A Study Of Phototherapy In Patients With Dementia To Improve BPSD

NCT07488195 | Not Yet Recruiting

• 1 other identifier: 25-005038
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia

Keywords

Use of phototherapy in patients with complex dementia

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  Day 5

Secondary Outcomes (1)

• Sleep duration

  Day 5

Study Arms (2)

Phototherapy

EXPERIMENTAL

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

Other: Phototherapy

Standard of Care

NO INTERVENTION

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

Interventions

Phototherapy OTHER

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.

Phototherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Dementia

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Stephanie P. Chambers, APRN, CNS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Gentry, MD

CONTACT

507-284-2933; gentry.melanie@mayo.edu

Donna Lawson

CONTACT

507-255-7975; lawson.donna@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)