Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-28 @ 10:41 AM
Study NCT ID:
NCT04679532
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2020-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each subject serves as their own control. Both devices are worn during the same exercise session.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2020-12-09', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional sweat chloride concentration', 'timeFrame': 'Average across a single practice session on 1 day', 'description': 'Gx patch vs. reference patch during exercise. Gx patch analyzed by colorimetry via smartphone app. Reference patch analyzed with ion chromatography'}], 'secondaryOutcomes': [{'measure': 'Regional sweating rate', 'timeFrame': 'Average across the same single practice session on the same 1 day as the primary outcome', 'description': 'Gx patch vs. reference patch during exercise. Gx patch analyzed by microfluidic reading with Smartphone. Reference patch analyzed with gravimetry'}, {'measure': 'Whole body sweating rate', 'timeFrame': 'Measured one time to represent the average across the same single practice session on the same 1 day as the primary outcome', 'description': 'Change in body mass from pre- to post-exercise, corrected for fluid/food intake and urine loss. Body mass measured to the nearest 0.01 kg using a digital platform scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sweating rate', 'sweat electrolytes', 'sweat electrolyte concentration', 'sweat patch', 'wearable', 'epidermal', 'Gx patch'], 'conditions': ['Sweat Analysis']}, 'descriptionModule': {'briefSummary': 'To determine the validity of the Gx Sweat Patch in measuring sweating rate and sweat chloride concentration during moderate-high intensity practice against well-established reference methods in field conditions with basketball athletes'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'No females in NBA G-League', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years of age\n* Subject is participating in training/competition with the NBA G-league\n* Subject is participating in a coach led practice\n\nExclusion Criteria:\n\n* Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages)\n* Subject has participated in a clinical trial within past 30 days\n* Subject has participated in any PepsiCo trial within past 6 months\n* Subject has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk'}, 'identificationModule': {'nctId': 'NCT04679532', 'briefTitle': 'NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players', 'orgStudyIdInfo': {'id': 'PEP-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Validation. Gx sweat collection patch', 'description': 'Left ventral forearm placement using Epicore Biosystems Gx patch', 'interventionNames': ['Other: Gx sweat patch']}, {'type': 'OTHER', 'label': 'Validation. Reference sweat collection patch', 'description': 'Right ventral forearm placement using a well-established methodology as published in peer-reviewed journals', 'interventionNames': ['Other: Reference sweat patch']}], 'interventions': [{'name': 'Gx sweat patch', 'type': 'OTHER', 'description': 'Adhesive-backed flexible epidermal wearable regional sweat patch to collect and analyze sweat via microfluidics and colorimetric assay', 'armGroupLabels': ['Validation. Gx sweat collection patch']}, {'name': 'Reference sweat patch', 'type': 'OTHER', 'description': 'Adhesive Tegaderm with absorbent pad regional sweat patch to collect sweat, followed by standard benchtop gravimetry and ion chromatography methods to analyze sweat', 'armGroupLabels': ['Validation. Reference sweat collection patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'NBA G League Ignite Team Site Ultimate Fieldhouse, 2675 Mitchell Dr.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}], 'overallOfficials': [{'name': 'Lindsay B Baker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) Barrington, IL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}