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

NCT05837819 | Completed

• 1 other identifier: STUDY-20-01736 Aim 2
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Alzheimer's Disease; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sleep efficiency using actigraphy

  up to week 14

Study Arms (2)

Active Lighting Intervention

ACTIVE COMPARATOR

Lighting intervention designed to effect the circadian system then will receive the control lighting intervention.

Device: Active Lighting Intervention; Device: Control Lighting Intervention

Control Lighting Intervention

PLACEBO COMPARATOR

Lighting intervention using low light levels designed to not effect the circadian system

Device: Control Lighting Intervention

Interventions

Active Lighting Intervention DEVICE

Lighting intervention using high light levels designed to effect the circadian system

Active Lighting Intervention

Control Lighting Intervention DEVICE

Lighting intervention using low light levels designed to not effect the circadian system

Active Lighting Intervention; Control Lighting Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Icahn School of Medicine at Mount Sinai

Albany, New York, 12204, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Parasomnias

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders

Study Officials

• Mariana Figueiro, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: February 14, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)