Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-01 @ 5:40 PM
Study NCT ID:
NCT04251234
Status:
TERMINATED
Last Update Posted:
2021-08-12
First Post:
2020-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light at Night Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D020795', 'term': 'Photophobia'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'There is no masking. The dim light (\\<1 lux) condition is first, followed by the room light (\\~30 lux) condition. Participants are aware of this condition order.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'COVID shutdown', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Melatonin levels', 'timeFrame': 'Up to approximately 6 weeks', 'description': 'Melatonin will be reported as an average percentage of suppression in the \\~30 lux condition as compared to \\<1 lux'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circadian', 'Light Intensity'], 'conditions': ['Bipolar Disorder', 'Light Sensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression I, and compare it to healthy controls. This is not a treatment study.', 'detailedDescription': 'The bipolar disorder I and healthy control arms are recruited from the existing Heinz C. Prechter Bipolar Research Program at the University of Michigan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18-30 kg/m2\n* Appropriate sleep schedules according to study staff. Sleep schedule is self-reported and confirmed through a sleep diary\n* Healthy eyes as ascertained by eye exam at University of Michigan Kellogg Eye Center\n* Willing and able to maintain stable sleep schedule during study.\n* Participants will be breathalyzed and undergo urine drugs screens at every lab visit\n* Acknowledge and understand that participants cannot drive themselves home after certain lab visits. Note that the research team will provide a travel stipend of $10 per visit to offset potential rideshare/taxi costs\n\nExclusion Criteria:\n\n* Color blindness'}, 'identificationModule': {'nctId': 'NCT04251234', 'acronym': 'LAN', 'briefTitle': 'Light at Night Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Light at Night Study', 'orgStudyIdInfo': {'id': 'HUM00173528'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy controls', 'description': '* No co-morbid medical or psychiatry diagnoses\n* No family history of mental illness\n* No current medication use\n* Non-smoking', 'interventionNames': ['Other: Light intensity, ~30 lux', 'Other: Baseline light intensity, <1 lux']}, {'type': 'EXPERIMENTAL', 'label': 'Bipolar I disorder', 'description': '* Clinical diagnosis of Bipolar I disorder\n* Can be (not required, not exclusionary) taking lithium and/or sodium valproate and/or antidepressants\n* Can be (not required, not exclusionary) light smokers', 'interventionNames': ['Other: Light intensity, ~30 lux', 'Other: Baseline light intensity, <1 lux']}], 'interventions': [{'name': 'Light intensity, ~30 lux', 'type': 'OTHER', 'description': '\\~30 lux compared to very dim light baseline condition \\<1 lux', 'armGroupLabels': ['Bipolar I disorder', 'Healthy controls']}, {'name': 'Baseline light intensity, <1 lux', 'type': 'OTHER', 'description': 'Very dim light condition', 'armGroupLabels': ['Bipolar I disorder', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Helen Burgess, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Helen Burgess', 'investigatorAffiliation': 'University of Michigan'}}}}