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Not yet recruiting NCT07488195

A Study Of Phototherapy In Patients With Dementia To Improve BPSD

No phase Interventional Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phototherapy.
Who it may be relevant to
Registry conditions: Dementia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility of 5-day phototherapy protocol [Time frame: Day 5]
  • Acceptability of 5-day phototherapy protocol [Time frame: Day 5]
  • Tolerability of 5-day phototherapy protocol [Time frame: Day 5]
Secondary outcome measures (1)
  • Sleep duration [Time frame: Day 5]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07488195 · 25-005038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗