A Study Of Phototherapy In Patients With Dementia To Improve BPSD

March 17, 2026 updated by: Stephanie Chambers, Mayo Clinic

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
        • Contact:
          • Melanie Gentry, MD
          • Phone Number: 507-284-2933
        • Contact:
          • Donna Lawson
          • Phone Number: 507-255-7975
        • Principal Investigator:
          • Stephanie P. Chambers, APRN, CNS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phototherapy
Patients in the phototherapy arm will receive bright light therapy for 60 minutes, 3 times per day for 5 days.
Other: Phototherapy
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.
No Intervention: Standard of Care
Patients in the standard of care group will not receive an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 5
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
Day 5
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.
Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep duration
Time Frame: Day 5
Sleep duration will be reported by nursing staff in hours.
Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Stephanie P. Chambers, APRN, CNS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-005038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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