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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active lighting intervention

Device

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

Control lighting intervention

Device

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

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: May 1, 2023
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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