Trial Outcomes & Findings for Smart Lighting for Nursing Home Residents With Dementia (NCT NCT05825404)
NCT ID: NCT05825404
Last Updated: 2025-08-08
Results Overview
Average Lux during Intervention and Control Periods at the facility level This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.
COMPLETED
NA
51 participants
Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.
2025-08-08
Participant Flow
This is a clustered cross-over RCT design; all participants will be in the intervention and control groups. The study period is 13 weeks, and the sequences were randomly assigned as follows: Nursing Home A: Baseline (week 1), SABL (weeks 2-5), post-SABL/washout (weeks 6-7), control/usual light (weeks 8-11), and post control (weeks 12-13). Nursing Home B: Baseline (week 1), control/usual light (weeks 2-5), post-control/washout (weeks 6-7), SABL (weeks 8-11), and post intervention (weeks 12-13).
Unit of analysis: Nursing home facility
Participant milestones
| Measure |
Smart Ambient Bright Light, Then Usual Light
The residents received Smart Ambient Bright Light (weeks 2-5) followed by Usual Light (weeks 8-11) with two weeks of washout period in between (weeks 6-7).
This is a cluster cross-over RCT design. Two participating nursing homes will be randomly assigned to two study sequences (one site will begin with the intervention period first followed by the control period while the other site will begin with the control period followed by the intervention period). All sites and all participants will be invited to the intervention and control group
The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting incorporating natural daylight.
Smart Ambient Bright Light (SABL): The Proposed Smart Ambient Bright Light (SABL) includes tunable LED lights, photosensors, and controllers. The SABL will provide bright light targeted at 400 lux and CS=0.3 in participant bedrooms and designated areas such as the dining room and activity room during the day and provide dim light ≤40 lux and CS≤0.1 in participant bedrooms at night.
Control: usual light
|
Usual Light, Then Smart Ambient Bright Light
The residents received usual light first (weeks 2-5) followed by Smart Ambient Bright Light (weeks 8-11) with two weeks of washout period in between (weeks 6-7).
|
|---|---|---|
|
Baseline (Week 1)
STARTED
|
16 1
|
13 1
|
|
Baseline (Week 1)
COMPLETED
|
16 1
|
13 1
|
|
Baseline (Week 1)
NOT COMPLETED
|
0 0
|
0 0
|
|
First Intervention (Weeks 2-5)
STARTED
|
16 1
|
13 1
|
|
First Intervention (Weeks 2-5)
COMPLETED
|
16 0
|
12 1
|
|
First Intervention (Weeks 2-5)
NOT COMPLETED
|
0 1
|
1 0
|
|
Washout (Weeks 6-7)
STARTED
|
16 1
|
12 1
|
|
Washout (Weeks 6-7)
COMPLETED
|
16 1
|
12 1
|
|
Washout (Weeks 6-7)
NOT COMPLETED
|
0 0
|
0 0
|
|
Second Intervention (Weeks 8-11)
STARTED
|
16 1
|
12 1
|
|
Second Intervention (Weeks 8-11)
COMPLETED
|
16 1
|
11 1
|
|
Second Intervention (Weeks 8-11)
NOT COMPLETED
|
0 0
|
1 0
|
|
Follow up (Weeks 12-13)
STARTED
|
16 1
|
11 1
|
|
Follow up (Weeks 12-13)
Intervention Feasibility, Acceptability, and Appropriateness From Stakeholder Perspectives
|
11 1
|
11 1
|
|
Follow up (Weeks 12-13)
COMPLETED
|
16 1
|
11 1
|
|
Follow up (Weeks 12-13)
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Smart Ambient Bright Light, Then Usual Light
The residents received Smart Ambient Bright Light (weeks 2-5) followed by Usual Light (weeks 8-11) with two weeks of washout period in between (weeks 6-7).
This is a cluster cross-over RCT design. Two participating nursing homes will be randomly assigned to two study sequences (one site will begin with the intervention period first followed by the control period while the other site will begin with the control period followed by the intervention period). All sites and all participants will be invited to the intervention and control group
The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting incorporating natural daylight.
Smart Ambient Bright Light (SABL): The Proposed Smart Ambient Bright Light (SABL) includes tunable LED lights, photosensors, and controllers. The SABL will provide bright light targeted at 400 lux and CS=0.3 in participant bedrooms and designated areas such as the dining room and activity room during the day and provide dim light ≤40 lux and CS≤0.1 in participant bedrooms at night.
Control: usual light
|
Usual Light, Then Smart Ambient Bright Light
The residents received usual light first (weeks 2-5) followed by Smart Ambient Bright Light (weeks 8-11) with two weeks of washout period in between (weeks 6-7).
|
|---|---|---|
|
First Intervention (Weeks 2-5)
Death
|
0
|
1
|
|
Second Intervention (Weeks 8-11)
Death
|
0
|
1
|
Baseline Characteristics
Smart Lighting for Nursing Home Residents With Dementia
Baseline characteristics by cohort
| Measure |
Resident Participants
n=27 Participants
This is a cross-over RCT. All participants are invited to participate in the intervention and control.
The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting that incorporates natural daylight.
Smart Ambient Bright Light (SABL): The Proposed Smart Ambient Bright Light (SABL) includes tunable LED lights, photosensors, and controllers. The SABL will provide bright light targeted at 400 lux and CS=0.3 in participant bedrooms and designated areas such as the dining room and activity room during the day and provide dim light ≤40 lux and CS≤0.1 in participant bedrooms at night
Usual light This is a cross-over RCT. All participants will participate in the intervention and control.
|
Stakeholder/Staff Participants
n=22 Participants
At the end of the intervention, we enrolled nursing home stakeholders, including certified nursing assistants, activity staff, nurses, directors of nursing, maintenance, and administrators. 22 participants (11 from each NH)
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
87.4 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
68.1 years
STANDARD_DEVIATION 23.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.Average Lux during Intervention and Control Periods at the facility level This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=2 Nursing Home Site
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
n=2 Nursing Home Site
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Average Lux During Intervention and Control Periods at the Facility Level
|
394.2 Lux
Standard Deviation 49.70
|
97.4 Lux
Standard Deviation 23.82
|
PRIMARY outcome
Timeframe: Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.Light CS level at the facility level was measured manually on-site. This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=2 Nursing home site
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
n=2 Nursing home site
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Facility Level
|
0.302 CS
Standard Deviation 0.07
|
0.097 CS
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.Light level (lux) at the individual level will be measured using a personal light monitor. This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=2 Nursing Home Site
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
n=2 Nursing Home Site
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Average Lux During Intervention and Control Periods at the Individual Level
|
406.89 Lux
Standard Deviation 102.35
|
286.69 Lux
Standard Deviation 83.50
|
PRIMARY outcome
Timeframe: Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=2 Nursing Home Site
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
n=2 Nursing Home Site
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Individual Level
|
0.36 CS
Standard Deviation 0.09
|
0.24 CS
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: Intervention: Intervention first group: difference of weeks 1 & 5; Control first group: difference of weeks 7 & 11 Control: Intervention first group: difference of weeks 7 & 11; Control first group: difference of weeks 1 & 5Agitation was measured using Cohen-Mansfield Agitation Inventory (CMAI) in weeks 1, 3, 5, 7, 9, 11, 13. Total scores range from 29-203; higher scores, more agitation. For the intervention, data were the difference between week 1 (pre-intervention) and week 5 (during intervention) for the intervention first group, and data were the difference between weeks 7 (pre-intervention) and week 11 (during intervention) for the control first group. For the control, data were the difference between week 7 (pre-control) and week 11 (during control) for the intervention first group, and data were the difference between week 1 (pre-intervention) and week 5 (during intervention) for the control first group.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=2 Nursing Home Site
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
n=2 Nursing Home Site
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Change in Agitation During the Intervention and Control Periods
|
-4.78 Score on the scale
Standard Deviation 13.55
|
-1.48 Score on the scale
Standard Deviation 13.05
|
PRIMARY outcome
Timeframe: Week 13The intervention acceptability of the lighting intervention were measured based on nursing home stakeholders' perspectives using the Acceptability of Intervention Measure (AIM) and followed up by qualitative interviews. The score ranges from 1-5; a higher score indicates a higher level of acceptability.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=22 Participants
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Intervention Acceptability
|
4.10 score on a scale
Standard Deviation 0.93
|
—
|
PRIMARY outcome
Timeframe: Week 13The intervention feasibility of the lighting intervention will be measured based on nursing home stakeholders' perspectives using the Feasibility of Intervention Measure (FIM) and followed up by qualitative interviews. The total score ranges from 1-5; a higher score indicates a higher level of feasibility.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=22 Participants
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Intervention Feasibility
|
4.40 score on a scale
Standard Deviation 0.51
|
—
|
PRIMARY outcome
Timeframe: Week 13The appropriateness of the lighting intervention will be measured based on nursing home stakeholders' perspectives using the Intervention Appropriateness Measure (IAM) and followed up by qualitative interviews. The total score ranges from 1-5; a higher score indicates a higher level of appropriateness.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=22 Participants
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Intervention Appropriateness
|
3.99 score on a scale
Standard Deviation 0.74
|
—
|
SECONDARY outcome
Timeframe: Intervention: Intervention first group: difference of weeks 1 & 5; Control first group: difference of weeks 7 & 11 Control: Intervention first group: difference of weeks 7 & 11; Control first group: difference of weeks 1 & 5BPSD were measured via the Neuropsychiatry Inventory, including delusions, hallucinations, dysphoria, euphoria, anxiety, agitation, apathy, irritability, disinhibition, aberrant motor behaviors, sleep, and appetite. Each symptom score ranges from 0-12, higher scores more severe. Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13 Intervention: the difference between weeks 1 (pre-intervention) and 5 (during intervention) for the intervention first group, and the difference between weeks 7 (pre-intervention) and 11 (during intervention) for the control first group. Control: the difference between weeks 7 (pre-control) and week 11 (during control) for the intervention first group, and the difference between weeks 1 (pre-control) and 5 (during control) for the control first group.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=2 Nursing Home Site
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
n=2 Nursing Home Site
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Agitation
|
-1.11 units on a scale
Standard Deviation 3.88
|
-0.07 units on a scale
Standard Deviation 3.44
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Anxiety
|
-1.15 units on a scale
Standard Deviation 3.42
|
0.30 units on a scale
Standard Deviation 3.77
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Apathy
|
-1.04 units on a scale
Standard Deviation 3.41
|
0.07 units on a scale
Standard Deviation 2.83
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Appetite
|
-1.70 units on a scale
Standard Deviation 3.54
|
0.63 units on a scale
Standard Deviation 1.98
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Delusion
|
-1.70 units on a scale
Standard Deviation 4.72
|
0.48 units on a scale
Standard Deviation 3.79
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Depression
|
-1.59 units on a scale
Standard Deviation 4.43
|
0.15 units on a scale
Standard Deviation 2.33
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Disinhibition
|
-1.74 units on a scale
Standard Deviation 3.57
|
-0.52 units on a scale
Standard Deviation 2.62
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Elation
|
-0.52 units on a scale
Standard Deviation 2.71
|
-0.52 units on a scale
Standard Deviation 1.53
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Hallucinations
|
-1.15 units on a scale
Standard Deviation 3.24
|
0.19 units on a scale
Standard Deviation 1.73
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Irritability
|
-0.48 units on a scale
Standard Deviation 3.92
|
-0.30 units on a scale
Standard Deviation 3.07
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Motor behaviors
|
-0.78 units on a scale
Standard Deviation 3.15
|
-1.11 units on a scale
Standard Deviation 4.36
|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Sleep
|
-2.04 units on a scale
Standard Deviation 3.37
|
0.74 units on a scale
Standard Deviation 3.50
|
SECONDARY outcome
Timeframe: Intervention: Intervention first group: difference of weeks 1 & 5; Control first group: difference of weeks 7 & 11 Control: Intervention first group: difference of weeks 7 & 11; Control first group: difference of weeks 1 & 5Six affects were measured: contentment, interest, pleasure, anxiety/fear, anger, and sadness, using the Philadelphia Geriatric Center Affect Rating Scale. Each affect score ranges from 1 to 5; higher scores, higher levels. Two nursing homes were randomly assigned to different sequences; one nursing home began with intervention (weeks 2-5), followed by control (weeks 8-11), while the other nursing home began with control (weeks 2-5), followed by intervention (weeks 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Intervention: the difference between weeks 1 (pre-intervention) and 5 (during intervention) for the intervention first group, and the difference between weeks 7 (pre-intervention) and 11 (during intervention) for the control first group. Control: the difference between weeks 7 (pre-control) and 11 (during control) for the intervention first group, and the difference between weeks 1 (pre-intervention) and 5 (during intervention) for the control first group.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=2 Nursing Home Site
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
n=2 Nursing Home Site
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Affect
Contentment
|
0.22 score on a scale
Standard Deviation 1.09
|
0.56 score on a scale
Standard Deviation 1.09
|
|
Affect
Interest
|
0.26 score on a scale
Standard Deviation 1.20
|
0.48 score on a scale
Standard Deviation 1.09
|
|
Affect
Pleasure
|
0.15 score on a scale
Standard Deviation 1.20
|
0.44 score on a scale
Standard Deviation 1.15
|
|
Affect
Anger
|
0 score on a scale
Standard Deviation 0.88
|
0.19 score on a scale
Standard Deviation 1.08
|
|
Affect
Fear
|
0.04 score on a scale
Standard Deviation 1.22
|
-0.15 score on a scale
Standard Deviation 1.32
|
|
Affect
Sadness
|
-0.19 score on a scale
Standard Deviation 1.14
|
0.00 score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Weeks 1-13 combinedData on intervention-related adverse effects will be collected via inputs from certified nurse assistants (CNAs) using a checklist, which includes deteriorated BPSDs, skin rash, eye irritation, dizziness, nausea, or any other reactions. Each item will be checked as yes or no. Data were collected at weeks 1, 3, 5, 7, 9, 11, and 13. Data across all weeks was combined.
Outcome measures
| Measure |
Intervention: Smart Ambient Bright Light
n=2 Nursing Home Site
All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11).
|
Control: Usual Light
n=2 Nursing Home Site
All residents received the Usual Light either during weeks 2-5 or weeks 8-11.
|
|---|---|---|
|
Adverse Effects.
|
0 participants
|
0 participants
|
Adverse Events
Smart Ambient Bright Light
Usual Light
Serious adverse events
| Measure |
Smart Ambient Bright Light
n=29 participants at risk
This is a cluster crossover RCT design. Two nursing homes will be randomly assigned into two different sequences; one site will begin with the intervention period, followed by the control period, while the other site will begin with the control period, followed by the intervention period.
Intervention: Smart Ambient Bright Light (SABL)
|
Usual Light
n=29 participants at risk
Control: Usual light
|
|---|---|---|
|
Nervous system disorders
Death
|
3.4%
1/29 • Number of events 1 • Weeks 1, 3, 5, 7, 9, 11, 13
|
3.4%
1/29 • Number of events 1 • Weeks 1, 3, 5, 7, 9, 11, 13
|
Other adverse events
| Measure |
Smart Ambient Bright Light
n=29 participants at risk
This is a cluster crossover RCT design. Two nursing homes will be randomly assigned into two different sequences; one site will begin with the intervention period, followed by the control period, while the other site will begin with the control period, followed by the intervention period.
Intervention: Smart Ambient Bright Light (SABL)
|
Usual Light
n=29 participants at risk
Control: Usual light
|
|---|---|---|
|
General disorders
Nausea
|
3.4%
1/29 • Weeks 1, 3, 5, 7, 9, 11, 13
|
0.00%
0/29 • Weeks 1, 3, 5, 7, 9, 11, 13
|
|
General disorders
Pneumonia
|
3.4%
1/29 • Weeks 1, 3, 5, 7, 9, 11, 13
|
0.00%
0/29 • Weeks 1, 3, 5, 7, 9, 11, 13
|
|
General disorders
Urinary tract infection
|
3.4%
1/29 • Weeks 1, 3, 5, 7, 9, 11, 13
|
0.00%
0/29 • Weeks 1, 3, 5, 7, 9, 11, 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place