Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT06310135
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2024-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Filtered Eyewear to Prevent Light-induced Melatonin Suppression - Aim 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Melatonin Levels AUC', 'timeFrame': 'Each night for 6 study nights', 'description': 'Melatonin levels to assess Melatonin Suppression. Saliva samples will be collected every 30 minutes for melatonin levels.'}], 'secondaryOutcomes': [{'measure': 'Karolinska Sleepiness scale to measure Subjective Sleepiness', 'timeFrame': 'Each night for 6 study nights', 'description': 'Subjective sleepiness will be measured using the Karolinska Sleepiness scale. This 9-point scale scores range from 1-9, where 1 = "very alert," 3 = "alert," 5 = "neither alert nor sleepy," 7 = "sleepy, but no difficulty remaining awake," and 9 = "very sleepy, fighting sleep, an effort to remain awake." Full scale from 1-9. A higher number indicates greater sleepiness.'}, {'measure': 'Numerical Verification Task (NVT)', 'timeFrame': 'Each night for 6 study nights', 'description': 'The NVT requires participants to compare 2 lists of 20 pairs of 5-digit numerals at 2 contrasts (0.2 and 0.8), and the response time required to complete the task is recorded as the performance measure. A faster response time indicates better visual performance.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Quality']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the relative effectiveness of monocular and binocular light exposures, with and without selective blue-blocking filtering, on nocturnal melatonin suppression, subjective sleepiness, and visual performance of night shift workers.', 'detailedDescription': 'Over the course of six, 5-hour study nights, 30 participants will be randomized to 6 study conditions, 1) binocular dim-light control unfiltered, (2) monocular dim-light control (one eye occluded), (3) unfiltered binocular, (4) unfiltered monocular (non-dominant eye occluded), (5) filtered binocular (both eyes filtered), (6) filtered monocular (non-dominant eye filtered, the other non-filtered). Saliva samples will be collected every 30 minutes for melatonin levels. Participants will also be asked to provide subjective sleepiness and visual performance will be assessed. Study nights will be separated by one week and each participant will be randomized to one of the six study conditions each night. All participants will see all conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n\nExclusion Criteria:\n\n* Bipolar disorder\n* Seasonal depression\n* Diabetes\n* High blood pressure\n* History of cancer\n* Obstructing cataracts\n* Macular degeneration\n* Diabetic retinopathy\n* Glaucoma\n* Use of melatonin supplements\n* Use of beta blockers\n* Use of sleep medications\n* Use of antidepressant medication'}, 'identificationModule': {'nctId': 'NCT06310135', 'briefTitle': 'Filtered Eyewear to Prevent Light-induced Melatonin Suppression - Aim 1', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Filtered Eyewear to Prevent Light-induced Melatonin Suppression While Maintaining Visual Performance and Alertness in Night-shift Working Nurses - Aim 1', 'orgStudyIdInfo': {'id': 'STUDY-23-00816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unfiltered Monocular', 'description': 'Unfiltered monocular with the non-dominant eye occluded.', 'interventionNames': ['Device: Unfiltered Eyewear']}, {'type': 'EXPERIMENTAL', 'label': 'Filtered Binocular', 'description': 'Filtered binocular with both eyes filtered.', 'interventionNames': ['Device: Filtered Eyewear']}, {'type': 'EXPERIMENTAL', 'label': 'Filtered Monocular', 'description': 'Filtered monocular with non-dominant eye filtered, the other non-filtered.', 'interventionNames': ['Device: Filtered Eyewear']}, {'type': 'EXPERIMENTAL', 'label': 'Unfiltered Binocular', 'description': 'Unfiltered binocular - neither eye will be filtered.', 'interventionNames': ['Device: Unfiltered Eyewear']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dim Light Control', 'description': 'Dim light with no filters.', 'interventionNames': ['Other: No Filters']}], 'interventions': [{'name': 'Filtered Eyewear', 'type': 'DEVICE', 'description': 'Filtered binocular viewing condition will be produced by eyeglasses frames with orange-tinted blue-blocking filter, eliminating all optical radiation for wavelengths shorter than 540 nm. For the filtered monocular condition, only the lens on the eyeglasses frame on the non-dominant eye will be tinted with the blue-blocking filter.', 'armGroupLabels': ['Filtered Binocular', 'Filtered Monocular']}, {'name': 'Unfiltered Eyewear', 'type': 'DEVICE', 'description': 'For the unfiltered binocular, the subjects will wear transparent eyeglasses frames with no optical power. Unfiltered monocular vision will be produced by an opaque eyepatch occluding the non-dominant eye.', 'armGroupLabels': ['Unfiltered Binocular', 'Unfiltered Monocular']}, {'name': 'No Filters', 'type': 'OTHER', 'description': 'Dim lights with no filters.', 'armGroupLabels': ['Dim Light Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12204', 'city': 'Menands', 'state': 'New York', 'country': 'United States', 'facility': 'Light and Health Research Center', 'geoPoint': {'lat': 42.69202, 'lon': -73.72456}}], 'overallOfficials': [{'name': 'Mariana Figueiro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'overall results will be shared, not individual results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mariana Figueiro', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}