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

July 2, 2026 updated by: Mariana Figueiro, Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Menands, New York, United States, 12204
        • Light and Health Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Active lighting intervention
Lighting intervention designed to impact the circadian system
Device: Control lighting intervention
Lighting intervention designed to have no impact on the circadian system
Active Comparator: 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.
Device: Active lighting intervention
Lighting intervention designed to impact the circadian system
Device: Control lighting intervention
Lighting intervention designed to have no impact on the circadian system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Disturbance Using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and post intervention (8 weeks)
The Pittsburgh Sleep Quality Index (PSQI) is composed of 19 items that generate 7 component scores. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A global score >5 is considered to indicate sleep disturbances. A lower global score indicates improvement in sleep disturbance.
Baseline and post intervention (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Screening Utilizing the Cornell Scale for Depression in Dementia (CSDD)
Time Frame: Baseline and post intervention (8 weeks)
The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs. Scores range from 0 to 38 with a higher score indicating higher depressive symptoms.
Baseline and post intervention (8 weeks)
Sleep Efficiency Measured by Actigraphy
Time Frame: Baseline and post intervention (8 weeks)
Sleep efficiency is calculated from the wrist worn actigraph by the software program as the percentage of the time in bed spent sleeping. The ratio of total sleep time (TST) to total time in bed (TIB) multiplied by 100 to yield a percentage.
Baseline and post intervention (8 weeks)
Sleep Burden Using The Sleep Disorders Inventory (SDI)
Time Frame: Baseline and post intervention (8 weeks)
Full scale from 0 to 56, with higher score indicating greater sleep disturbance
Baseline and post intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Mariana Figueiro, PhD, Mount Sinai Icahn School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-20-01772
  • R01AG034157 (U.S. NIH Grant/Contract)
  • R44AG060857 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Since this data collection occurs in a population with Alzheimer's disease, participants are generally not interested in individual results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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