- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03566381
Sweat Sensors for Athletic Performance
June 8, 2022 updated by: Shuai (Steve) Xu, Northwestern University
Pilot Study of a Wearable Sweat Sensor for Hydration Monitoring of Athletes
Pilot study of a soft, flexible wearable sweat sensor
Study Overview
Status
Completed
Conditions
Detailed Description
Assessment of safety, and preliminary accuracy of a sweat sensor capable of operating underwater.
Study Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy adults
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy adults
Healthy adults without a history of medical or surgical problems
|
This device contains sweat sensors embedded in an elastomer and is applied to the skin with a medical grade adhesive.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adhesion of device underwater
Time Frame: 2 hours
|
Percentage of devices which remain adhered during >1 hr swim trials
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between local and global sweat loss
Time Frame: 2 hours
|
Percentage agreement of local sweat rate with body weight loss
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 15, 2018
Primary Completion (ACTUAL)
May 1, 2021
Study Completion (ACTUAL)
August 9, 2021
Study Registration Dates
First Submitted
May 2, 2018
First Submitted That Met QC Criteria
June 20, 2018
First Posted (ACTUAL)
June 25, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SX01262018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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