Clinical trial NCT05697757: Lighting for Older Adults With Dementia
Official title: Effects of Dynamic Lighting on Improving Sleep and Mood in Older Adults With Dementia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Mood
Keywords: Dynamic Lighting
Sleep
Mood
Dementia
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Arizona Alzheimer's Consortium
name: Arizona State University Knowledge Enterprise
First posted: 2023-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: Light is the most important environmental element that is not only necessary to fulfill visual tasks but also is the main stimulus that regulates circadian rhythms. Daily exposure to proper lighting at the right time is reported as an effective non-pharmacological treatment to improve sleep disorders in various age groups including older adults. Several clinical studies have demonstrated the benefits of bright light therapy to improve sleep duration and sleep efficiency at night and reduce daytime sleepiness and behavioral disturbance (i.e., agitation, depression) in older adults. In most of these studies, lighting intervention includes a lightbox that exposes participants to an extra lighting source with specific characteristics (i.e., blue-enriched bright light) for only a few hours without considering the impacts of other lighting sources that individuals are exposed to throughout the day. A significant impediment to administrating bright light therapy for older adults with dementia is that these individuals typically require reminders to remain seated and awake in front of a lightbox long enough to benefit from the bright light exposure. An alternative way to deliver bright light is through providing circadian-effective ambient lighting. The circadian system responds best to high-intensity short-wavelength light (peak wavelength of 480 nm). However, the lighting design in long-term care facilities does not necessarily provide adequate intensity and spectrum to stimulate circadian rhythms in elder residences. Studies reported poor lighting conditions in nursing homes. According to these studies, daytime lighting in these institutions is not even sufficient to fulfill older adults' visual needs, while light at night is relatively often excessive. Thus, this study will be carried out to achieve the following aims:

Aim1: Investigate the effect of a dynamic lighting condition on circadian activity rhythms and selected sleep parameters in older adults with dementia.

Aim2: Evaluate the effect of a dynamic lighting condition on mood.

Findings from this study will provide initial guidance to the designers and administration of memory care facilities as to the lighting design recommendations of greatest benefits to the sleep, mood, and well-being of institutionalized older adults diagnosed with dementia.

The participants will be recruited from two memory care facilities from the greater Phoenix area, based on the recommendation of the managers at the memory care facilities.

Environment: In this study, the human-lighting interaction will occur in the common areas of the selected memory care facilities where older adults with dementia spend most of the daytime hours under the supervision of facility caregivers. Research personnel will install experimental luminaires in the memory care facility's common area. During this visit, research personnel will also give a number of actigraphs and light trackers (which will be used for data collection throughout the study) to caregivers and instruct them on how to use these devices on participants. Participants will also be instructed (by caregivers) on how to use each device.

Week 1 (Baseline): Patterns of sleep, moods, and light exposure will be monitored ad libitum for one week. The experimental luminaires will remain off during Week 1. Placing luminaires in the common area of the facility prior to the use of lighting interventions during Weeks 2 to 7 will minimize environmental variations between baseline and intervention measurements (e.g., new luminaires in the room) and decrease the bias resulting from the Hawthorne effect on collected data.

Weeks 2-7 (Intervention): The intervention period will start right after the baseline and continue for six constructive weeks. There are two lighting interventions, each of which is three weeks long. We will randomly assign one of the residences to start with (Dynamic \> Placebo) lighting intervention while the other start with (Placebo \> Dynamic) lighting intervention. Actigraphy will be conducted only on the last 7 days of each condition. Light spectrum and intensity will be tracked continuously throughout the waking hours (Blue Iris mobile sensor). Moreover, caregivers will complete 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Inclusion Criteria:

-

Primary outcomes:
measure: Change in Nocturnal Sleep Duration (in minutes) as measured by actigraphy
timeFrame: 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.
measure: Change in Percent Sleep Efficiency (total sleep time divided by time in bed) measured by actigraphy.
timeFrame: 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.
measure: Minutes of wake after sleep onset measured by actigraphy.
timeFrame: 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.
measure: Changes in depression levels as measured by Cornell Scale of Depression in Dementia (CSDD).
timeFrame: Every seven days throughout the 7-week protocol.
measure: Changes in agitation levels measured by Cohen-Mansfield Agitation Inventory (CMAI).
timeFrame: Every seven days throughout the 7-week protocol.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Sunshine Village
state: Arizona
city: Tempe
country: United States
facility: ASU DeSmart Lab
state: Arizona
city: Tempe
country: United States
facility: Mirabella at ASU
state: Arizona
Study officials:
affiliation: Arizona State University
name: Nina Sharp, PhD
role: PRINCIPAL_INVESTIGATOR
References: