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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02800850
Other study ID # RadfordU
Secondary ID
Status Completed
Phase N/A
First received May 31, 2016
Last updated June 16, 2016
Start date July 2013
Est. completion date July 2014

Study information

Verified date June 2016
Source Radford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Many older adults with dementia living in long-term care facilities experience depression and agitation, which cause angst and personal suffering. Prior to this research, evidence was inconclusive but indicated that bright light exposure may reduce depression and agitation in long-term care residents with dementia. The purpose of this study was to determine if the degree of improvement in depression and agitation scores over the course of eight weeks was significantly greater in persons with dementia receiving bright light exposure than in persons with dementia receiving placebo light exposure. Sixty individuals participated in the study, with 30 in the bright light group and 30 in the low level light group.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion criteria were age 60 or older; diagnosis of dementia; ophthalmology screening indicating that the individual was able to perceive light and did not have cataracts, glaucoma, macular degeneration, or retinal problems; able to sit up and keep eyes open; and not too restless to sit for 30 minutes.

Exclusion criteria were age 59 or younger; no diagnosis of dementia; presence of cataracts, glaucoma, macular degeneration, or retinal problems; unable to sit up and keep eyes open; and too restless to sit for 30 minutes.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Bright Light

Placebo Light


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Radford University Commonwealth Care of Roanoke, Inc., Radford University Waldron Research Award, Virginia Center on Aging (ARDRAF)

References & Publications (1)

Onega LL, Pierce TW, Epperly L. Effect of Bright Light Exposure on Depression and Agitation in Older Adults with Dementia. Issues Ment Health Nurs. 2016 Jun 2:1-8. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive Symptom Assessment for Older Adults After the eight-week experiment No
Primary Cohen-Mansfield Agitation Inventory (Frequency) After the eight-week experiment No
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