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

Mount Sinai Health System

Status: Completed

Conditions: Alzheimer's Disease; Sleep Disturbance

Treatments: Device: Control Lighting Intervention; Device: Active Lighting Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05837819

STUDY-20-01736 Aim 2

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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135 participants in 2 patient groups, including a placebo group

Active Lighting Intervention

Active Comparator group

Description:

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

Treatment:

Device: Control Lighting Intervention

Device: Active Lighting Intervention

Control Lighting Intervention

Placebo Comparator group

Description:

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

Treatment:

Device: Control Lighting Intervention