8
Overall Study
COMPLETED
8
8
8
8
Overall Study
NOT COMPLETED
0
1
0
0

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

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
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 exposure

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.

Outcome measures

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).
Melatonin Suppression
71.4 Percentage suppression
Standard Error 5.7
70.1 Percentage suppression
Standard Error 7.2
54.3 Percentage suppression
Standard Error 5.9
32.5 Percentage suppression
Standard Error 7.6

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

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).
Sleep Structure
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

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

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).
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

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 exposure

Mean 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Blue-depleted LED Light 90 Lux

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Compact Fluorescent Light 50 Lux

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Blue-depleted LED Light 50 Lux

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Dr. Steven W. Lockley

Brigham and Women's Hospital

Phone: 617-732-4977

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place