Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-31 @ 6:06 PM
Study NCT ID:
NCT06998667
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-03
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cooling Solutions for Outdoor Workers
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core Temperature', 'timeFrame': 'up to 10 hours', 'description': 'Rate of core temperature change as measured by core temperature pill'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['outdoor work', 'heat stress', 'kidney injury', 'cooling interventions'], 'conditions': ['Hyperthermia', 'Heat Acclimation and Thermotolerance']}, 'descriptionModule': {'briefSummary': 'The investigators aim to test the effectiveness of two cooling interventions in reducing the core temperature of outdoor workers.', 'detailedDescription': 'Workers in a variety of US industries-construction workers, welders, farmers, firefighters, and warehouse workers among them-are at risk for hyperthermia during work, yet very few interventions are being developed to mitigate heat related organ injury, particularly when workers do not have obvious symptoms of heat related illness. The investigators plan to test whether two active cooling technologies can help mitigate hyperthermia and risk for kidney injury. This work will enhance worker safety using evidence-based technology.\n\nTo accomplish the aims of testing two active cooling interventions, the investigators plan to implement a case-cross over randomized control trial design at the work site conducted in partnership with an employer and with 30 workers at risk for hyperthermia. Over three sequential weeks, the investigators will measure rate of core temperature change (primary outcome). Secondary outcomes will include changes in kidney injury markers; changes in worker productivity; and worker acceptability of interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18\n2. Anticipated to be working in the same job category for the duration of the study\n3. Able to communicate in English or Spanish\n\nExclusion Criteria:\n\n1. Cannot provide informed consent\n2. Weight less than 40 kg\n3. Inability to swallow pills\n4. Known history of having a pacemaker or ICD\n5. Pregnancy as determined by self report and confirmed on Day 1\n6. Gastrointestinal disorders (e.g., gastroparesis, prior surgery on GI tract with the exception of appendectomy or cholecystectomy, diverticulosis or inflammatory bowel disease)\n7. Plan for an elective MRI in the 7 days post last planned pill ingestion'}, 'identificationModule': {'nctId': 'NCT06998667', 'briefTitle': 'Cooling Solutions for Outdoor Workers', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Cooling Solutions for Outdoor Workers', 'orgStudyIdInfo': {'id': '80246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Heat Illness Prevention', 'description': 'Standard CAL-OSHA workplace heat illness prevention interventions, which require availability of cool, potable water; availability of shade when temperatures exceed 80F; and encouragement of rest for cool down breaks.', 'interventionNames': ['Behavioral: Standard Heat Illness Prevention Measures']}, {'type': 'EXPERIMENTAL', 'label': 'Cooling bandana with Standard Heat Illness Prevention Measures', 'description': 'Provision of a bandana with slow-evaporation polymer for use during work, in addition to standard CAL-OSHA workplace heat illness prevention interventions', 'interventionNames': ['Behavioral: Standard Heat Illness Prevention Measures', 'Other: Cooling bandana']}, {'type': 'EXPERIMENTAL', 'label': 'Cooling glove with standard Heat Illness Prevention', 'description': 'Provision of a glove with ability to circulate cool water, for use during breaks, in addition to standard CAL-OSHA workplace heat illness prevention interventions', 'interventionNames': ['Behavioral: Standard Heat Illness Prevention Measures', 'Other: Cooling glove']}], 'interventions': [{'name': 'Standard Heat Illness Prevention Measures', 'type': 'BEHAVIORAL', 'description': 'Standard CAL-OSHA workplace heat illness prevention interventions, which require availability of cool, potable water; availability of shade when temperatures exceed 80F; and encouragement of rest for cool down breaks', 'armGroupLabels': ['Cooling bandana with Standard Heat Illness Prevention Measures', 'Cooling glove with standard Heat Illness Prevention', 'Standard Heat Illness Prevention']}, {'name': 'Cooling bandana', 'type': 'OTHER', 'description': 'Cooling bandana embedded with a polymer to slow evaporation', 'armGroupLabels': ['Cooling bandana with Standard Heat Illness Prevention Measures']}, {'name': 'Cooling glove', 'type': 'OTHER', 'description': 'Cooling glove with ability to circulate cool water interface with palmar skin', 'armGroupLabels': ['Cooling glove with standard Heat Illness Prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Shuchi Anand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Julie Parsonnet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Maria Montez Rath, mrath@stanford.edu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At the moment we plan to reserve individual participant data for current project only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Nephrology', 'investigatorFullName': 'Shuchi Anand', 'investigatorAffiliation': 'Stanford University'}}}}