Alzheimer's Disease and Related DementiasSmartEnLiteNCT07883291
SmartEnLite for Nursing Home Residents With Dementia
A study testing Smart Environmental Light (SmartEnLite) in people with Alzheimer's Disease and Related Dementias and Alzheimer Disease and Related Dementias, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Disease and Related Dementias, Alzheimer Disease and Related Dementias
- What is being tested?
- Smart Environmental Light (SmartEnLite)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to Feb 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Major mental illness
- Severe vision impairment
- Severe acute or terminal illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: SmartEnLite: A Smart Environmental Lighting Intervention to Improve Behaviors and Sleep for Nursing Home Residents Living With Dementia
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.
Read more
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.
- Being tested
- Smart Environmental Light (SmartEnLite)
- Keywords
- Dementia, Alzheimer's disease and related dementias
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Environmental Light (SmartEnLite)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Smart Environmental Lighting (SmartEnLite) | Experimental | Not described Receives: Device: Smart Environmental Light (SmartEnLite) |
| Usual Light | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation level
Agitation level will be measured using Cohen-Mansfield Agitation Inventory.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease and Related DementiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ying-Ling Jao RN, PhD, FGSA, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883291
- Sponsor's protocol ID
- STUDY00029328
- Other IDs
- R01AG100732
- Acronym
- SmartEnLite
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No