Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

May 28, 2026 updated by: Mariana Figueiro, Icahn School of Medicine at Mount Sinai
Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12204
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score <25
  • Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5

Exclusion Criteria:

  • Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease
  • Obstructing cataracts
  • Severe macular degeneration
  • Use of sleep medication
  • Use of oral melatonin
  • untreated moderate to severe sleep apnea
  • Severe restless leg syndrome
  • Blindness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Lighting Intervention
Lighting intervention designed to effect the circadian system then will receive the control lighting intervention.
Device: Active Lighting Intervention
Lighting intervention using high light levels designed to effect the circadian system
Device: Control Lighting Intervention
Lighting intervention using low light levels designed to not effect the circadian system
Placebo Comparator: Control Lighting Intervention
Lighting intervention using low light levels designed to not effect the circadian system
Device: Control Lighting Intervention
Lighting intervention using low light levels designed to not effect the circadian system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Disturbance using the Pittsburgh Sleep Quality Index
Time Frame: up to week 14
The PSQI is used to measure sleep quality and is composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each subscale is scored 0 to 3. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A higher score indicates higher sleep disturbance
up to week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep efficiency using actigraphy
Time Frame: up to week 14
Actigraphs will be worn continuously for 7 days during each assessment week. Changes in sleep efficiency will be measured using the actigraphy software. Sleep efficiency is a calculated as a ratio of the time spent in bed and the time spent sleeping.
up to week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Mariana Figueiro, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-20-01736 Aim 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Overall results will be shared, not individual data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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