Smart Lighting for Nursing Home Residents With Dementia

NCT05825404 | Completed Results FDA Device

• 1 other identifier: STUDY00020216
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

This proposed study seeks to develop a smart ambient bright light (SABL) intervention to provide auto-controlled, consistent indoor lighting that incorporates natural daylight. This SABL includes tunable LED lights, photosensors, and controllers. The SABL system has a pre-programmed 24-hour control schedule for illuminance settings to mimic the natural bright-dark cycle. It will automatically adjust the lights to accommodate the daylight effect to minimize staff burden and maximize the LI effect. The SABL will be installed in participants' bedrooms and designated areas in the dining rooms and activity rooms for four weeks. Each participant will wear a personal light monitor to measure the lighting dosage each participant receives. This study will address three aims: 1) pilot test the effect of SABL on reducing agitation in persons with ADRD, 2) evaluate the fidelity of the SABL delivery, and 3) evaluate the feasibility of implementing the SABL. The study will be conducted in two NHs in Pennsylvania. For aims 1 and 2, the investigators will use a crossover, cluster randomized control trial (RCT) and will enroll residents with ADRD and agitation. For aim 3, the investigators will use a mixed methods design and will interview NH stakeholders to evaluate the acceptability, feasibility, and appropriateness of the intervention. This is the first study that incorporates daylight in ambient light interventions and the first study that addresses the measurement, feasibility, and fidelity of lighting interventions. Findings will establish evidence-based implementation strategies and the best design for SABL to reduce agitation for persons with ADRD in NHs.

Conditions

Alzheimer's Disease and Related Dementias

Outcome Measures

Primary Outcomes (8)

• Average Lux During Intervention and Control Periods at the Facility Level

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (3)

• Behavioral and Psychological Symptoms of Dementia (BPSD)

  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

  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.

  Weeks 1-13 combined

Study Arms (2)

Smart ambient bright light

EXPERIMENTAL

The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting that incorporates natural daylight.

Device: Smart Ambient Bright Light (SABL)

Control

SHAM COMPARATOR

Usual light.

Other: Control

Interventions

Smart Ambient Bright Light (SABL) DEVICE

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

Smart ambient bright light

Control OTHER

Usual light.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major sleep problems
• Major mental illness
• Severe vision impairment
• Severe acute or terminal illness
• Staff participants:
• 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).

Sponsors & Collaborators

• Penn State University: lead

Study Sites (2)

Valley View Retirement Community

Belleville, Pennsylvania, 17004, United States

Location

Christ the King Manor

DuBois, Pennsylvania, 15801, United States

Location

Related Publications (3)

• 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.

  PMID: 31855161 BACKGROUND

• 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.

  PMID: 27066526 BACKGROUND

• 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.

  PMID: 35602310 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Ying-Ling Jao
• Organization: Penn State University

yuj15@psu.edu

8148655634

Study Officials

• Ying-Ling Jao, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 29 resident participants participated in randomized controlled trial for testing intervention efficacy. 22 staff participants participated in mixed methods interview for evaluating intervention feasibility.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 24, 2023
• Study Start: April 24, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 5, 2023
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)