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NCT Number: NCT07488195

A Study Of Phototherapy In Patients With Dementia To Improve BPSD

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location contact

Donna Lawson

CONTACT

507-255-7975

Melanie Gentry, MD

CONTACT

507-284-2933

Stephanie P. Chambers, APRN, CNS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. Sleep duration

    Time frame: Day 5

    Sleep duration will be reported by nursing staff in hours.

Study contacts

Contact information is provided by the study sponsor or research team.

Donna Lawson

CONTACT

[email protected]

507-255-7975

Melanie Gentry, MD

CONTACT

[email protected]

507-284-2933

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Implementation Of Phototherapy In Patients With Dementia To Improve BPSD: A Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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