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

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: Alzheimer's Disease
• Intervention / Treatment: Device: Active lighting intervention; Device: Control lighting intervention

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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.	up to 22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression screening utilizing the Cornell Scale for Depression in Dementia (CSDD)	The CSDD is a 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.	up to 22 weeks
Sleep efficiency measured by actigraphy	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.	up to 22 weeks

Collaborators and Investigators

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

Study record dates

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): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: STUDY-20-01772

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