Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT02598258
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2015-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D029002', 'term': 'Steam Bath'}], 'ancestors': [{'id': 'D001452', 'term': 'Balneology'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2015-10-08', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Difference between baseline and 11 minutes of intervention.'}], 'secondaryOutcomes': [{'measure': 'Arrhytmias', 'timeFrame': 'Number of arrhytmias during all 25 minutes of the intervention.', 'description': 'Patients will use a HOLTER during all experiment. Total time: 25 minutes.'}, {'measure': 'Blood pressure', 'timeFrame': 'Measured at 10 minutes after the end of the intervention (recovery period).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sauna', 'Cold water bath'], 'conditions': ['Blood Pressure', 'Arrhythmias']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety on sauna followed by cold water bath, a common practice in many countries, 30 healthy subjects aged 40 years and older will be at the Montreal Heart Institute Prevention and Cardiac Rehabilitation centre.', 'detailedDescription': 'To determine the safety on sauna followed by cold water bath, a common practice in many countries, 30 healthy subjects aged 40 years and older will be at the Montreal Heart Institute Prevention and Cardiac Rehabilitation centre. A recent complete evaluation will have excluded any cardiac condition. Subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius. Immediately after , subjects will be immersed in a cold water bath (ICool , Australia) at a temperature of 5 degrees celtius for approximately one minute. Blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath.\n\nPrincipal goal of study: to determine the safety of this practice. Secondary goals of study: to measure the blood pressure response, heart rate, presence of arrythmyas, cardiac output and cerebral perfusion during both conditions.\n\nPrimary endpoint: Change in systolic blood pressure from sauna (after 10 minutes ) to cold water (after one minute).\n\nPhysiologic measurements: continuous ECG monitoring, BP measurements at every 3 minutes during sauna and at one minute in the cold bath, gaz exchange with a portable equipment (Cosmed K4), bioimpedance and cerebral perfusion with a single frontal NIRS electrode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women and men aged 40 and older with a recent complete medical evaluation including a normal resting ECG and a normal symptom-limited treadmill exercise test.\n\nExclusion Criteria:\n\n* Any cardiac condition, abnormal exercise test, hypertension, type I diabetes and presence of any medications that may affect blood pressure.'}, 'identificationModule': {'nctId': 'NCT02598258', 'briefTitle': 'Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects', 'orgStudyIdInfo': {'id': '15-1807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sauna + Cold Water Bath', 'description': 'Subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius. Immediately after , subjects will be immersed in a cold water bath (ICool , Australia) at a temperature of 5 degrees celtius for approximately one minute. Blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath.', 'interventionNames': ['Other: Sauna and cold water bath']}], 'interventions': [{'name': 'Sauna and cold water bath', 'type': 'OTHER', 'description': 'Subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius. Immediately after, subjects will be immersed in a cold water bath (ICool , Australia) at a temperature of 5 degrees celtius for approximately one minute. Blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath.', 'armGroupLabels': ['Sauna + Cold Water Bath']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Cardiovascular Prevention and Rehabilitation Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Martin Juneau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EPIC Centrer - Montreal Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal Heart Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professeur agrégé de clinique', 'investigatorFullName': 'Mathieu Gayda', 'investigatorAffiliation': 'Montreal Heart Institute'}}}}