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Skin-Interfaced Sweat Sensor for Cystic Fibrosis Diagnosis

This study is testing a new device called a skin-interfaced colorimetric bifluidic sweat device. This device aims to be a simple and accurate way to diagnose cystic fibrosis (CF) by measuring sweat chloride (Cl) levels. Researchers will compare the results from this new device to the standard lab test for sweat chloride. The goal is to see if the new device can overcome some of the challenges of current testing, like needing enough sweat or being difficult for young children. You might be able to join if you are an adult aged 18 to 80, have a known diagnosis of CF or are a healthy volunteer, and can speak English. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 30 participants. It compares a new skin-interfaced colorimetric bifluidic sweat device to the standard lab procedure for measuring sweat.
What's involved
You would have a skin-interfaced colorimetric bifluidic sweat device attached for 60 minutes, and also have a standard sweat measurement using a smart-watch type device.
Compensation
Not stated in the trial record.
Follow-up
Sweat chloride concentration is measured at a single point in time, 60 minutes after device attachment.

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NCT05998629

Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device for the Diagnosis of Cystic Fibrosis (CF)

Recruiting
NAAges 18–80InterventionalDiagnostic
Milton S. Hershey Medical Center
~30 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:a skin-interfaced colorimetric bifluidic sweat device with two synchronous channelsStandard of Care laboratory procedure for measurement of sweat

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sweat chloride concentration using standard of care lab assessment
Measured over Single point in time measurement 60 minutes after device attachment

Conditions

Cystic Fibrosis

Explore related trials

Cystic Fibrosis

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Robert Vender
[email protected]
17175316525
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Eligibility criteria

Inclusion

adults 18 years of age or older capable of providing signed and dated informed consent,
subjects with an established known diagnosis of cystic fibrosis (CF) or healthy volunteers,
able to understand and speak English language.

Exclusion

any medical condition or disorder known to potentially interfere with accurate measurements of sweat chloride
inability to understand and speak the English language.

What this trial measures

  • Sweat chloride concentration using standard of care lab assessmentSingle point in time measurement 60 minutes after device attachment

    Sweat chloride concentration in mmol/L