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Bright Light Therapy for Individuals With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800850
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : June 17, 2016
Sponsor:
Collaborators:
Commonwealth Care of Roanoke, Inc.
Virginia Center on Aging (ARDRAF)
Information provided by (Responsible Party):
Lisa L. Onega, Radford University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Bright Light Behavioral: Placebo Light Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bright Light Therapy for Individuals With Dementia
Study Start Date : July 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bright Light Group
Bright Light Exposure
 Behavioral: Bright Light
Placebo Comparator: Control Group
Placebo Light Exposure
 Behavioral: Placebo Light


Outcome Measures
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Primary Outcome Measures :
  1. Depressive Symptom Assessment for Older Adults [ Time Frame: After the eight-week experiment ]
  2. Cohen-Mansfield Agitation Inventory (Frequency) [ Time Frame: After the eight-week experiment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800850


Sponsors and Collaborators
Radford University
Commonwealth Care of Roanoke, Inc.
Virginia Center on Aging (ARDRAF)
Investigators
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Principal Investigator: Lisa L Onega, PhD, RN, MBA Radford University
More Information
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Publications of Results:

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Responsible Party: Lisa L. Onega, Professor of Nursing, Radford University
ClinicalTrials.gov Identifier: NCT02800850    
Other Study ID Numbers: RadfordU
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lisa L. Onega, Radford University:
Dementia
Depression
Agitation
Bright Light
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders