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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG070713 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this research study is to investigate the relationship between light, the thickness of the pigment at the back of your eye, melatonin levels, and memory. The study will investigate whether changing light distribution pattern from "on-axis"' (i.e., directed along the eye's visual axis to the fovea) to "off-axis" (i.e., directed on the periphery of the eye's visual axis) impact melatonin suppression in 24 mild cognitive impairment participants and 24 healthy, age-matched controls.
Eligible enrolled subjects will be exposed to 4 different lighting conditions in addition to one dark control condition. There will be 5 study session and each one will last for 90 minutes and will be separated by one week. Subjects will collect 3 saliva samples, each one 30 minutes apart for melatonin levels during each study session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Mild Cognitive Impairment | Experimental | Every participant experienced all 5 conditions: Blue light (λmax = 451 nm) on axis and off axis. Green light (λmax = 522 nm) on and off axis Dim-light control condition (< 5 lux at the eye) for 30 min each narrowband source will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lighting Intervention Blue light | Device | Custom made lighting fixture that will deliver the blue lighting intervention. Blue light (λmax = 451 nm) on axis and off axis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Melatonin Levels | Saliva samples collected for melatonin levels for the different conditions. Blue light (λmax = 451 nm) on axis and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Green light (λmax = 522 nm) on and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Dim-light control condition: (< 5 lux at the eye) for 30 min | post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariana Figueiro, PhD | Icahn School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Light and Health Research Center at Mount Sinai | Menands | New York | 12204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Mild Cognitive Impairment | Every participant experienced all 5 conditions: Blue light (λmax = 451 nm) on axis and off axis. Green light (λmax = 522 nm) on and off axis Dim-light control condition (< 5 lux at the eye) for 30 min each narrowband source will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. |
| FG001 | Matched Control | Healthy Age-Matched Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Mild Cognitive Impairment | Every participant experienced all 5 conditions: Blue light (λmax = 451 nm) on axis and off axis. Green light (λmax = 522 nm) on and off axis Dim-light control condition (< 5 lux at the eye) for 30 min each narrowband source will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Levels | Saliva samples collected for melatonin levels for the different conditions. Blue light (λmax = 451 nm) on axis and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Green light (λmax = 522 nm) on and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Dim-light control condition: (< 5 lux at the eye) for 30 min | Posted | Mean | Standard Deviation | pg/mL | post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks) |
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60 minutes of intervention over 1 day per week for 5 weeks.
Adverse events reporting by comparing conditions. All participants received all conditions.
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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 | Mild Cognitive Impairment - Lighting Intervention Blue - On Axis | Blue light (λmax = 451 nm) on axis for each narrowband source, designated on-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mariana Figueiro, PhD | Icahn School of Medicine at Mount Sinai | (518) 366-9306 | Mariana.Figueiro@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2021 | Apr 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| Lighting Intervention Green light | Device | Custom made lighting fixture that will deliver the green lighting intervention. Green light (λmax = 522 nm) on and off axis |
|
| Dim-light control condition | Other | (< 5 lux at the eye) for 30 min |
|
| BG001 | Healthy Age-Matched Control | Healthy Age-Matched Control |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| OG001 | Healthy Control | Participants who are healthy. |
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|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Mild Cognitive Impairment - Blue - Off Axis | Blue light (λmax = 451 nm) for each narrowband source, designated off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Mild Cognitive Impairment - Lighting Intervention Green - On Axis | Green light (λmax = 522 nm) on and off axis for each narrowband source, designated on-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | Mild Cognitive Impairment - Green - Off Axis | Green light (λmax = 522 nm) for each narrowband source, designated off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG004 | Mild Cognitive Impairment - Dim Light | Dim-light control condition (< 5 lux at the eye) for 30 min | 0 | 13 | 0 | 13 | 0 | 13 |
| EG005 | Healthy Control - Lighting Intervention Blue - On Axis | Blue light (λmax = 451 nm) on axis for each narrowband source, designated on-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG006 | Healthy Control - Blue - Off Axis | Blue light (λmax = 451 nm) for each narrowband source, designated off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG007 | Health Control - Lighting Intervention Green - On Axis | Green light (λmax = 522 nm) on and off axis for each narrowband source, designated on-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG008 | Healthy Control - Green - Off Axis | Green light (λmax = 522 nm) for each narrowband source, designated off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG009 | Health Control Dim Light | Dim-light control condition (< 5 lux at the eye) for 30 min | 0 | 15 | 0 | 15 | 0 | 15 |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |