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

Trial Summary

What is the purpose of this trial?

Cystic fibrosis (CF) is a multisystem autosomal recessive inherited disease affecting approximately 75,000 individuals in USA. The sweat chloride (Cl) test remains the gold standard for diagnosis of CF but still has a number of limitations. The objectives of this study are: 1)To evaluate a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels as a potential low-cost but potentially accurate test to diagnoses cystic fibrosis (CF) and 2) To evaluate measurements of sweat chloride (Cl) using this same system in comparison to the standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for assessment of the diagnosis of CF. This is a single institution study performed solely at PSH-HMC. Study participants will include 1) adults 18 years of age or older capable of providing signed and dated informed consent, 2) subjects with an established known diagnosis of cystic fibrosis (CF) or healthy volunteers, and 3) able to understand and speak English language. Exclusion criteria include: 1) any medical condition or disorder known to potentially interfere with accurate measurements of sweat chloride and 2) inability to understand and speak the English language. Cystic Fibrosis (CF) subjects will be identified from the population of eligible patients receiving medical care at Penn State Health- Milton S. Hershey Medical Center (PSH-HMC). Healthy donor volunteers will be recruited from various members of the PSH-HMC CF clinical care team, members of the Division of Allergy, Pulmonary and Critical Care (both faculty and trainees) at PSH-HMC, and PSU-University Park research team. The total projected number of combined enrolled subjects is 30. This is a single day single time study that will require approximately 60 minutes of subject participation. Potential risks include a) side effects from pilocarpine iontophoresis sweat test collection (pain, skin discomfort, blisters, rarely burns and b) loss of confidentiality. There will be no cost to subjects for study participation. There will be no reimbursement financially for study participation. There is no benefit to subjects for study participation. There is the potential benefit to medical science via identification of improved method to accurately measure sweat chloride for diagnosis of CF.

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 data supports the effectiveness of the Sweat Sensor Device for Cystic Fibrosis treatment?

The Sweat Sensor Device is effective in accurately measuring chloride levels in sweat, which is crucial for diagnosing cystic fibrosis. Studies show it performs as well as traditional methods but is easier to use, especially for infants, and can be used outside of clinical settings. ^{1 2 3 4 5}

Is the Sweat Sensor Device safe for use in humans?

The Sweat Sensor Device has been tested on healthy volunteers and patients with cystic fibrosis, showing it can safely and effectively measure sweat biomarkers without causing harm. It offers a non-invasive, comfortable alternative to traditional methods, which can be cumbersome and uncomfortable. ^{2 3 4 6 7}

How does the Sweat Sensor Device treatment for cystic fibrosis differ from other treatments?

The Sweat Sensor Device is unique because it is a wearable, skin-interfaced device that allows for real-time, non-invasive monitoring of sweat chloride levels using a smartphone camera, eliminating the need for traditional lab-based sweat tests and making it more convenient and comfortable for patients, especially infants. ^{1 2 3 6 8}

Eligibility Criteria

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.

Inclusion Criteria

You are an adult over 18, have a diagnosis of cystic fibrosis or are healthy, and can speak English.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Early determination of cystic fibrosis by electrochemical chloride quantification in sweat. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Soft, skin-interfaced sweat stickers for cystic fibrosis diagnosis and management. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Soft, Skin-Integrated Multifunctional Microfluidic Systems for Accurate Colorimetric Analysis of Sweat Biomarkers and Temperature. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A thread/fabric-based band as a flexible and wearable microfluidic device for sweat sensing and monitoring. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

State of Sweat: Emerging Wearable Systems for Real-Time, Noninvasive Sweat Sensing and Analytics. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Screen-Printed Sensor for Low-Cost Chloride Analysis in Sweat for Rapid Diagnosis and Monitoring of Cystic Fibrosis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Battery-free, skin-interfaced microfluidic/electronic systems for simultaneous electrochemical, colorimetric, and volumetric analysis of sweat. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Sweat test for cystic fibrosis: Wearable sweat sensor vs. standard laboratory test. [2019]