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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartEnLite: A Smart Environmental Lighting Intervention to Improve Behaviors and Sleep for Nursing Home Residents Living With Dementia
- ClinicalTrials.gov ID
- NCT07883291
- Acronym / sponsor ID
- SmartEnLite / STUDY00029328
- Keywords
- Dementia, Alzheimer's disease and related dementias
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Environmental Lighting (SmartEnLite) | Experimental | Device: Smart Environmental Light (SmartEnLite) |
| Usual Light | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Major mental illness
- Severe vision impairment
- Severe acute or terminal illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Environmental Light (SmartEnLite)Also: Control: Usual lightThe SmartEnLite is designed to automatically provide bright light during the daytime and dim light at night, aiming to support circadian rhythms. | Device | Smart Environmental Lighting (SmartEnLite) |
Primary outcome
Agitation level
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
Agitation level will be measured using Cohen-Mansfield Agitation Inventory.
Depression level
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 will be measured using the Cornell Scale for Depression in Dementia (CSDD)
Apathy level
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 will be measured using the Person-Environment Apathy Rating (PEAR)
Frequency and Severity of Behavioral and Psychological Symptoms of Dementia (BPSD)
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 BPSD will be measured using the Neuropsychiatric Inventory (NPI)
Sleep Timing
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 onset and offset timing data will be collected using the ActLumus, a wearable device.
Mood Status
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 statu will be measured using the Dementia Mood Picture Test.
Sleep Duration
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 will be measured using the ActLumus, a wearable device.
Sleep Quality
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 will be measured using the ActLumus, a wearable device.
Sleep stability of rest-activity rhythms
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 will be measured using the ActLumus, a wearable device.
Occurrence of Adverse Effects
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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying-Ling Jao, PhD (814-865-5634, yuj15@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation level (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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.