Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 7:12 AM
Study NCT ID:
NCT06992050
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of the Thermal Protection Provided by Submarine Rescue Suits: Half Suit Versus Full Suit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core temperature', 'timeFrame': 'two hours', 'description': 'Core temp. measured with telemetric pills'}], 'secondaryOutcomes': [{'measure': 'Subjective cold sensation -', 'timeFrame': 'two hours', 'description': 'Assessed using a standardized cold discomfort scale during immersion and raft sitting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cold Exposure, Hypothermia, Thermal Insulation, Immersion Suits, Submarine Evacuation']}, 'descriptionModule': {'briefSummary': 'This study evaluated the thermal and functional performance of full-body versus half-body Submarine Escape Immersion Equipment (SEIE) suits during cold water immersion (\\~16.5°C) and raft sitting. Twenty submariners were divided into two groups.', 'detailedDescription': 'This study investigates the performance of full-body versus half-body Submarine Escape Immersion Equipment (SEIE) suits under conditions simulating submarine emergencies in cold water (\\~16.5°C). In such scenarios, rapid evacuation and prolonged exposure to cold water pose significant risks of hypothermia and impaired physical function. The aim was to assess and compare the thermal insulation and motor performance effects of both suit designs during water immersion and raft sitting.\n\nTwenty healthy active-duty submariners (age 22 ± 1 years) participated, divided evenly into two groups (full suit vs. half suit). Core temperature was monitored using ingestible sensors, and subjective cold sensation was assessed regularly throughout immersion and raft sitting. Additional outcome measures included fine motor dexterity (assembling shackles) and handgrip strength, recorded before and after exposure.\n\nThe experimental protocol involved one session per participant. Anthropometric data were collected, and subjects underwent a controlled immersion and raft sitting protocol using calibrated thermal equipment. Motor function tasks were standardized and repeated to control for learning effects. Statistical analysis included non-parametric repeated measures tests with appropriate corrections for multiple comparisons.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of healthy, active-duty male submariners from the Israeli Navy, aged 20 to 25 years. All participants were volunteers with no prior acclimatization to cold water or cold environments. Each participant underwent a medical screening by a qualified physician to confirm eligibility and provided written informed consent prior to participation. The cohort was selected to represent operationally relevant individuals likely to utilize Submarine Escape Immersion Equipment (SEIE) suits in real-world scenarios.', 'genderDescription': 'self-representattion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy active-duty submariners\n\nMale participants aged 20-25 years\n\nNo history of cardiovascular, respiratory, or neurological disorders\n\nNot acclimatized to cold environments or cold water exposure\n\nProvided written informed consent\n\nMedically cleared for cold water immersion by a physician prior to participation -\n\nExclusion Criteria:\n\nHistory of cardiovascular, respiratory, metabolic, neurological, or musculoskeletal disorders\n\nRegular exposure to cold environments or cold water (cold-acclimatized individuals)\n\nUse of medications that could affect thermoregulation or neuromuscular function\n\nAny skin conditions that may be aggravated by cold water immersion\n\nInability to provide informed consent\n\nFailure to pass pre-exposure medical examination by a study physician\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06992050', 'briefTitle': 'Comparative Evaluation of the Thermal Protection Provided by Submarine Rescue Suits: Half Suit Versus Full Suit', 'organization': {'class': 'OTHER', 'fullName': 'Medical Corps, Israel Defense Force'}, 'officialTitle': 'Comparative Evaluation of the Thermal Protection Provided by Submarine Rescue Suits: Half Suit Versus Full Suit', 'orgStudyIdInfo': {'id': '1895 - 2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Full Suit Group', 'description': 'Participants wearing full-body Submarine Escape Immersion Equipment (SEIE) suits', 'interventionNames': ['Device: Submariner suit']}, {'label': 'Half Suit Group', 'description': 'Participants wearing half-body Submarine Escape Immersion Equipment (SEIE) suits', 'interventionNames': ['Device: Submariner suit']}], 'interventions': [{'name': 'Submariner suit', 'type': 'DEVICE', 'description': 'Participants wearing full-body Submarine Escape Immersion Equipment (SEIE) suits', 'armGroupLabels': ['Full Suit Group', 'Half Suit Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Israel Naval Medical Institute', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Oren GABAY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ISRAEL NAVAL MEDICAL INSTITUTE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The raw, de-identified data collected during the study will be made available upon reasonable request. The dataset contains no personally identifiable information and includes only aggregated physiological and performance measurements. Data will be shared for academic, scientific, or regulatory purposes following review and approval by the principal investigator. Requests can be directed to the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Corps, Israel Defense Force', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Dror Ofir', 'investigatorAffiliation': 'Medical Corps, Israel Defense Force'}}}}