NCT06595030

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

Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 3

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	Active Lighting Intervention	The TLI will allow researchers to use a light source that will control how the circadian system is stimulated and provide the participants with options as to how the light treatment will be delivered.
DEVICE	Control Lighting Intervention	The TLI will allow 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.

Timeline

• Start date: 2024-12-03
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2024-09-19
• Last updated: 2026-02-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study