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

NCT ID: NCT06595030

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Lighting Intervention

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.

Group Type ACTIVE_COMPARATOR

Active Lighting Intervention

Intervention Type 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.

Control Lighting Intervention

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.

Group Type PLACEBO_COMPARATOR

Control Lighting Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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TLI TLI

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Mariana Figueiro

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariana Figueiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

Menands, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Barbara Plitnick, BSN

Role: CONTACT

518-242-4603

Mariana Figueiro, PhD

Role: CONTACT

212-241-6500

Facility Contacts

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Barbara Plitnick

Role: primary

518-242-4603

Barbara Plitnick

Role: primary

518-242-4603

Other Identifiers

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5R01AG034157-13

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-20-01736 Aim 3

Identifier Type: -

Identifier Source: org_study_id

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