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

Not Applicable

Completed

• Conditions: Alzheimer's Disease
• Interventions: Device: Active lighting intervention; Device: Control lighting intervention

• Registration Number: NCT05519137
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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

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 Timeline

• Study Start: 2022-01-06
• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-29
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control lighting condition then Active light intervention	Active lighting intervention	Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.
Control lighting condition then Active light intervention	Control lighting intervention	Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.
Active lighting intervention then Control lighting condition	Active lighting intervention	Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.
Active lighting intervention then Control lighting condition	Control lighting intervention	Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.

Primary Outcome Measures

Name	Time	Method
Sleep disturbance using the Pittsburgh Sleep Quality Index	up to 22 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.

Secondary Outcome Measures

Name	Time	Method
Depression screening utilizing the Cornell Scale for Depression in Dementia (CSDD)	up to 22 weeks	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.
Sleep efficiency measured by actigraphy	up to 22 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.

Trial Locations

Locations (1)

Light and Health Research Center; 🇺🇸 Menands, New York, United States