DementiaNCT07488195
A Study Of Phototherapy In Patients With Dementia To Improve BPSD
A study testing Phototherapy in people with Dementia, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to determine whether the use of phototherapy can help reduce behavioral and psychological symptoms, including agitation in people with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Phototherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2026to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted on the inpatient Domitilla 3D or 4D unit.
- Documented diagnosis of dementia or suspected major neurocognitive disorder.
- Presence of BPSD symptoms either clinician documented in EHR or assessed through CMAI-O form
- Have patient consent or have a LAR able to sign the consent on behalf of the patient.
Who cannot join
- Macular degeneration, blindness, or photosensitivity
- Patients that do not have capacity to consent and do not have a legally authorized representative to consent on their behalf
- Recent eye surgery
- Bipolar disorder
- Pregnancy
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Melanie Gentry, MD, 507-284-2933
Donna Lawson, 507-255-7975
About this study
Official title: Implementation Of Phototherapy In Patients With Dementia To Improve BPSD: A Pilot Study
The purpose of this research is to determine whether the use of phototherapy can help reduce behavioral and psychological symptoms, including agitation in people with dementia.
- Conditions
- Dementia
- Being tested
- Phototherapy
- Keywords
- Phototherapy, Complex dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyOther
Bright light therapy will be provided via the Verilux HappyLight. The unit will be placed on a mobile bedside table, at eye level, 60 cm from the patient. Patients will receive phototherapy in 60 minute sessions, 3 times daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy | Experimental | Patients in the phototherapy arm will receive bright light therapy for 60 minutes, 3 times per day for 5 days. Receives: Other: Phototherapy |
| Standard of Care | No intervention | Patients in the standard of care group will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of 5-day phototherapy protocol
Feasibility will be defined as the percentage of eligible patients who choose to enroll in the study out of total patients approached.
Measured: Day 5
Acceptability of 5-day phototherapy protocol
Accessibility will be defined as the percentage of study participants to complete at least one session per day of the 5-day protocol
Measured: Day 5
Tolerability of 5-day phototherapy protocol
Tolerability will be defined as percentage of patients to rate phototherapy as 'very tolerable' based on being asked "Considering all aspects of your experience, how would you rate the overall tolerability of the phototherapy?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable.
Measured: Day 5
Secondary outcomes (1)
Sleep duration
Sleep duration will be reported by nursing staff in hours.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start20 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Chambers, Mayo Clinic
- Investigators
- Stephanie P. Chambers, APRN, CNS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488195
- Sponsor's protocol ID
- 25-005038
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Of Phototherapy In Patients With Dementia To Improve BPSD: A Pilot Study
- ClinicalTrials.gov ID
- NCT07488195
- Acronym / sponsor ID
- 25-005038
- Conditions
- Dementia
- Keywords
- Phototherapy, Complex dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Mar 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 purpose of this research is to determine whether the use of phototherapy can help reduce behavioral and psychological symptoms, including agitation in people with dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phototherapy | Experimental | Other: PhototherapyPatients in the phototherapy arm will receive bright light therapy for 60 minutes, 3 times per day for 5 days. |
| Standard of Care | No intervention | –Patients in the standard of care group will not receive an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients admitted on the inpatient Domitilla 3D or 4D unit.
- Documented diagnosis of dementia or suspected major neurocognitive disorder.
- Presence of BPSD symptoms either clinician documented in EHR or assessed through CMAI-O form
- Have patient consent or have a LAR able to sign the consent on behalf of the patient.
Key exclusion criteria (5 listed)
- Macular degeneration, blindness, or photosensitivity
- Patients that do not have capacity to consent and do not have a legally authorized representative to consent on their behalf
- Recent eye surgery
- Bipolar disorder
- Pregnancy
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 |
|---|---|---|
| PhototherapyBright light therapy will be provided via the Verilux HappyLight. The unit will be placed on a mobile bedside table, at eye level, 60 cm from the patient. Patients will receive phototherapy in 60 minute sessions, 3 times daily for 5 days. | Other | Phototherapy |
Primary outcome
Feasibility of 5-day phototherapy protocol
Time frame: Day 5
Feasibility will be defined as the percentage of eligible patients who choose to enroll in the study out of total patients approached.
Acceptability of 5-day phototherapy protocol
Time frame: Day 5
Accessibility will be defined as the percentage of study participants to complete at least one session per day of the 5-day protocol
Tolerability of 5-day phototherapy protocol
Time frame: Day 5
Tolerability will be defined as percentage of patients to rate phototherapy as 'very tolerable' based on being asked "Considering all aspects of your experience, how would you rate the overall tolerability of the phototherapy?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable.
1 secondary outcome
Sleep duration
Time frame: Day 5
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 26 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Stephanie P. Chambers, APRN, CNS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy in people with Dementia, run by Mayo Clinic 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 4 inclusion and 5 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 26 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 Melanie Gentry, MD (507-284-2933, gentry.melanie@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of 5-day phototherapy protocol (time frame: Day 5). The study lists 3 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 26 Oct 2026.