Sweat Sensor Device for Cystic Fibrosis

Overseen By Robert Vender

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Medical conditions interfering measurements, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sweat sensor device to determine if it can diagnose cystic fibrosis (CF) more accurately and affordably than current methods. CF is a genetic condition affecting the lungs and other organs, and diagnosis typically involves measuring sweat chloride levels. The trial compares results from this new device against standard lab tests. Participants can be healthy volunteers or individuals with a known CF diagnosis, provided they understand and speak English. The study occurs in a single session lasting about an hour. As an unphased trial, participants contribute to advancing diagnostic technology and potentially improving future CF diagnosis methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if your medication could interfere with sweat chloride measurements, it might be a concern.

What prior data suggests that this sweat sensor device is safe for diagnosing cystic fibrosis?

Research has shown that skin-interfaced sweat sensors, like the one tested for cystic fibrosis, are generally easy to use and comfortable. These devices are designed to be affordable and simple. They lack the electrical components found in other sensors, making them gentler on the skin.

In past trials, participants using similar devices reported very few side effects. Any discomfort was usually minor, such as slight skin irritation. The main risks stem from the sweat collection process, which might cause some pain or skin discomfort, but these effects are rare and temporary.

Studies have found these devices promising for non-invasive monitoring, allowing for the checking of sweat chloride levels without breaking the skin. Overall, based on current data, these devices appear safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sweat sensor device for cystic fibrosis because it offers a new, non-invasive way to measure sweat chloride levels, which is crucial for diagnosing and monitoring this condition. Unlike standard lab procedures that require a controlled environment and specialized equipment, this skin-interfaced device is portable and user-friendly. It features a colorimetric bifluidic design with two channels, allowing for real-time, on-the-spot analysis without the need for laboratory settings. This innovation could make testing more accessible and convenient for patients, reducing the need for frequent hospital visits.

What evidence suggests that this sweat sensor device is effective for diagnosing cystic fibrosis?

This trial will compare a new skin sensor device with standard clinical laboratory procedures for measuring sweat chloride concentrations. Research has shown that this skin-interfaced colorimetric bifluidic sweat sensor device might help diagnose conditions like cystic fibrosis (CF). The device accurately measures sweat components, such as chloride levels, which are crucial for diagnosing CF. It uses a combination of electronics and tiny fluid channels to easily collect and analyze sweat. Early studies suggest that this device could offer a low-cost, reliable alternative to traditional testing methods. Although more research is needed, initial results are promising for its use in CF diagnosis. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and speak English. It's open to those with a confirmed diagnosis of cystic fibrosis or healthy volunteers. People with conditions affecting sweat chloride measurements or non-English speakers cannot join.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Single Day Study

Participants undergo sweat chloride testing using both standard clinical laboratory procedures and the experimental skin-interfaced colorimetric bifluidic sweat device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects following the sweat chloride testing

1 day

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device

Trial Overview The study tests a new skin-interfaced device that measures sweat to diagnose cystic fibrosis, comparing its accuracy against standard lab procedures at Penn State Health Milton S. Hershey Medical Center.

How Is the Trial Designed?

Group I: Healthy control subjects experimental device Experimental Treatment 1 Intervention

a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for healthy control subjects

Group II: Cystic Fibrosis Subjects experimental device Experimental Treatment 1 Intervention

a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for cystic fibrosis subjects

Group III: Cystic Fibrosis Subjects standard of care Active Control 1 Intervention

standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for measurement of sweat chloride concentrations for cystic fibrosis subjects

Group IV: Healthy control subjects standard of care Active Control 1 Intervention

standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for measurement of sweat chloride concentrations for healthy control subjects

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

Recent advancements in skin-interfaced wearable systems allow for noninvasive, real-time analysis of sweat, providing valuable insights into personal health and performance.

These wearable sensors have shown good accuracy when compared to traditional laboratory methods, making them suitable for use in field studies, clinical trials, and commercial applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of Sweat: Emerging Wearable Systems for Real-Time, Noninvasive Sweat Sensing and Analytics. Ghaffari, R., Yang, DS., Kim, J., et al.[2022]

Wearable microfluidic devices can accurately measure total sweat loss, sweat rate, and analyze sweat composition (including pH, chloride, glucose, and lactate) in real-time, providing insights into human physiology without the need for laboratory settings.

Field studies with healthy volunteers showed that these devices perform comparably to traditional lab methods, demonstrating their potential for practical applications in monitoring hydration and metabolic status during physical activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft, Skin-Integrated Multifunctional Microfluidic Systems for Accurate Colorimetric Analysis of Sweat Biomarkers and Temperature. Choi, J., Bandodkar, AJ., Reeder, JT., et al.[2020]

The wearable microfluidic thread/fabric-based analytical device (μTFAD) effectively measures sweat biomarkers such as pH, chloride, and glucose, demonstrating similar performance to traditional laboratory methods.

On-body tests with five healthy volunteers showed that the μTFAD can accurately detect sweat composition, with limits of detection for chloride, pH, and glucose being 10 mM, 4.0-9.0, and 10 μM, respectively, indicating its potential for non-invasive health monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A thread/fabric-based band as a flexible and wearable microfluidic device for sweat sensing and monitoring. Zhao, Z., Li, Q., Chen, L., et al.[2021]

A new low-cost, portable chloride sensor was developed for remote monitoring of sweat chloride levels in cystic fibrosis (CF) patients, providing a fast response time of just 30 seconds.

This sensor effectively distinguishes between healthy individuals and CF patients, offering a safer and more convenient alternative to traditional iontophoresis methods for diagnosing and monitoring CF, especially during times when hospital visits are challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screen-Printed Sensor for Low-Cost Chloride Analysis in Sweat for Rapid Diagnosis and Monitoring of Cystic Fibrosis. Hauke, A., Oertel, S., Knoke, L., et al.[2021]

The new battery-free, wireless sweat sensors combine electronic and colorimetric detection methods, making them lighter, cheaper, and smaller than existing options, while effectively monitoring multiple biomarkers like glucose and lactate.

Human trials over two days indicate that these sensors can noninvasively track physiological status by comparing sweat and blood concentrations of glucose and lactate, suggesting their potential for real-time health monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Battery-free, skin-interfaced microfluidic/electronic systems for simultaneous electrochemical, colorimetric, and volumetric analysis of sweat. Bandodkar, AJ., Gutruf, P., Choi, J., et al.[2023]

A new disposable sensor can quickly measure chloride levels in sweat, which is important for the early detection of cystic fibrosis, using pilocarpine to stimulate sweat production.

In tests with volunteers, the sensor's results closely matched traditional hospital methods, with less than 8% deviation, demonstrating its reliability and potential for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early determination of cystic fibrosis by electrochemical chloride quantification in sweat. Gonzalo-Ruiz, J., Mas, R., de Haro, C., et al.[2015]

The wearable sensor developed for measuring sweat chloride can provide real-time results within 15 minutes, requiring a smaller sweat volume than traditional methods, which is beneficial for patients.

The sensor's measurements showed a strong correlation (Pearson coefficient of 0.97) with conventional laboratory results, indicating it is a reliable alternative for diagnosing cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sweat test for cystic fibrosis: Wearable sweat sensor vs. standard laboratory test. Choi, DH., Thaxton, A., Jeong, IC., et al.[2019]

A new soft, epidermal microfluidic device, called a 'sweat sticker', allows for easy and efficient collection and analysis of sweat chloride, which is crucial for diagnosing cystic fibrosis (CF).

Clinical validation shows that this device is as accurate as traditional methods while significantly reducing leakage, making it suitable for use in various age groups, including infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft, skin-interfaced sweat stickers for cystic fibrosis diagnosis and management. Ray, TR., Ivanovic, M., Curtis, PM., et al.[2023]

Citations

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Skin-interfaced systems for sweat collection and analytics The advances in sweat collection and analytics follow from a convergence of electronics, electrochemistry, and microfluidics.

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Recent advances in skin-interfaced wearable sweat sensors Recent advances in skin-interfaced wearable sweat sensors enable the non-invasive, real-time monitoring of biochemical signals associated with health and ...