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

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: Recruiting
• Conditions: Sleep Disturbance; Alzheimer's Disease
• Intervention / Treatment: Device: Active Lighting Intervention; Device: Control Lighting Intervention

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara Plitnick; Phone Number: 518-242-4603; Email: barbara.plitnick@mountsinai.org

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12204
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Mariana Figueiro, PhD
      • Contact: Barbara Plitnick; Phone Number: 518-242-4603; Email: barbara.plitnick@mountsinai.org
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Mariana Figueiro, PhD
      • Contact: Barbara Plitnick; Phone Number: 518-242-4603; Email: barbara.plitnick@mountsinai.org

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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
Depression using the Cornell Scale for Depression in Dementia (CSDD)	The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs (anxiety, sadness, irritability), behavioral disturbances (agitation, loss of interest), physical signs (loss of appetite, weight loss), cyclic functions (mood variation, sleep quality), and ideational disturbances. Scores range from 0 to 38 with a higher score indicating greater depression.	up to week 14
Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)	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 14
Light measurements using the Daysimeter	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 14
Cognitive status Using the Montreal Cognitive Assessment (MOCA)	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 14

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 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): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dyssomnias; Parasomnias; Dementia; Alzheimer Disease
• Other Study ID Numbers: STUDY-20-01736

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