SmartEnLite: A Smart Environmental Lighting Intervention to Improve Behaviors and Sleep for Nursing Home Residents Living With Dementia
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All trials for Alzheimer's Disease and Related Dementias All trials for Alzheimer Disease and Related Dementias All trials of Smart Environmental Light (SmartEnLite)
-Summary
The goal of this clinical trial is to learn if the Smart Environmental Lighting (SmartEnLite) can help improve behaviors and sleep among residents with dementia in nursing homes. The main questions it aims to answer are:
* What is the effect of SmartEnLite on mood and behaviors?
* What is the effect of SmartEnLite on sleep?
* Would the effect of SmartEnLite on sleep affect its effect on mood and behaviors? Researchers will compare the SmartEnLite to the usual light in nursing homes to see if the SmartEnLite works to improve behaviors and sleep in nursing home residents with dementia.
Participants will:
* Participate in the study for 13 weeks with SmartEnLite for 4 weeks and their usual light.
* Wear a sensor for 13 weeks to measure their sleep and light exposure.
* Be observed for mood, behaviors, and reactions to the lights every other week.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Smart Environmental Lighting (SmartEnLite) | Experimental | Device: Smart Environmental Light (SmartEnLite) | |
| Usual Light | No intervention | | |
- Smart Environmental Light (SmartEnLite) (Device), also known as Control: Usual light: The SmartEnLite is designed to automatically provide bright light during the daytime and dim light at night, aiming to support circadian rhythms.
+Outcome measures
Primary outcomes
- Agitation level [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Agitation level will be measured using Cohen-Mansfield Agitation Inventory.
- Depression level [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Depression level will be measured using the Cornell Scale for Depression in Dementia (CSDD)
- Apathy level [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Apathy level will be measured using the Person-Environment Apathy Rating (PEAR)
- Frequency and Severity of Behavioral and Psychological Symptoms of Dementia (BPSD) [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Frequency and Severity of BPSD will be measured using the Neuropsychiatric Inventory (NPI)
- Sleep Timing [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Sleep onset and offset timing data will be collected using the ActLumus, a wearable device.
- Mood Status [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Mood statu will be measured using the Dementia Mood Picture Test.
- Sleep Duration [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Sleep duration will be measured using the ActLumus, a wearable device.
- Sleep Quality [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Sleep quality will be measured using the ActLumus, a wearable device.
- Sleep stability of rest-activity rhythms [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Sleep stability of rest-activity rhythms will be measured using the ActLumus, a wearable device.
- Occurrence of Adverse Effects [Week 1:Baseline Week 3:During intervention/control Week 5:Immediately post intervention/control Week 7:2 weeks post intervention/control Week 9:During control/intervention Week 11:During control/intervention Week 13:Immediately post control/intervention]: Occurrence of adverse effects related to lights will be evaluated using a checklist, which include deteriorated behavioral and psychological symptoms of dementia (BPSD), skin rash, eye irritation, dizziness, nausea, other reactions.
+Eligibility
Sex: All, ages: 55 Years to any
Inclusion Criteria:
* Age≥55
* English speaking
* Nursing home residency≥ 4 weeks
* Clinical Diagnosis of Alzheimer's Disease and related dementia
* Presence of agitation, depression, and/or apathy.
Exclusion Criteria:
* Major mental illness
* Severe vision impairment
* Severe acute or terminal illness
+Locations (1)
| Facility | City | Country | Status |
|---|
| Pennsylvania State University | University Park, Pennsylvania | United States | |
+Funding