Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-06 @ 9:45 PM
Study NCT ID:
NCT04350268
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2020-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adult Social Interaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-12', 'studyFirstSubmitDate': '2020-03-30', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech detection', 'timeFrame': '2 years', 'description': 'Talk time will be measured using computer algorithm made by the researchers in this study comparing signal to controlled, labeled signals with measured talk time.'}, {'measure': 'Administration UCLA Loneliness scale.', 'timeFrame': '2 years', 'description': 'Administration UCLA Loneliness scale as a proxyu assessment to measure socialization. https://fetzer.org/sites/default/files/images/stories/pdf/selfmeasures/Self\\_Measures\\_for\\_Loneliness\\_and\\_Interpersonal\\_Problems\\_UCLA\\_LONELINESS.pdf'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adults']}, 'descriptionModule': {'briefSummary': 'This study will collect vocalization data from healthy adults during regular daily activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy normal adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old\n* Subjects willing and able to comply with requirements of the protocol\n* Healthy\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Subjects unwilling and able to comply with requirements of the protocol\n* History of skin allergy to medical adhesive tape\n* Non-English speaking subjects'}, 'identificationModule': {'nctId': 'NCT04350268', 'briefTitle': 'Adult Social Interaction', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Exploratory Study of Wireless, Wearable Sensors at Assessing Social Interaction in Healthy Adults', 'orgStudyIdInfo': {'id': 'STU00209682'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Wearable sensor', 'type': 'DEVICE', 'otherNames': ['advanced, bio-integrated wireless sensor'], 'description': 'Wireless sensor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine, Department of Dermatology', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shuai (Steve) Xu', 'investigatorAffiliation': 'Northwestern University'}}}}