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

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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

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 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.

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)

FacilityCityStateZIPSite coordinators
Light and Health Research Center at Mount SinaiMenandsNew York12204-

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