Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-07 @ 1:49 PM
Study NCT ID:
NCT03636360
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021081', 'term': 'Chronobiology Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014467', 'term': 'Ultraviolet Therapy'}], 'ancestors': [{'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be aware that the lighting conditions will vary during their visits, but will not be aware of the nature of the difference in the lights.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alertness', 'timeFrame': '15 hours', 'description': 'Change in median reaction time score on the auditory psychomotor vigilance test'}, {'measure': 'Melatonin suppression', 'timeFrame': '3 hours', 'description': 'Amount of reduction in the concentration of salivary melatonin concentrations during an experimental light stimulus'}], 'secondaryOutcomes': [{'measure': 'Mood', 'timeFrame': '15 hours', 'description': 'Change in total positive and negative affect scores on the Positive and Negative Affect Schedule (PANAS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep', 'Circadian Dysregulation', 'Mood']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine, in healthy controls, whether LED lighting that has a color spectrum similar to that of sunlight is able to differentially impact mood, circadian rhythms, sleep, and behavior, as compared to standard fluorescent lighting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good self-reported health\n* Normal color vision\n\nExclusion Criteria:\n\n* No sleep disorders\n* No extreme chronotype\n* Regular smoker\n* Significant hearing loss\n* Depression\n* Alcohol use disorder\n* Use of illegal drugs\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT03636360', 'briefTitle': 'The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms', 'organization': {'class': 'FED', 'fullName': 'VA Palo Alto Health Care System'}, 'officialTitle': 'The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms', 'orgStudyIdInfo': {'id': 'Sunlike'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LED - Sunlike', 'description': 'LED lighting with spectral pattern similar to that of sunlight', 'interventionNames': ['Device: Light']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluorescent', 'description': 'Fluorescent light at same illuminance (lux) as LED light', 'interventionNames': ['Device: Light']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dim', 'description': 'Dim fluorescent light with same spectrum as "Fluorescent" condition', 'interventionNames': ['Device: Light']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LED', 'description': 'Standard LED lighting', 'interventionNames': ['Device: Light']}], 'interventions': [{'name': 'Light', 'type': 'DEVICE', 'description': '15 hours of light exposure', 'armGroupLabels': ['Dim', 'Fluorescent', 'LED', 'LED - Sunlike']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Palo Alto Health Care System', 'class': 'FED'}, 'collaborators': [{'name': 'Seoul Semiconductor', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jamie M. Zeitzer, Ph.D.', 'investigatorAffiliation': 'VA Palo Alto Health Care System'}}}}