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Bright Light Therapy for Individuals With Dementia

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bright Light
Placebo Light
Sponsored by
Radford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Depression, Agitation, Bright Light

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Bright Light Group

    Control Group

    Arm Description

    Bright Light Exposure

    Placebo Light Exposure

    Outcomes

    Primary Outcome Measures

    Depressive Symptom Assessment for Older Adults
    Cohen-Mansfield Agitation Inventory (Frequency)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 31, 2016
    Last Updated
    June 16, 2016
    Sponsor
    Radford University
    Collaborators
    Commonwealth Care of Roanoke, Inc., Virginia Center on Aging (ARDRAF)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02800850
    Brief Title
    Bright Light Therapy for Individuals With Dementia
    Official Title
    Bright Light Therapy for Individuals With Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Radford University
    Collaborators
    Commonwealth Care of Roanoke, Inc., Virginia Center on Aging (ARDRAF)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia
    Keywords
    Dementia, Depression, Agitation, Bright Light

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bright Light Group
    Arm Type
    Experimental
    Arm Description
    Bright Light Exposure
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Light Exposure
    Intervention Type
    Behavioral
    Intervention Name(s)
    Bright Light
    Intervention Type
    Behavioral
    Intervention Name(s)
    Placebo Light
    Primary Outcome Measure Information:
    Title
    Depressive Symptom Assessment for Older Adults
    Time Frame
    After the eight-week experiment
    Title
    Cohen-Mansfield Agitation Inventory (Frequency)
    Time Frame
    After the eight-week experiment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa L Onega, PhD, RN, MBA
    Organizational Affiliation
    Radford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27254531
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Bright Light Therapy for Individuals With Dementia

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