Trial Outcomes & Findings for Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia (NCT NCT05519137)
NCT ID: NCT05519137
Last Updated: 2026-07-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Baseline and post intervention (8 weeks)
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (8 Weeks)
STARTED
|
8
|
6
|
|
First Intervention (8 Weeks)
COMPLETED
|
7
|
5
|
|
First Intervention (8 Weeks)
NOT COMPLETED
|
1
|
1
|
|
Washout Period (4 Weeks)
STARTED
|
7
|
5
|
|
Washout Period (4 Weeks)
COMPLETED
|
7
|
5
|
|
Washout Period (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (8 Weeks)
STARTED
|
7
|
5
|
|
Second Intervention (8 Weeks)
COMPLETED
|
1
|
0
|
|
Second Intervention (8 Weeks)
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (8 Weeks)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia
Baseline characteristics by cohort
| Measure |
Active Lighting Intervention Then Control Lighting Condition
n=8 Participants
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
n=6 Participants
Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
82.8 years
STANDARD_DEVIATION 10.2 • n=20 Participants
|
86.2 years
STANDARD_DEVIATION 7.1 • n=20 Participants
|
84.2 years
STANDARD_DEVIATION 8.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Lighting Intervention
n=11 Participants
The lighting in each space will be controlled by a programmable digital system that is configured to deliver the "active" CS schedule throughout the day, with high CS delivered in the morning/daytime hours (until 6pm), and low CS levels in the evening/nighttime. The lighting in each space will be programmed with the "active" CS schedule.
|
Control Lighting
n=11 Participants
The lighting in each space will be controlled by a programmable digital system that is configured to deliver the "control" CS schedule throughout the day. The lighting in each space will be programmed with the "control" schedule wherein the lighting is set to be below the threshold for circadian activation throughout the daytime and nighttime.
|
|---|---|---|
|
Sleep Disturbance Using the Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
6.5 Score on a scale
Standard Deviation 4.3
|
4 Score on a scale
Standard Deviation 2.3
|
|
Sleep Disturbance Using the Pittsburgh Sleep Quality Index (PSQI)
After intervention (8 weeks)
|
4.1 Score on a scale
Standard Deviation 2.3
|
6 Score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Lighting Intervention
n=11 Participants
The lighting in each space will be controlled by a programmable digital system that is configured to deliver the "active" CS schedule throughout the day, with high CS delivered in the morning/daytime hours (until 6pm), and low CS levels in the evening/nighttime. The lighting in each space will be programmed with the "active" CS schedule.
|
Control Lighting
n=11 Participants
The lighting in each space will be controlled by a programmable digital system that is configured to deliver the "control" CS schedule throughout the day. The lighting in each space will be programmed with the "control" schedule wherein the lighting is set to be below the threshold for circadian activation throughout the daytime and nighttime.
|
|---|---|---|
|
Depression Screening Utilizing the Cornell Scale for Depression in Dementia (CSDD)
Baseline
|
12 score on a scale
Standard Deviation 4.3
|
9 score on a scale
Standard Deviation 4.3
|
|
Depression Screening Utilizing the Cornell Scale for Depression in Dementia (CSDD)
Post intervention (8 weeks)
|
9.5 score on a scale
Standard Deviation 2.1
|
9 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Lighting Intervention
n=11 Participants
The lighting in each space will be controlled by a programmable digital system that is configured to deliver the "active" CS schedule throughout the day, with high CS delivered in the morning/daytime hours (until 6pm), and low CS levels in the evening/nighttime. The lighting in each space will be programmed with the "active" CS schedule.
|
Control Lighting
n=11 Participants
The lighting in each space will be controlled by a programmable digital system that is configured to deliver the "control" CS schedule throughout the day. The lighting in each space will be programmed with the "control" schedule wherein the lighting is set to be below the threshold for circadian activation throughout the daytime and nighttime.
|
|---|---|---|
|
Sleep Efficiency Measured by Actigraphy
Baseline
|
81 percentage
Standard Deviation 6.6
|
74.5 percentage
Standard Deviation 5.2
|
|
Sleep Efficiency Measured by Actigraphy
Post intervention (8 weeks)
|
79 percentage
Standard Deviation 6.5
|
71.6 percentage
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline and post intervention (8 weeks)Full scale from 0 to 56, with higher score indicating greater sleep disturbance
Outcome measures
| Measure |
Active Lighting Intervention
n=11 Participants
The lighting in each space will be controlled by a programmable digital system that is configured to deliver the "active" CS schedule throughout the day, with high CS delivered in the morning/daytime hours (until 6pm), and low CS levels in the evening/nighttime. The lighting in each space will be programmed with the "active" CS schedule.
|
Control Lighting
n=11 Participants
The lighting in each space will be controlled by a programmable digital system that is configured to deliver the "control" CS schedule throughout the day. The lighting in each space will be programmed with the "control" schedule wherein the lighting is set to be below the threshold for circadian activation throughout the daytime and nighttime.
|
|---|---|---|
|
Sleep Burden Using The Sleep Disorders Inventory (SDI)
Baseline
|
7.6 score on a scale
Standard Deviation 1.3
|
2 score on a scale
Standard Deviation 1.4
|
|
Sleep Burden Using The Sleep Disorders Inventory (SDI)
Post intervention (8 weeks)
|
3.7 score on a scale
Standard Deviation 1.3
|
7.5 score on a scale
Standard Deviation 0.7
|
Adverse Events
Active Lighting Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Lighting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Phone: (518) 366-9306
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place