Chicago, Illinois 60611

  • Healthy Adults

Purpose:

Pilot study of a soft, flexible wearable sweat sensor


Study summary:

Assessment of safety, and preliminary accuracy of a sweat sensor capable of operating underwater.


Criteria:

Inclusion Criteria: - No history of medical or surgical problems - Age >18 years old - Subjects willing and able to comply with requirements of the protocol Exclusion Criteria: - Age <18 years old - Subjects unwilling and able to comply with requirements of the protocol - History of skin allergy to medical adhesive tape


Study is Available At:


Original ID:

SX01262018


NCT ID:

NCT03566381


Secondary ID:


Study Acronym:


Brief Title:

Sweat Sensors for Athletic Performance


Official Title:

Pilot Study of a Wearable Sweat Sensor for Hydration Monitoring of Athletes


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Northwestern University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Shuai Xu
Principal Investigator
Northwestern University

Study Dates

Start Date:July 15, 2018
Completion Date:May 1, 2022
Completion Type:Anticipated
Primary Completion Date:May 1, 2021
Primary Completion Type:Actual
Verification Date:May 2021
Last Changed Date:May 6, 2021
First Received Date:May 2, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Correlation between local and global sweat loss
Time Frame:2 hours
Safety Issues:False
Description:Percentage agreement of local sweat rate with body weight loss
Outcome Type:Primary Outcome
Measure:Adhesion of device underwater
Time Frame:2 hours
Safety Issues:False
Description:Percentage of devices which remain adhered during >1 hr swim trials

Study Interventions

Intervention Type:Device
Name:Application of a soft patch composed of medical-gr
Description:This device contains sweat sensors embedded in an elastomer and is applied to the skin with a medical grade adhesive.
Arm Name:Healthy adults

Study Arms

Study Arm Type:Other
Arm Name:Healthy adults
Description:Healthy adults without a history of medical or surgical problems

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Northwestern University

Samples and Retentions

Study Population: Healthy adults
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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