Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT02800850
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2016-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bright Light Therapy for Individuals With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive Symptom Assessment for Older Adults', 'timeFrame': 'After the eight-week experiment'}, {'measure': 'Cohen-Mansfield Agitation Inventory (Frequency)', 'timeFrame': 'After the eight-week experiment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dementia', 'Depression', 'Agitation', 'Bright Light'], 'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '27254531', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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.\n\nExclusion 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.'}, 'identificationModule': {'nctId': 'NCT02800850', 'briefTitle': 'Bright Light Therapy for Individuals With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Radford University'}, 'officialTitle': 'Bright Light Therapy for Individuals With Dementia', 'orgStudyIdInfo': {'id': 'RadfordU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bright Light Group', 'description': 'Bright Light Exposure', 'interventionNames': ['Behavioral: Bright Light']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Placebo Light Exposure', 'interventionNames': ['Behavioral: Placebo Light']}], 'interventions': [{'name': 'Bright Light', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Bright Light Group']}, {'name': 'Placebo Light', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lisa L Onega, PhD, RN, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Commonwealth Care of Roanoke, Inc.', 'class': 'UNKNOWN'}, {'name': 'Virginia Center on Aging (ARDRAF)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nursing', 'investigatorFullName': 'Lisa L. Onega', 'investigatorAffiliation': 'Radford University'}}}}