NCT04679532

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2021

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

December 9, 2020

Last Update Submit

June 22, 2022

Conditions

Keywords

sweating ratesweat electrolytessweat electrolyte concentrationsweat patchwearableepidermalGx patch

Outcome Measures

Primary Outcomes (1)

  • Regional sweat chloride concentration

    Gx patch vs. reference patch during exercise. Gx patch analyzed by colorimetry via smartphone app. Reference patch analyzed with ion chromatography

    Average across a single practice session on 1 day

Secondary Outcomes (2)

  • Regional sweating rate

    Average across the same single practice session on the same 1 day as the primary outcome

  • Whole body sweating rate

    Measured one time to represent the average across the same single practice session on the same 1 day as the primary outcome

Study Arms (2)

Validation. Gx sweat collection patch

OTHER

Left ventral forearm placement using Epicore Biosystems Gx patch

Other: Gx sweat patch

Validation. Reference sweat collection patch

OTHER

Right ventral forearm placement using a well-established methodology as published in peer-reviewed journals

Other: Reference sweat patch

Interventions

Adhesive-backed flexible epidermal wearable regional sweat patch to collect and analyze sweat via microfluidics and colorimetric assay

Validation. Gx sweat collection patch

Adhesive Tegaderm with absorbent pad regional sweat patch to collect sweat, followed by standard benchtop gravimetry and ion chromatography methods to analyze sweat

Validation. Reference sweat collection patch

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsNo females in NBA G-League
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Subject is participating in training/competition with the NBA G-league
  • Subject is participating in a coach led practice

You may not qualify if:

  • Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages)
  • Subject has participated in a clinical trial within past 30 days
  • Subject has participated in any PepsiCo trial within past 6 months
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NBA G League Ignite Team Site Ultimate Fieldhouse, 2675 Mitchell Dr.

Walnut Creek, California, 94598, United States

Location

Study Officials

  • Lindsay B Baker, PhD

    PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) Barrington, IL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Each subject serves as their own control. Both devices are worn during the same exercise session.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 22, 2020

Study Start

December 8, 2020

Primary Completion

November 4, 2021

Study Completion

November 4, 2021

Last Updated

June 23, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations