Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT01350505
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2011-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia
Sponsor:
Organization:
Raw JSON
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To determine goodness of balance while walking, the variability in stride length (i.e., variance in stride-to-stride length) was calculated in each of the conditions. Increased variability in stride length is associated with increased risk of falling.', 'unitOfMeasure': '%CV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy older adults. Note 4 participants declined to participate in the last condition (white room light).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Light Exposure', 'description': '13 minutes of experimental light exposure during the night'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Light Exposure', 'description': '13 minutes of experimental light exposure during the night'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'spread': '6.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline total sleep time', 'classes': [{'categories': [{'measurements': [{'value': '7.32', 'spread': '.73', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline sleep efficiency', 'classes': [{'categories': [{'measurements': [{'value': '91.9', 'spread': '5.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of time in bed person is asleep', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Balance Self-Efficacy Scale', 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'spread': '3.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '0-100, with higher scores being better balance', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mini Mental State Examination', 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'spread': '0.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '0-30, with higher scores being better overall cognition', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pittsburgh Sleep Quality Index', 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '0-21, with higher scores being worse sleep and scores \\>5 associated with clinically significant sleep problems', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Geriatric Depression Scale', 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '0-15, with higher scores representing greater depressive symptoms; scores \\>5 are suggestive of depression and \\>10 are almost always depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alcohol Use Disorders Identification Test', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '0-40, higher scores representing greater risk for alcohol use disorder\n\nscore: 0-7, Alcohol education score 8-15, Simple advice score 16-19, Simple advice plus brief counseling and continued monitoring score 20-40, Referral to specialist for diagnostic evaluation and treatment', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-26', 'size': 480929, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-26T14:46', 'hasProtocol': True}, {'date': '2018-09-26', 'size': 473339, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-26T14:48', 'hasProtocol': False}, {'date': '2016-08-31', 'size': 621478, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-09-26T17:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The order of the interventions were randomized to the four visits.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2011-05-06', 'resultsFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2011-05-06', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-26', 'studyFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Balance', 'timeFrame': '13 minutes', 'description': 'Balance was assessed during a 13-minute nocturnal light exposure (4 different conditions) and differences between the conditions were assessed. To determine goodness of balance while walking, the variability in stride length (i.e., variance in stride-to-stride length) was calculated in each of the conditions. Increased variability in stride length is associated with increased risk of falling.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postural Balance', 'Sleep Initiation and Maintenance Disorders'], 'conditions': ['Falls', 'Balance', 'Insomnia', 'Aging']}, 'referencesModule': {'references': [{'pmid': '27448415', 'type': 'RESULT', 'citation': 'McBean AL, Najjar RP, Schuchard RA, Hall CD, Wang CA, Ku B, Zeitzer JM. Standing Balance and Spatiotemporal Aspects of Gait Are Impaired Upon Nocturnal Awakening in Healthy Late Middle-Aged and Older Adults. J Clin Sleep Med. 2016 Nov 15;12(11):1477-1486. doi: 10.5664/jcsm.6270.'}]}, 'descriptionModule': {'briefSummary': 'To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 55-85\n* Stable health\n* Normal color vision\n\nExclusion Criteria:\n\n* Alcohol abuse\n* Depression\n* Sleep disorders\n* Smoking\n* Use of illegal drugs'}, 'identificationModule': {'nctId': 'NCT01350505', 'briefTitle': 'Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia', 'orgStudyIdInfo': {'id': 'E0773-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects', 'description': '13 minutes of light at night (2 hours after bedtime)', 'interventionNames': ['Behavioral: White light exposure', 'Behavioral: Dim white light exposure', 'Behavioral: Very dim white light exposure', 'Behavioral: Dim orange light exposure']}], 'interventions': [{'name': 'White light exposure', 'type': 'BEHAVIORAL', 'description': '\\~200 lux of broad spectrum white light', 'armGroupLabels': ['All subjects']}, {'name': 'Dim white light exposure', 'type': 'BEHAVIORAL', 'description': '\\~28 lux of broad spectrum white light', 'armGroupLabels': ['All subjects']}, {'name': 'Very dim white light exposure', 'type': 'BEHAVIORAL', 'description': '\\<0.5 lux of broad spectrum white light', 'armGroupLabels': ['All subjects']}, {'name': 'Dim orange light exposure', 'type': 'BEHAVIORAL', 'description': '\\~28 lux of orange light', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304-1290', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System, Palo Alto, CA', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Jamie M Zeitzer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'All relevant summary data is presented in a publication under review. Anonymized, individual participant data would be made available upon request and completion of necessary documentation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}