CClinicalTrials.gg
Not yet recruitingNCT07488195Updated Jul 16, 2026

A Study Of Phototherapy In Patients With Dementia To Improve BPSD

An interventional study of Phototherapy in Dementia, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dementia

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Keywords

  • Phototherapy
  • Complex dementia
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.

This study's planned enrollment of 70 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Phototherapy

    Patients in the phototherapy arm will receive bright light therapy for 60 minutes, 3 times per day for 5 days.

    Other: Phototherapy

  • No intervention
    Standard of Care

    Patients in the standard of care group will not receive an intervention.

Interventions

  • OtherPhototherapy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 5

  2. 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

    Time frame: Day 5

  3. 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.

    Time frame: Day 5

Secondary outcomes

  1. Sleep duration

    Sleep duration will be reported by nursing staff in hours.

    Time frame: Day 5

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    • Melanie Gentry, MD · Contact · 507-284-2933
    • Donna Lawson · Contact · 507-255-7975
    • Stephanie P. Chambers, APRN, CNS · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07488195
Lead sponsor
Mayo Clinic
Responsible party
Stephanie Chambers (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 23, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 16, 2026

Study contacts

Melanie Gentry, MD
Contact
gentry.melanie@mayo.edu
507-284-2933
Donna Lawson
Contact
lawson.donna@mayo.edu
507-255-7975
Stephanie P. Chambers, APRN, CNS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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