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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

Tracking Information
First Submitted Date  ICMJE May 31, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date June 17, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • Depressive Symptom Assessment for Older Adults [ Time Frame: After the eight-week experiment ]
  • Cohen-Mansfield Agitation Inventory (Frequency) [ Time Frame: After the eight-week experiment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bright Light Therapy for Individuals With Dementia
Official Title  ICMJE Bright Light Therapy for Individuals With Dementia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dementia
Intervention  ICMJE
  • Behavioral: Bright Light
  • Behavioral: Placebo Light
Study Arms  ICMJE
  • Experimental: Bright Light Group
    Bright Light Exposure
    Intervention: Behavioral: Bright Light
  • Placebo Comparator: Control Group
    Placebo Light Exposure
    Intervention: Behavioral: Placebo Light
Publications * 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 Sep;37(9):660-667. doi: 10.1080/01612840.2016.1183736. Epub 2016 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2016)		 71
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800850
Other Study ID Numbers  ICMJE RadfordU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lisa L. Onega, Radford University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Radford University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Commonwealth Care of Roanoke, Inc.
  • Virginia Center on Aging (ARDRAF)
Investigators  ICMJE
Principal Investigator: Lisa L Onega, PhD, RN, MBA Radford University
PRS Account Radford University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP