Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 1:24 AM
Study NCT ID:
NCT06584903
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Indoor Temperature Limit for Fans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-03', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes', 'description': 'Measured with an electrocardiogram-gated automated cuff'}, {'measure': 'Rate Pressure Product', 'timeFrame': 'At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes'}, {'measure': 'Heart Rate', 'timeFrame': 'At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial', 'description': 'Measured with a 3-lead electrocardiogram'}, {'measure': 'Skin Temperature', 'timeFrame': 'At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial', 'description': 'Measured at 4 skin locations (chest, arm, thigh, and calf) using wireless iButtons affixed to the skin with surgical tape'}, {'measure': 'Core Temperature', 'timeFrame': 'At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial', 'description': 'rectal temperature measured with a pediatric grade thermistor probe'}, {'measure': 'Whole-Body Sweat Rate', 'timeFrame': 'At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial', 'description': 'Net difference in body mass (pre versus post) using a balance scale placed below the chair of the participant'}], 'secondaryOutcomes': [{'measure': 'Thermal Sensation', 'timeFrame': 'At baseline (e.g. 0 minutes), and every 10 minutes for the 180 minute experimental trial', 'description': 'visual analog scale'}, {'measure': 'Thermal comfort', 'timeFrame': 'Assessed at baseline (e.g. 0 minutes), and every 10 minutes for the 180 minute experimental trial', 'description': 'visual analog scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['indoor temperature', 'core temperature', 'heart rate', 'electric fans', 'cardiovascular strain'], 'conditions': ['Heat Exposure', 'Healthy', 'Young Adults', 'Fans']}, 'descriptionModule': {'briefSummary': 'Extreme heat events are a significant global threat to health and wellbeing, and result in more morbidity and mortality than all other natural disasters combined. Thus, a key priority is identifying effective and accessible heat resilience solutions to protect individuals from the potentially fatal consequences of heat stress. Within a range of ambient conditions, a fan has been recognized a low-cost heat resilience solution. However, when ambient temperatures exceed skin temperatures (e.g., above 35°C), a fan will incur greater dry heat gain which may be counterbalanced with evaporation of sweat from the skin surface. However, at a critical indoor temperature, the rate of heat gain will exceed the rate of evaporation resulting in net heat gain. The critical indoor temperature has yet to be determined. The purpose of this present study is to identify the indoor temperature at which a fan results in greater cardiovascular and thermal strain relative to still air in young adults using a simulated heat wave scenario of a warming room.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index less than 30\n* male or female\n* ability to tolerate hot environments for a prolonged period (e.g. \\>2 h)\n\nExclusion Criteria:\n\n* Any respiratory disease\n* Any cardiovascular disease, including hypertension\n* Diabetes\n* not currently on any medication (except oral contraceptives)'}, 'identificationModule': {'nctId': 'NCT06584903', 'briefTitle': 'Safe Indoor Temperature Limit for Fans', 'organization': {'class': 'OTHER', 'fullName': 'Lakehead University'}, 'officialTitle': 'Fan Use During Extreme Heat: Safe Thermal Limits', 'orgStudyIdInfo': {'id': '26897'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Still air', 'description': 'still air condition with no supplemental air flow', 'interventionNames': ['Other: Temperature Ramp Protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Electric fan', 'description': 'Force air flow with a 46 cm 3-blade fan positioned 1.2 m anterior to the participants chest', 'interventionNames': ['Other: Temperature Ramp Protocol']}], 'interventions': [{'name': 'Temperature Ramp Protocol', 'type': 'OTHER', 'description': 'Following a 45 minute baseline in 37°C seated on a chair, the indoor temperature in the climate-controlled room increased from 37°C to 47°C at \\~0.06°C/min (relative humidity \\~26%) over 180 minutes.', 'armGroupLabels': ['Electric fan', 'Still air']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P7B 5E1', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lakehead University', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}], 'overallOfficials': [{'name': 'Nicholas Ravanelli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Singapore'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Following publication', 'ipdSharing': 'YES', 'description': 'All deidentified participant data supporting the findings of this study will be made freely available on the Open Science Framework Repository.', 'accessCriteria': 'Anyone will be allowed to access the data supporting the findings through the Open Science Framework Repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lakehead University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nicholas Ravanelli', 'investigatorAffiliation': 'Lakehead University'}}}}