NCT03483896

Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients

Completed NA Results posted Last updated 29 March 2019

What this trial tests

NA trial testing Daylight Intervention in Dementia in 83 participants. Completed in 5 June 2017.

Timeline

30 January 2017

Primary endpoint
10 May 2017

5 June 2017

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	83
Start date	30 January 2017
Primary completion	10 May 2017
Estimated completion	5 June 2017
Sites	8 locations across United States

Drugs / interventions tested

• Daylight Intervention

Conditions studied

• Dementia — all drugs for Dementia →
• Depression — all drugs for Depression →
• Behavior Disorders — all drugs for Behavior Disorders →

Sponsor

University of Southern California

Who can join

Eligibility, any sex, with Dementia or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Cornell Scale for Depression in Dementia (CSDD) Primary · A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.

The Cornell Scale for Depression in Dementia (CSDD) was used to measure depression. The CSDD is designed for the assessment of depression in older people with dementia who can at least communicate basic needs. The CSDD scale ranges from 0 to 38, with higher scores indicating higher levels of depression. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 are associated with absence of significant depressive symptoms.

Group	Value	95% CI
Control	1.5	± 1.0
Daylight Intervention	-2.0	± 0.9

Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Secondary · A NPI-NH score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.

The Neuropsychiatric Inventory Nursing Home Version (NPI-NH) was used to measure neuropsychiatric symptomatology. The NPI-NH is a scale designed for assessment of people with dementia residing in extended care facilities. The NPI-NH includes ten behavioral areas (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior) and two types of neurovegetative changes (sleep and nighttime behavior disorders, appetite and eating disorders). Each of the 12 areas is scored on a subs

Group	Value	95% CI
Control	3.1	± 3.2
Daylight Intervention	-2.8	± 2.9

Sponsor's own description

This study is designed to test the hypothesis that an intervention increasing exposure to daylight indoors will reduce depression and other neuropsychiatric symptoms among people living with dementia in long term care facilities.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pilot study to examine the effects of indoor daylight exposure on depression and other neuropsychiatric symptoms in people living with dementia in long-term care communities.
   Konis K, Mack WJ, Schneider EL. · · 2018 · cited 17× · PMID 29881263 · DOI 10.2147/cia.s165224