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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Sweat Analysis

Intervention / Treatment
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* Other: Gx sweat patch
* Other: Reference sweat patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-40 years of age Subject is participating in training/competition with the NBA G-league Subject is participating in a coach led practice Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Each subject serves as their own control. Both devices are worn during the same exercise session.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Validation. Gx sweat collection patch<br>Left ventral forearm placement using Epicore Biosystems Gx patch | Other: Gx sweat patch<br>* Adhesive-backed flexible epidermal wearable regional sweat patch to collect and analyze sweat via microfluidics and colorimetric assay<br>|
| Other: Validation. Reference sweat collection patch<br>Right ventral forearm placement using a well-established methodology as published in peer-reviewed journals | Other: Reference sweat patch<br>* Adhesive Tegaderm with absorbent pad regional sweat patch to collect sweat, followed by standard benchtop gravimetry and ion chromatography methods to analyze sweat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional sweating rate | Gx patch vs. reference patch during exercise. Gx patch analyzed by microfluidic reading with Smartphone. Reference patch analyzed with gravimetry | Average across the same single practice session on the same 1 day as the primary outcome | 
| Whole body sweating rate | 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 | Measured one time to represent the average across the same single practice session on the same 1 day as the primary outcome | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sweating rate, sweat electrolytes, sweat electrolyte concentration, sweat patch, wearable, epidermal, Gx patch