Lighting for Older Adults With Dementia

NCT05697757 | Completed

• 1 other identifier: STUDY00016960
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to investigate the effect of a dynamic lighting intervention on sleep quality, circadian activity rhythms, and mood in older adults with dementia living in long-term care facilities. The dynamic lighting intervention is designed to create an ambient illumination that provides a high level of circadian stimulation in the morning and circadian-neutral lighting in the evenings through delivering varying light intensity and spectrum.

Conditions

Sleep; Mood

Keywords

Dynamic Lighting; Sleep; Mood; Dementia

Outcome Measures

Primary Outcomes (5)

• Change in Nocturnal Sleep Duration (in minutes) as measured by actigraphy

  Nocturnal Sleep Duration (in minutes) will be measured by Actigraphy. Longer sleep duration corresponds to improved sleep outcomes.

  24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.

• Change in Percent Sleep Efficiency (total sleep time divided by time in bed) measured by actigraphy.

  Percent Sleep Efficiency will be measured by actigraphy. Higher percentage corresponds to higher sleep quality.

  24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.

• Minutes of wake after sleep onset measured by actigraphy.

  Minutes of wake after sleep onset will be measured by actigraphy. Lower number indicates better sleep pattern and sleep outcomes.

  24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.

• Changes in depression levels as measured by Cornell Scale of Depression in Dementia (CSDD).

  Depression level is assessed using CSDD every 7 days throughout the 7-week protocol based on caregivers' observations of the participants' behavior during the week prior. Lower scores in CSDD indicates lower depression and better mood outcomes.

  Every seven days throughout the 7-week protocol.

• Changes in agitation levels measured by Cohen-Mansfield Agitation Inventory (CMAI).

  Agitation level is assessed using CMAI every 7 days throughout the 7-week protocol based on caregivers' observations of the participants' behavior during the week prior. A lower score indicates lower levels of agitations and an improvement in mood.

  Every seven days throughout the 7-week protocol.

Study Arms (2)

Placebo Condition followed by Dynamic Condition

EXPERIMENTAL

Each lighting condition will last for three weeks (Weeks 2-4 or 5-7). The order of conditions will be randomized. Sleep data will be collected only on the last 7 days of each condition using actigraphy. Light spectrum and intensity will be tracked continuously throughout the waking hours (wearable light tracker). Moreover, caregivers will complete two questionnaires (CSDD and CMAI) every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants.

Other: Dynamic Lighting; Other: Placebo Lighting

Dynamic Condition followed by Placebo Condition

EXPERIMENTAL

Each lighting condition will last for three weeks (Weeks 2-4 or 5-7). The order of conditions will be randomized. Sleep data will be collected only on the last 7 days of each condition using actigraphy. Light spectrum and intensity will be tracked continuously throughout the waking hours (wearable light tracker). Moreover, caregivers will complete two questionnaires (CSDD and CMAI) every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants.

Other: Dynamic Lighting; Other: Placebo Lighting

Interventions

Dynamic Lighting OTHER

This will be an eighteen-hour lighting scheme that includes three modes: morning (6:00 - 12:00), afternoon (12:00 - 18:00), and evening (18:00 - 24:00). It mimics natural lighting by providing blue-enriched high-intensity lighting in the morning and neutral white medium-intensity lighting in the afternoon to maintain alertness without exerting substantial circadian effects. The biodynamic lighting will provide yellowish low-intensity lighting in the evening to minimize any circadian effect.

Dynamic Condition followed by Placebo Condition; Placebo Condition followed by Dynamic Condition

Placebo Lighting OTHER

We will include an active placebo condition that will be a whole-day lighting scheme with constant color and brightness from morning to evening. The numbers of CCT and illuminance levels are selected based on the average room lighting

Dynamic Condition followed by Placebo Condition; Placebo Condition followed by Dynamic Condition

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 50.
• Diagnosed with mild to major dementia based on the physician and care facility manager's recommendation.
• Has no major organ failure, major diagnosis other than dementia, history of head injury, obstructing cataracts, macular degeneration, and blindness based on their Medical history.
• Not taking light therapy
• Female or male
• No current or planned use of light-altering devices (e.g., blue-blocking and/or tinted glasses and contact lenses)

Sponsors & Collaborators

• Arizona State University: lead
• Arizona Alzheimer's Consortium: collaborator
• Arizona State University Knowledge Enterprise: collaborator

Study Sites (3)

Sunshine Village

Phoenix, Arizona, 85032, United States

Location

ASU DeSmart Lab

Tempe, Arizona, 85281, United States

Location

Mirabella at ASU

Tempe, Arizona, 85281, United States

Location

Related Publications (1)

• Alrahyani M, Youngstedt S, Fani M, Yague N, Yu F, Guest MA, Yeom D, Sharp N. Effects of applying biodynamic lighting on improving sleep, depression, and agitation in older adults with dementia: a pilot clinical trial. Geriatr Nurs. 2025 Jul-Aug;64:103435. doi: 10.1016/j.gerinurse.2025.103435. Epub 2025 Jul 4.

  PMID: 40617163 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nina Sharp, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither participants nor their caregivers will be told about the structure of the lighting conditions and the potential effects, just that the lighting could change daily.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Investigators will examine a series of participants (N=30), each of whom will participate in a seven-week experiment. The study will be conducted over seven successive one-week periods with two cohorts of participants experiencing the same series of lighting interventions in a counterbalanced manner.

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: January 26, 2023
• Study Start: January 13, 2023
• Primary Completion: April 1, 2023
• Study Completion: June 30, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available after the data collection and analysis is complete which is anticipated to be in January 2024. The findings will be published in academic journals

Locations

US (3)