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Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment, Alzheimer Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lighting Intervention Blue light

Lighting Intervention Green light

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Light and Health Research Center at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Lighting Intervention Blue

Lighting Intervention Green

Arm Description

Blue light (λmax = 451 nm) on and off axis

Green light (λmax = 522 nm) on and off axis

Outcomes

Primary Outcome Measures

Change in melatonin levels

Saliva samples will be collected for melatonin analysis

Secondary Outcome Measures

Full Information

NCT ID

NCT05411822

First Posted

June 2, 2022

Last Updated

May 24, 2023

Sponsor

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT05411822

Brief Title

Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 28, 2021 (Actual)

Primary Completion Date

May 31, 2024 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lighting Intervention Blue

Arm Type

Experimental

Arm Description

Blue light (λmax = 451 nm) on and off axis

Arm Title

Lighting Intervention Green

Arm Type

Experimental

Arm Description

Green light (λmax = 522 nm) on and off axis

Intervention Type

Device

Intervention Name(s)

Lighting Intervention Blue light

Intervention Description

Custom made lighting fixture that will deliver the blue lighting intervention

Intervention Type

Device

Intervention Name(s)

Lighting Intervention Green light

Intervention Description

Custom made lighting fixture that will deliver the green lighting intervention

Primary Outcome Measure Information:

Title

Change in melatonin levels

Description

Saliva samples will be collected for melatonin analysis

Time Frame

one sample will be collected every 30 minutes during each 90 minute study session up to 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Barbara Plitnick, BSN

Phone

518 366-9306

barbara.plitnick@mountsinai.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mariana Figueiro, PhD

Organizational Affiliation

Icahn School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Light and Health Research Center at Mount Sinai

City

Menands

State/Province

New York

ZIP/Postal Code

12204

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Barbara Plitnick, BSN

Phone

518-366-9306

barbara.plitnick@mountsinai.org

First Name & Middle Initial & Last Name & Degree

Mariana Figueiro, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

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