Bright Light Therapy for Individuals With Dementia

June 16, 2016 updated by: Lisa L. Onega, Radford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bright Light Group
Bright Light Exposure
Behavioral: Bright Light
Placebo Comparator: Control Group
Placebo Light Exposure
Behavioral: Placebo Light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depressive Symptom Assessment for Older Adults
Time Frame: After the eight-week experiment
After the eight-week experiment
Cohen-Mansfield Agitation Inventory (Frequency)
Time Frame: After the eight-week experiment
After the eight-week experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radford University

Collaborators

Commonwealth Care of Roanoke, Inc.
Virginia Center on Aging (ARDRAF)

Investigators

  • Principal Investigator: Lisa L Onega, PhD, RN, MBA, Radford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Estimate)

June 17, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RadfordU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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