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

NCT ID: NCT05837819

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

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active Lighting Intervention

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

Group Type ACTIVE_COMPARATOR

Active Lighting Intervention

Intervention Type DEVICE

Lighting intervention using high light levels designed to effect the circadian system

Control Lighting Intervention

Intervention Type DEVICE

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

Control Lighting Intervention

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

Group Type PLACEBO_COMPARATOR

Control Lighting Intervention

Intervention Type DEVICE

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

Interventions

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Active Lighting Intervention

Lighting intervention using high light levels designed to effect the circadian system

Intervention Type DEVICE

Control Lighting Intervention

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

Intervention Type DEVICE

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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Albany, New York, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY-20-01736 Aim 2

Identifier Type: -

Identifier Source: org_study_id

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