Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia

NCT ID: NCT05519137

Last Updated: 2023-06-07

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-06

Study Completion Date

2023-05-01

Brief Summary

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To test the effect of a tailored lighting intervention controlled by the Readings At Desk (RAD) controller on sleep and mood in Alzheimer's disease participants.

Detailed Description

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Each participant will be enrolled for 22 weeks. Participants will be randomly assigned to receive either the active or control lighting condition. Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition. Assessments will be performed before and at the end of each lighting intervention.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will randomly be assigned to initially receive the active or control lighting intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active lighting intervention then Control lighting condition

Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.

Group Type ACTIVE_COMPARATOR

Active lighting intervention

Intervention Type DEVICE

Lighting intervention designed to impact the circadian system

Control lighting intervention

Intervention Type DEVICE

Lighting intervention designed to have no impact on the circadian system

Control lighting condition then Active light intervention

Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.

Group Type ACTIVE_COMPARATOR

Active lighting intervention

Intervention Type DEVICE

Lighting intervention designed to impact the circadian system

Control lighting intervention

Intervention Type DEVICE

Lighting intervention designed to have no impact on the circadian system

Interventions

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Active lighting intervention

Lighting intervention designed to impact the circadian system

Intervention Type DEVICE

Control lighting intervention

Lighting intervention designed to have no impact on the circadian system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19
* a score \>5 on the PSQI.

Exclusion Criteria

\- use of sleep medication
Minimum Eligible Age

60 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

Mount Sinai Icahn School of Medicine

Locations

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Light and Health Research Center

Menands, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY-20-01772

Identifier Type: -

Identifier Source: org_study_id

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