Skip to main content
OpenTrials
Completed

NCT Number: NCT05411822

Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Light and Health Research Center at Mount Sinai

Menands, New York, 12204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mild cognitive impairment
  • age matched healthy control
  • macular pigment density either < 0.3 or > 0.5

Exclusion criteria

  • extensive brain vascular disease
  • Parkinson's disease
  • bipolar disorder
  • seasonal depression
  • diabetes
  • high blood pressure
  • obstructing cataracts
  • macular degeneration
  • diabetic retinopathy
  • use of melatonin supplements
  • use of beta blockers
  • use of sleep medications
  • use of antidepressant medication

Treatment and study plan

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

Primary outcomes

  1. Melatonin Levels

    Time frame: post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks)

    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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment and Alzheimer's Disease

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2022
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.