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Lighting for Older Adults With Dementia

Primary Purpose

Sleep, Mood

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic Lighting
Placebo Lighting
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep focused on measuring Dynamic Lighting, Sleep, Mood, Dementia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: -

Sites / Locations

  • Sunshine Village
  • ASU DeSmart Lab
  • Mirabella at ASU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo Condition followed by Dynamic Condition

Dynamic Condition followed by Placebo Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2023
Last Updated
July 19, 2023
Sponsor
Arizona State University
Collaborators
Arizona Alzheimer's Consortium, Arizona State University Knowledge Enterprise
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1. Study Identification

Unique Protocol Identification Number
NCT05697757
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
Arizona Alzheimer's Consortium, Arizona State University Knowledge Enterprise

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Mood
Keywords
Dynamic Lighting, Sleep, Mood, Dementia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Condition followed by Dynamic Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Dynamic Condition followed by Placebo Condition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dynamic Lighting
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Lighting
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Nocturnal Sleep Duration (in minutes) as measured by actigraphy
Description
Nocturnal Sleep Duration (in minutes) will be measured by Actigraphy. Longer sleep duration corresponds to improved sleep outcomes.
Time Frame
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.
Title
Change in Percent Sleep Efficiency (total sleep time divided by time in bed) measured by actigraphy.
Description
Percent Sleep Efficiency will be measured by actigraphy. Higher percentage corresponds to higher sleep quality.
Time Frame
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.
Title
Minutes of wake after sleep onset measured by actigraphy.
Description
Minutes of wake after sleep onset will be measured by actigraphy. Lower number indicates better sleep pattern and sleep outcomes.
Time Frame
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.
Title
Changes in depression levels as measured by Cornell Scale of Depression in Dementia (CSDD).
Description
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.
Time Frame
Every seven days throughout the 7-week protocol.
Title
Changes in agitation levels measured by Cohen-Mansfield Agitation Inventory (CMAI).
Description
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.
Time Frame
Every seven days throughout the 7-week protocol.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Sharp, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunshine Village
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
ASU DeSmart Lab
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Mirabella at ASU
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
No individual participant data will be shared. Results will be published by the investigators in academic journals and conference proceedings. However, neither the name nor identity of the participants will be used in any publications. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in human-light interactions.
IPD Sharing 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

Learn more about this trial

Lighting for Older Adults With Dementia

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