Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT04625634
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2020-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation of Consecutive Day Shift Work
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084462', 'term': 'Hyperthermia'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Repeated measures study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core temperature', 'timeFrame': '20 minutes', 'description': 'Gastrointestinal temperature measured with an ingestable pill.'}, {'measure': 'Heart rate', 'timeFrame': '20 minutes', 'description': 'Heart rate measured with a wearable heart rate strap and monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperthermia', 'Fatigue; Heat']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine differences in physiological recovery between two consecutive days of simulated fire suppression work. The secondary purpose is to determine differences in heat gain and heat loss between two consecutive days of simulated fire suppression work. Subjects will complete two consecutive days of simulated structural firefighting shift work, 24 hours apart. Before and after each laboratory visit, subjects will continuously wear a Holter monitor and ambulatory blood pressure monitor to quantify parasympathetic tone and recovery from work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-39 y old men and women\n* Self-reported to be healthy\n\nExclusion Criteria:\n\n* History of any cardiovascular, neurologic, renal, or metabolic disease\n* Current tobacco use or regular use within the last 2 years\n* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)\n* History of exertional heat stroke\n* Currently pregnant or breastfeeding, or planning to become pregnant during the study\n* Inability to follow the rules of the protocols or understand the consent form\n* No contraindications for ingestion of the gastrointestinal temperature pill'}, 'identificationModule': {'nctId': 'NCT04625634', 'briefTitle': 'Simulation of Consecutive Day Shift Work', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Simulation of Consecutive Day Shift Work', 'orgStudyIdInfo': {'id': 'STUDY00003948'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Consecutive work', 'description': 'Subjects will complete 2 consecutive days of simulated firefighting tasks in the heat. The simulated work consists of 20 minutes of simulated structural work in a hot environment, followed by 20 minutes of seated rest in a temperate room, mimicking a typical recovery period in structural firefighting. Subjects then re-enter the environmental chamber and complete 23 minutes of simulated overhaul work in a temperate environment.', 'interventionNames': ['Other: 2 days of work heat stress']}], 'interventions': [{'name': '2 days of work heat stress', 'type': 'OTHER', 'description': '2 consecutive days of identical simulated structural firefighting tasks.', 'armGroupLabels': ['Consecutive work']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Research and Exercise in Special Environments', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual data can be made available upon written request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Riana Pryor', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}