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

Mount Sinai Health System

Status: Enrolling

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06595030

STUDY-20-01736 Aim 3

5R01AG034157-13 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 55+ 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: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Active Lighting Intervention

Active Comparator group

Description:

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.

Treatment:

Device: Active Lighting Intervention

Control Lighting Intervention

Placebo Comparator group

Description:

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.

Treatment:

Device: Control Lighting Intervention