Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Interventions: Device: Lighting Intervention Green light; Device: Lighting Intervention Blue light

• Registration Number: NCT05411822
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-06-14
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lighting Intervention Green	Lighting Intervention Green light	Green light (λmax = 522 nm) on and off axis
Lighting Intervention Blue	Lighting Intervention Blue light	Blue light (λmax = 451 nm) on and off axis

Primary Outcome Measures

Name	Time	Method
Change in melatonin levels	one sample will be collected every 30 minutes during each 90 minute study session up to 5 weeks	Saliva samples will be collected for melatonin analysis

Trial Locations

Locations (1)

Light and Health Research Center at Mount Sinai; 🇺🇸 Menands, New York, United States