Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-25 @ 4:47 PM
Study NCT ID:
NCT02560103
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2015-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Investigate the Effects of Rapid Transmeridian Travel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-22', 'studyFirstSubmitDate': '2015-09-21', 'studyFirstSubmitQcDate': '2015-09-23', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG)', 'timeFrame': '4 days'}, {'measure': 'Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel.', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Jet Lag Disorder']}, 'descriptionModule': {'briefSummary': 'Observational study to investigate circadian rhythm patterns'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability and acceptance to provide written consent\n* Men or women between 18-75 years\n* Body Mass Index of ≥ 18 and ≤ 30 kg/m2\n\nExclusion Criteria:\n\n* History (within the 12 months prior to screening) of psychiatric disorders\n* Major surgery, trauma, illness or immobile for 3 or more days within the past month\n* Pregnancy or recent pregnancy (within 6 weeks)\n* A positive test for drugs of abuse at the screening visit\n* Any other sound medical reason as determined by the clinical investigator'}, 'identificationModule': {'nctId': 'NCT02560103', 'briefTitle': 'An Observational Study to Investigate the Effects of Rapid Transmeridian Travel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'An Observational Study to Investigate the Effects of Rapid Travel', 'orgStudyIdInfo': {'id': 'VP-VEC-162-0101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single group', 'description': 'No treatment', 'interventionNames': ['Other: Transmeridian travel across multiple time zones']}], 'interventions': [{'name': 'Transmeridian travel across multiple time zones', 'type': 'OTHER', 'armGroupLabels': ['Single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Santa Monica Clinical Trials', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center for Sleep & Wake Disorders', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}