Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment
Part of paid clinical trials in Menands, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT05411822
- Status
- Completed
Conditions
- Alzheimer Disease
- Mild Cognitive Impairment
Eligibility Criteria
- Sex
- ALL
- Age
- 55 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Lighting Intervention Blue light — DEVICECustom made lighting fixture that will deliver the blue lighting intervention. Blue light (λmax = 451 nm) on axis and off axis.
- Lighting Intervention Green light — DEVICECustom 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
Study Details
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.
Key Dates
- Start date
- Jun 14, 2021
- Status verified
- Jun 2025
- Primary completion
- May 31, 2024
- Completion
- May 31, 2024
Study Design
- Enrollment
- 36 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Participants with Mild Cognitive ImpairmentEvery 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.
Primary Outcome Measure
Melatonin Levels [ Time Frame: post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Light and Health Research Center at Mount Sinai | Menands | New York | 12204 | - |
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