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

NCT06595030 | Completed FDA Device

• 2 other identifiers: STUDY-20-01736 Aim 35R01AG034157-13
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Disturbance using the Pittsburgh Sleep Quality Index (PSQI)

  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 full scale range of 0 to 21. A higher score indicates higher sleep disturbance.

  Up to Week 36

Secondary Outcomes (5)

• Sleep efficiency using actigraphy

  Up to Week 36

• Depression using the Cornell Scale for Depression in Dementia (CSDD)

  Up to Week 36

• Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)

  Up to Week 36

• Light measurements using the Daysimeter

  Up to Week 36

• Cognitive status Using the Montreal Cognitive Assessment (MOCA)

  Up to Week 36

Study Arms (2)

Active Lighting Intervention

ACTIVE COMPARATOR

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.

Device: Active Lighting Intervention

Control Lighting Intervention

PLACEBO COMPARATOR

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.

Device: Control Lighting Intervention

Interventions

Active Lighting Intervention DEVICE

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.

Also known as: TLI

Active Lighting Intervention

Control Lighting Intervention DEVICE

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.

Also known as: TLI

Control Lighting Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), 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
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

Menands, 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; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: December 3, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)