An interventional study of Smart Environmental Light (SmartEnLite) in Alzheimer's Disease and Related Dementias and Alzheimer Disease and Related Dementias, sponsored by Penn State University. Not yet recruiting at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Penn State University · Not applicable, Interventional, and Treatment
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:
Participants will:
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's planned enrollment of 300 is above the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Penn State University is the lead sponsor of 269 studies on the registry; 52 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: Smart Environmental Light (SmartEnLite)
The SmartEnLite is designed to automatically provide bright light during the daytime and dim light at night, aiming to support circadian rhythms.
Also known as: Control: Usual light
Agitation level
Agitation level will be measured using Cohen-Mansfield Agitation Inventory.
Time frame: 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
Depression level will be measured using the Cornell Scale for Depression in Dementia (CSDD)
Time frame: 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
Apathy level will be measured using the Person-Environment Apathy Rating (PEAR)
Time frame: 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 Behavioral and Psychological Symptoms of Dementia (BPSD)
Frequency and Severity of BPSD will be measured using the Neuropsychiatric Inventory (NPI)
Time frame: 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 Timing
Sleep onset and offset timing data will be collected using the ActLumus, a wearable device.
Time frame: 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 Status
Mood statu will be measured using the Dementia Mood Picture Test.
Time frame: 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
Sleep duration will be measured using the ActLumus, a wearable device.
Time frame: 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
Sleep quality will be measured using the ActLumus, a wearable device.
Time frame: 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
Sleep stability of rest-activity rhythms will be measured using the ActLumus, a wearable device.
Time frame: 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
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.
Time frame: 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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Feb 2031, 50 months later.
Of 806 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 50 months is above that.
Counting every sponsor, half of 874 studies reached it within 31 months; a quarter within 15 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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