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| Name | Class |
|---|---|
| Biological Illumination, LLC | INDUSTRY |
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The timing and quality of sleep is governed by environmental and physiologic factors. Environmental factors, especially ambient lighting can impact the circadian system and alter the timing and structure of sleep. Light exposure can also acutely alter neural activation state and impair sleep. These effects all demonstrate marked sensitivity to short-wavelength blue light with maximal sensitivity in the 460-480 nm range. The alerting effects of blue light in the evening persist for at least 3-4 hours after the lights are turned off, and can disturb subsequent sleep. Avoiding these deleterious effects of light exposure prior to sleep on subsequent sleep would be beneficial to sleep quality and potentially health.
The investigators will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light. The investigators 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). In a within-subject design, the investigators will test the hypotheses that exposure to a blue-depleted LED as compared to a CFL exposure at (1) 90 lux or (2) 50 lux will cause significantly:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compact Fluorescent Light 90 lux | Active Comparator | 90 lux exposure of a commercially available Compact Fluorescent Light (CFL). |
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| Blue-depleted LED light 90 lux | Experimental | 90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). |
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| Compact Fluorescent Light 50 lux | Active Comparator | 50 lux exposure of a commercially available Compact Fluorescent Light (CFL). |
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| Blue-depleted LED light 50 lux | Experimental | 50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visible light | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Melatonin Suppression | 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. | 6-h constant posture interval of the light exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Structure | 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. | 8-h time in bed immediately following CFL/LED light exposure. |
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Inclusion Criteria:
(i) Aged between 18-30 years to reduce the confounding effects of lens aging on the transmission of light to the retina;
(ii) Non-smoking for at least 6 months;
(iii) Healthy (no medical, psychiatric or sleep disorders);
(iv) No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, urine chemistry and ECG;
(v) Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative urine pregnancy test;
(vi) Body mass index of > 18 or < 30 kg/m2;
(vii) No drugs or medication likely to affect sleep or alertness, as determined by the investigators;
(viii) Habitual caffeine consumption < 300mg per day on average;
(ix) Habitual alcohol consumption < 10 alcoholic units per week on average.
Exclusion Criteria:
(i) History of alcohol or substance abuse;
(ii) Positive result on drugs of abuse screening;
(iii) Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
(iv) Psychiatric disorder;
(v) Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
(vi) Visual disorder, including but not limited to color blindness, or family history of glaucoma;
(vii) History of intolerance or hypersensitivity to melatonin or melatonin agonists;
(viii) Pregnancy or lactation;
(ix) Shift work;
(x) Transmeridian travel (2 or more time zones) in past 2 months;
(xi) Any other reason as determined by the Principal Investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Steven W Lockley, Ph.D. | Brigham and Women's Hospital; Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Melatonin Suppression | 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. | Posted | Mean | Standard Error | Percentage suppression | 6-h constant posture interval of the light exposure |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious adverse event | Gastrointestinal disorders | Systematic Assessment | gastroenteritis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven W. Lockley | Brigham and Women's Hospital | 617-732-4977 | slockley@hms.harvard.edu |
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Stratified randomized crossover trial. Participants randomized between CFL and LED conditions stratified by light intensity (50 lux and 90 lux).
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| Sleep Quality | Self-reported sleep quality was assessed using a post sleep questionnaire. Score on subjective scale range 1-7, higher scores indicate higher sleep quality. | First morning after 8-h time in bed immediately following CFL/LED light exposure. |
| Subjective Alerting Response | 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. | 6-h constant posture interval of the light exposure. |
| Objective Alerting Response | 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. | 6-h constant posture interval of the light exposure |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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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| Secondary | Sleep Structure | 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. | 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. | Posted | Mean | Standard Error | % total sleep time of total time in bed | 8-h time in bed immediately following CFL/LED light exposure. |
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| Secondary | Sleep Quality | Self-reported sleep quality was assessed using a post sleep questionnaire. Score on subjective scale range 1-7, higher scores indicate higher sleep quality. | 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. | Posted | Mean | Standard Error | Arbitrary units - scale score | First morning after 8-h time in bed immediately following CFL/LED light exposure. |
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| Secondary | Subjective Alerting Response | 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. | Posted | Mean | Standard Error | Score on a scale | 6-h constant posture interval of the light exposure. |
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| Secondary | Objective Alerting Response | 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. | Posted | Mean | Standard Error | Millisecond | 6-h constant posture interval of the light exposure |
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| 0 |
| 8 |
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| 8 |
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| 8 |
| EG001 | 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). | 0 | 9 | 0 | 9 | 1 | 9 |
| EG002 | 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). | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | 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). | 0 | 8 | 0 | 8 | 0 | 8 |
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| Dehydration | Gastrointestinal disorders | Systematic Assessment | Dehydration |
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| 1.0 |
| Superiority |