Investigating the Impact of Duration and Amount of Light on the Circadian System Response - Aim 3

February 12, 2026 updated by: Mariana Figueiro, Icahn School of Medicine at Mount Sinai

Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 3

Investigate the long-term impact of amount and duration of Tailored Lighting Intervention (TLI) obtained from Aims 1 and 2 on sleep, cognition, circadian marker, mood, and behavior in AD/ADRD patients. For this single-arm, randomized, placebo-controlled study, the researchers plan to recruit 100 participants who will experience either the active TLI or the placebo for 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

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
      • Menands, 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

  • Adult
  • 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Lighting Intervention
Combining spectrum and light level, the active TLI will allow the researchers to use a light source that will stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.
Device: Active Lighting Intervention
The TLI will allow researchers to use a light source that will control how the circadian system is stimulated and provide the participants with options as to how the light treatment will be delivered.
Other Names:
  • TLI
Placebo Comparator: Control Lighting Intervention
The control TLI will allow the researchers to use a light source that will not stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.
Device: Control Lighting Intervention
The TLI will allow researchers to use a light source that will not stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.
Other Names:
  • TLI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Disturbance using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Up to Week 36
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 full scale range of 0 to 21. A higher score indicates higher sleep disturbance.
Up to Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep efficiency using actigraphy
Time Frame: Up to Week 36
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 36
Depression using the Cornell Scale for Depression in Dementia (CSDD)
Time Frame: Up to Week 36
The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. Full Scale ranges from 0 to 38 with a higher score indicating greater depression.
Up to Week 36
Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame: Up to Week 36
The CMAI assesses the frequency of manifestations of agitated behaviors in elderly persons. The CMAI is a caregivers' rating questionnaire consisting of 29 agitated behaviors, each rated on a 7-point scale of frequency. Score ranges from 30 to 210 with a higher score indicating higher agitated behavior.
Up to Week 36
Light measurements using the Daysimeter
Time Frame: Up to Week 36
Circadian light measurements will be collected during waking hours for 7 days each assessment week using the daysimeter. The light measurement is reported as Lux levels.
Up to Week 36
Cognitive status Using the Montreal Cognitive Assessment (MOCA)
Time Frame: Up to Week 36
The MoCA is a 1-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. Total score range from 0 to 30. Lower score indicates lower cognitive status.
Up to Week 36

Collaborators and Investigators

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

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute on Aging (NIA)

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)

December 3, 2024

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-20-01736 Aim 3
  • 5R01AG034157-13 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Overall results will be shared not individual

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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