Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-03-29 @ 9:45 PM
Study NCT ID:
NCT02691832
Status:
UNKNOWN
Last Update Posted:
2016-02-25
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Core Body Temperature Using a Novel Non-invasive Sensor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2016-02-22', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Double sensor temperature', 'timeFrame': '3 days for each participant', 'description': 'the Double Sensor will be attached to the forehead by sticker or integrated into a helmet. Double sensor temperature will be monitored continuously.'}, {'measure': 'rectal temperature', 'timeFrame': '3 days for each participant', 'description': 'rectal thermistor is the "gold standard" for core body temperature and will be measured continuously.'}], 'secondaryOutcomes': [{'measure': 'heart rate', 'timeFrame': '4 days for each participant', 'description': 'heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).'}, {'measure': 'skin temperature', 'timeFrame': '3 days for each participant', 'description': 'The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Body Temperature Regulation']}, 'descriptionModule': {'briefSummary': 'The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.', 'detailedDescription': '12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-40 years.\n* Healthy civilian volunteers.\n* Without known medical illness or medication use.\n\nExclusion Criteria:\n\n* History of heat injury.\n* The existence or suspicion of existing cardiac or respiratory disease.\n* Diabetes.\n* Obesity.\n* Infectious disease 3 days prior to the experiment.'}, 'identificationModule': {'nctId': 'NCT02691832', 'acronym': 'Dräger', 'briefTitle': 'Measuring Core Body Temperature Using a Novel Non-invasive Sensor', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Measuring Core Body Temperature Using a Novel Non-invasive Sensor - a Follow up Study', 'orgStudyIdInfo': {'id': 'SHEBA-16-2920-HS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'research arm', 'description': 'the trial contains one group which will undergo the described protocol three times:\n\n1. connected to rectal thermistor and to the double sensor\n2. connected to rectal thermistor, double sensor and cooling system of Icetron Technologies Ltd.\n3. connected to rectal thermistor and to the double sensor integrated into a helmet.', 'interventionNames': ['Device: "Dräger" double sensor']}], 'interventions': [{'name': '"Dräger" double sensor', 'type': 'DEVICE', 'description': 'The "Dräger" Double Sensor is a novel non-invasive device for assessing core body temperature.', 'armGroupLabels': ['research arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'state': 'Ramat- Gan', 'country': 'Israel', 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Haggai Schermann, M.D', 'role': 'CONTACT', 'email': 'Haggai.Schermann@sheba.health.gov.il', 'phone': '+972828771014'}], 'overallOfficials': [{'name': 'Haggai Schermann, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}