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A Study Of Phototherapy In Patients With Dementia To Improve BPSD

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07488195
Enrollment
70
Registered
2026-03-23
Start date
2026-08-15
Completion date
2026-12-31
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Phototherapy, Complex dementia

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.

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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of 5-day phototherapy protocolDay 5Feasibility will be defined as the percentage of eligible patients who choose to enroll in the study out of total patients approached.
Acceptability of 5-day phototherapy protocolDay 5Accessibility will be defined as the percentage of study participants to complete at least one session per day of the 5-day protocol
Tolerability of 5-day phototherapy protocolDay 5Tolerability 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

MeasureTime frameDescription
Sleep durationDay 5Sleep duration will be reported by nursing staff in hours.

Countries

United States

Contacts

CONTACTMelanie Gentry, MD
gentry.melanie@mayo.edu507-284-2933
CONTACTDonna Lawson
lawson.donna@mayo.edu507-255-7975
PRINCIPAL_INVESTIGATORStephanie P. Chambers, APRN, CNS

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026