Healthy AdultsNCT03566381
Sweat Sensors for Athletic Performance
An observational study of Healthy Adults, run by Northwestern University at 1 site in United States.
Trial summary
Pilot study of a soft, flexible wearable sweat sensor Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Application of a soft patch composed of medical-grade silicone that collects sweat during a subject's natural behaviors.
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to 9 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- No history of medical or surgical problems
- Age >18 years old
- Subjects willing and able to comply with requirements of the protocol
Who cannot join
- Age <18 years old
- Subjects unwilling and able to comply with requirements of the protocol
- History of skin allergy to medical adhesive tape
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of a Wearable Sweat Sensor for Hydration Monitoring of Athletes
Pilot study of a soft, flexible wearable sweat sensor
Read the detailed description
Assessment of safety, and preliminary accuracy of a sweat sensor capable of operating underwater.
- Conditions
- Healthy Adults
- Being tested
- Application of a soft patch composed of medical-grade silicone that collects sweat during a subject's natural behaviors.
- Keywords
- Wearable sensor, sweat sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of a soft patch composed of medical-grade silicone that collects sweat during a subject's natural behaviors.Device
This device contains sweat sensors embedded in an elastomer and is applied to the skin with a medical grade adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy adults without a history of medical or surgical problems Receives: Device: Application of a soft patch composed of medical-grade silicone that collects sweat during a subject's natural behaviors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion of device underwater
Percentage of devices which remain adhered during >1 hr swim trials
Measured: 2 hours
Secondary outcomes (1)
Correlation between local and global sweat loss
Percentage agreement of local sweat rate with body weight loss
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start15 Jul 2018
- Primary completion1 May 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
- Investigators
- Shuai Xu, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566381
- Sponsor's protocol ID
- SX01262018
- Status last verified
- Jun 2022
- First submitted
- 2 May 2018
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Wearable Sweat Sensor for Hydration Monitoring of Athletes
- ClinicalTrials.gov ID
- NCT03566381
- Acronym / sponsor ID
- SX01262018
- Conditions
- Healthy Adults
- Keywords
- Wearable sensor, sweat sensor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study of a soft, flexible wearable sweat sensor
Detailed description
Assessment of safety, and preliminary accuracy of a sweat sensor capable of operating underwater.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Device: Application of a soft patch composed of medical-grade silicone that collects sweat during a subject's natural behaviors.Healthy adults without a history of medical or surgical problems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (3 listed)
- No history of medical or surgical problems
- Age >18 years old
- Subjects willing and able to comply with requirements of the protocol
Key exclusion criteria (3 listed)
- Age <18 years old
- Subjects unwilling and able to comply with requirements of the protocol
- History of skin allergy to medical adhesive tape
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of a soft patch composed of medical-grade silicone that collects sweat during a subject's natural behaviors.This device contains sweat sensors embedded in an elastomer and is applied to the skin with a medical grade adhesive. | Device | Healthy adults |
Primary outcome
Adhesion of device underwater
Time frame: 2 hours
Percentage of devices which remain adhered during >1 hr swim trials
1 secondary outcome
Correlation between local and global sweat loss
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuai Xu principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adults, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion of device underwater (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.