Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT05831800
Status:
UNKNOWN
Last Update Posted:
2023-06-18
First Post:
2023-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm prospective feasibility study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean use time of the wearable sensor', 'timeFrame': 'Up to 7 days'}], 'secondaryOutcomes': [{'measure': 'The mean number of days the sensor provides valid measurements', 'timeFrame': 'Up to 7 days'}, {'measure': 'Mean and standard deviation of the device output variables', 'timeFrame': 'Up to 7 days'}, {'measure': 'Stability of device measurements following weekly patch replacement', 'timeFrame': 'Day 8, 15, 22, 29', 'description': 'Test-retest reliability of the investigational device will be investigated by assessing the correlation between impedance measurements (in Ohm) before and after device replacement.'}, {'measure': 'Clinical assessment of hydration status', 'timeFrame': 'Day 1, 8, 15, 22, 29'}, {'measure': 'User satisfaction', 'timeFrame': 'Day 8, 15, 22, 29', 'description': 'Will be assessed using a likert scale from 1-5, where 1 represents "strongly disagree" and 5 represents "strongly agree".'}, {'measure': 'Frequency and severity of adverse device effects', 'timeFrame': 'Day 1-30'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dehydration']}, 'descriptionModule': {'briefSummary': 'This is a single-arm prospective study, investigating the feasibility, usability, and safety of a wearable bioimpedance sensor in elderly individuals. The sensor is applied on the upper back of the subject, and will be replaced once weekly. The study will include four phases, each interspersed by an interim analysis. Each phase will have a duration of four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years\n\nExclusion Criteria:\n\n* Known allergies or skin sensitivities to electrode hydrogel and/or acrylic-based adhesives\n* Non-intact skin such as skin breakdown where the device is to be placed (upper back)\n* Implantable pulse generators such as pacemakers and defibrillators\n* Any medical or psychiatric condition, which in the opinion of the investigator precludes participation'}, 'identificationModule': {'nctId': 'NCT05831800', 'acronym': 'HELD', 'briefTitle': 'Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mode Sensors AS'}, 'officialTitle': 'Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals - A Prospective Feasibility Study', 'orgStudyIdInfo': {'id': 'CTR0061A HELD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Wearable bioimpedance sensor', 'interventionNames': ['Device: Wearable bioimpedance sensor']}], 'interventions': [{'name': 'Wearable bioimpedance sensor', 'type': 'DEVICE', 'description': 'The investigational device is an electronic bioimpedance-based, body-worn, battery-powered sensor intended to monitor changes in fluid balance. It is designed as an adhesive patch with four integrated electrodes. The outer electrodes are used to supply a low current, while the inner electrodes are used for voltage measurements.', 'armGroupLabels': ['Wearable bioimpedance sensor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Remi N Birkenfeldt, MD', 'role': 'CONTACT'}, {'name': 'Remi N Birkenfeldt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tempe Helse- og velferdssenter', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'centralContacts': [{'name': 'Sigve N Aas, PhD', 'role': 'CONTACT', 'email': 'sigve.aas@modesensors.com', 'phone': '004741499074'}, {'name': 'Frida Bremnes, M.Sc.', 'role': 'CONTACT', 'email': 'frida.bremnes@modesensors.com'}], 'overallOfficials': [{'name': 'Sigve N Aas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mode Sensors AS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mode Sensors AS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}