- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05825404
Smart Lighting for Nursing Home Residents With Dementia
The Effect of Smart Ambient Bright Light for Nursing Home Residents With Alzheimer's Disease and Related Dementias
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Belleville, Pennsylvania, United States, 17004
- Valley View Retirement Community
-
DuBois, Pennsylvania, United States, 15801
- Christ the King Manor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Resident participants
Inclusion Criteria:
- Age≥55
- English speaking
- Nursing home residency≥3 months
- Clinical Diagnosis of Alzheimer's Disease and related dementia
- Presence of agitation over the past week
Exclusion Criteria:
- Major sleep problems
- Major mental illness
- Severe vision impairment
- Severe acute or terminal illness
Staff participants:
Inclusion criteria:
- Age≥18
- English speaking
- Employed as a certified nurse assistant (CNA), activity staff, nurse, director of nursing (DON), director of maintenance, administer or other leadership position for at least 3 months. The CNA, activity staff, and nurse must have direct care interactions with the resident participant(s).
Study Plan
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 |
|---|---|
|
Experimental: Smart ambient bright light
The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting that incorporates natural daylight.
|
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
|
|
Sham Comparator: Control
Usual light.
|
Usual light.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Lux During Intervention and Control Periods at the Facility Level
Time Frame: 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. |
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 Circadian Stimulation (CS) Level During Intervention and Control Periods at the Facility Level
Time Frame: 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. |
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 Individual Level
Time Frame: 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. |
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 Circadian Stimulation (CS) Level During Intervention and Control Periods at the Individual Level
Time Frame: 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. |
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.
|
|
Change in Agitation During the Intervention and Control Periods
Time Frame: 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 & 5
|
Agitation 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. |
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 & 5
|
|
Intervention Acceptability
Time Frame: Week 13
|
The 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.
|
Week 13
|
|
Intervention Feasibility
Time Frame: Week 13
|
The 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.
|
Week 13
|
|
Intervention Appropriateness
Time Frame: Week 13
|
The 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.
|
Week 13
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral and Psychological Symptoms of Dementia (BPSD)
Time Frame: 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 & 5
|
BPSD 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. |
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 & 5
|
|
Affect
Time Frame: 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 & 5
|
Six 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. |
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 & 5
|
|
Adverse Effects.
Time Frame: Weeks 1-13 combined
|
Data 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.
|
Weeks 1-13 combined
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ying-Ling Jao, PhD, Penn State University
Publications and helpful links
General Publications
- Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8.
- Figueiro MG, Hunter CM, Higgins P, Hornick T, Jones GE, Plitnick B, Brons J, Rea MS. Tailored Lighting Intervention for Persons with Dementia and Caregivers Living at Home. Sleep Health. 2015 Dec 1;1(4):322-330. doi: 10.1016/j.sleh.2015.09.003.
- Jao YL, Wang J, Liao YJ, Parajuli J, Berish D, Boltz M, Van Haitsma K, Wang N, McNally L, Calkins M. Effect of Ambient Bright Light on Behavioral and Psychological Symptoms in People With Dementia: A Systematic Review. Innov Aging. 2022 Mar 24;6(3):igac018. doi: 10.1093/geroni/igac018. eCollection 2022.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00020216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Alzheimer's Disease and Related Dementias
-
University of IowaNational Institute on Aging (NIA)Completed
-
Northwell HealthNational Institute of Nursing Research (NINR); Penn State UniversityCompletedAlzheimer's Disease and Related DementiasUnited States
-
Rutgers, The State University of New JerseyNational Institute on Aging (NIA)Completed
-
Icahn School of Medicine at Mount SinaiNational Institute on Aging (NIA)Completed
-
Northwell HealthNational Institute of Nursing Research (NINR); Penn State UniversityCompletedAlzheimer's Disease and Related DementiasUnited States
-
Harvard Pilgrim Health CareNational Institute on Aging (NIA); Tufts Health PlanCompletedAlzheimer's Disease and Related Dementias (ADRD)United States
-
Arizona State UniversityRecruitingAlzheimer's Disease and Related Dementias Family CaregiversUnited States
-
Florida State UniversityNational Institute of Nursing Research (NINR)CompletedAlzheimer's Disease and Related DementiasUnited States
-
University of South FloridaNational Institute on Aging (NIA)RecruitingAge-related Cognitive Decline | Alzheimer's Disease and Related DementiasUnited States
-
University of Colorado, DenverRecruitingHospice | Alzheimer's Disease and Related Dementias | Sexual and Gender MinoritiesUnited States
Clinical Trials on Smart Ambient Bright Light (SABL)
-
Rebecca E Kotcher, MDNational Institutes of Health (NIH); National Institute of General Medical... and other collaboratorsRecruitingPain, Acute | Rib FracturesUnited States
-
China Medical University HospitalCompletedPhotobiomodulationTaiwan
-
University of ArizonaU.S. Army Medical Research Acquisition ActivityCompletedConcussion, Mild | Sleep Problems | Post-Concussion SymptomsUnited States
-
Matthew Neal MDTerminatedPancreatic Neoplasms | Rectal NeoplasmsUnited States
-
University of ArizonaU.S. Army Medical Research Acquisition ActivityCompletedConcussion, Mild | Sleep Problems | Post-Concussion SymptomsUnited States
-
Radford UniversityCommonwealth Care of Roanoke, Inc.; Virginia Center on Aging (ARDRAF)Completed
-
Yale UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedCircadian Rhythm Sleep Disorder, UnspecifiedUnited States
-
University of BergenCompleted
-
Shanghai Zhongshan HospitalFudan University; Shanghai Mental Health Center, Jingan District; Shanghai Mental...Unknown
-
National Eye Institute (NEI)CompletedRetinopathy of PrematurityUnited States