Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-30 @ 7:32 PM
Study NCT ID:
NCT05129358
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2021-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing of an Electronic Patch During Mild Dehydration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005440', 'term': 'Fluid Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-labeled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in impedance following mild dehydration', 'timeFrame': '2 hours', 'description': 'Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days'}], 'secondaryOutcomes': [{'measure': 'Change in impedance following rehydration', 'timeFrame': '1 hour', 'description': 'Relative change in extracellular resistance measured by the investigational device following ingestion of 1500 ml Resorb (Nestlé)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dehydration', 'Rehydration'], 'conditions': ['Dehydration']}, 'referencesModule': {'references': [{'pmid': '39630397', 'type': 'DERIVED', 'citation': 'Noddeland H, Bremnes F, Thorud A, Rolid K, Kvaerness J, Jaatun EA, Aas SN. A novel wearable bioimpedance sensor for continuous monitoring of fluid balance: a study on isotonic hypovolemia in healthy adults. J Clin Monit Comput. 2025 Apr;39(2):379-391. doi: 10.1007/s10877-024-01245-z. Epub 2024 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. In addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The study will also provide information on the durability of the sensor.', 'detailedDescription': 'The subjects will use the patches for ten days. During the ten-day period, subjects are exposed to an intervention on day 2 or 3 while being monitored by health personnel:\n\n* Subjects are given a diuretic (Furosemide) and monitored for two hours without any intake.\n* The intervention is followed by intake of a rehydration solution (up to 1500 ml), containing glucose and electrolytes (Resorb Sport, Nestle S.A.).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI: 18-30\n* Age: 18-60\n* Willing to refrain from exercise for the duration of the study\n* Willing to refrain from bathing, swimming and other physical activity causing considerable sweating/movement (e.g. cycling, mountain hiking, climbing)\n\nExclusion Criteria:\n\n* Hypersensitivity to diuretics\n* Diarrhea\n* Hypotension or orthostatic hypotension\n* Urinary retention\n* Pregnancy or breast feeding\n* Allergy to medical adhesive or gel\n* Any planned medical examination during the intervention period\n* Pacemaker\n* Use of medication with a significant impact on the body's fluid balance, such as diuretic"}, 'identificationModule': {'nctId': 'NCT05129358', 'briefTitle': 'Testing of an Electronic Patch During Mild Dehydration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mode Sensors AS'}, 'officialTitle': 'Testing of an Electronic Patch During Dehydration in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CTR041 REO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydration sensor', 'description': 'The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3.', 'interventionNames': ['Drug: Dehydration', 'Dietary Supplement: Rehydration']}], 'interventions': [{'name': 'Dehydration', 'type': 'DRUG', 'otherNames': ['Dehydration from Furosemide'], 'description': 'The subject is brought to mild dehydration (loss of approximately 1.5% of body weight) through intravenous injection of up to 40 ug Furosemide. The subject shall not ingest any fluid for the next 120 minutes.', 'armGroupLabels': ['Hydration sensor']}, {'name': 'Rehydration', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Rehydration by Resorb Sport'], 'description': 'The subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake.', 'armGroupLabels': ['Hydration sensor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Sigve N Aas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mode Sensors AS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing planned. Application to ethical board does not include permission to share.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mode Sensors AS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}