Sweat Sensor Device for Cystic Fibrosis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Medical conditions interfering measurements, others

No Placebo Group

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.

Trial 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 (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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Penn State Milton S. Hershey Medical Center Hershey, PA

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center Lead Sponsor

References

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

Early determination of cystic fibrosis by electrochemical chloride quantification in sweat. [2015] A novel and rapid approach to quantify chloride concentration in sweat for early detection of cystic fibrosis (CF) is shown in this work. Disposable screen-printed sensor (SPS) devices capable to induce sweat and measure the chloride concentration are presented. Pilocarpine, which was forced into de skin by means of iontophoresis, has been used to stimulate the sweat glands. Chloride concentration has been directly measured on the skin by potentiometry. The performance of the devices has been tested in synthetic samples, obtaining good agreement with the Nernst equation. Sensors reproducibility has been analyzed in terms of residual standard deviation (RSD), obtaining a value of 8% (n=6 and alpha=0.05). Finally, the application of these sensors in several volunteers has been carried out. The results were compared with the method generally used in hospitals, obtaining deviations minor than 8%.

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

Soft, skin-interfaced sweat stickers for cystic fibrosis diagnosis and management. [2023] The concentration of chloride in sweat remains the most robust biomarker for confirmatory diagnosis of cystic fibrosis (CF), a common life-shortening genetic disorder. Early diagnosis via quantitative assessment of sweat chloride allows prompt initiation of care and is critically important to extend life expectancy and improve quality of life. The collection and analysis of sweat using conventional wrist-strapped devices and iontophoresis can be cumbersome, particularly for infants with fragile skin, who often have insufficient sweat production. Here, we introduce a soft, epidermal microfluidic device ("sweat sticker") designed for the simple and rapid collection and analysis of sweat. Intimate, conformal coupling with the skin supports nearly perfect efficiency in sweat collection without leakage. Real-time image analysis of chloride reagents allows for quantitative assessment of chloride concentrations using a smartphone camera, without requiring extraction of sweat or external analysis. Clinical validation studies involving patients with CF and healthy subjects, across a spectrum of age groups, support clinical equivalence compared to existing device platforms in terms of accuracy and demonstrate meaningful reductions in rates of leakage. The wearable microfluidic technologies and smartphone-based analytics reported here establish the foundation for diagnosis of CF outside of clinical settings.

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

Soft, Skin-Integrated Multifunctional Microfluidic Systems for Accurate Colorimetric Analysis of Sweat Biomarkers and Temperature. [2020] Real-time measurements of the total loss of sweat, the rate of sweating, the temperature of sweat, and the concentrations of electrolytes and metabolites in sweat can provide important insights into human physiology. Conventional methods use manual collection processes (e.g., absorbent pads) to determine sweat loss and lab-based instrumentation to analyze its chemical composition. Although such schemes can yield accurate data, they cannot be used outside of laboratories or clinics. Recently reported wearable electrochemical devices for sweat sensing bypass these limitations, but they typically involve on-board electronics, electrodes, and/or batteries for measurement, signal processing, and wireless transmission, without direct means for measuring sweat loss or capturing and storing small volumes of sweat. Alternative approaches exploit soft, skin-integrated microfluidic systems for collection and colorimetric chemical techniques for analysis. Here, we present the most advanced platforms of this type, in which optimized chemistries, microfluidic designs, and device layouts enable accurate assessments not only of total loss of sweat and sweat rate but also of quantitatively accurate values of the pH and temperature of sweat, and of the concentrations of chloride, glucose, and lactate across physiologically relevant ranges. Color calibration markings integrated into a graphics overlayer allow precise readout by digital image analysis, applicable in various lighting conditions. Field studies conducted on healthy volunteers demonstrate the full capabilities in measuring sweat loss/rate and analyzing multiple sweat biomarkers and temperature, with performance that quantitatively matches that of conventional lab-based measurement systems.

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] Flexible biosensors for monitoring systems have emerged as a promising portable diagnostics platform due to their potential for in situ point-of-care (POC) analytic devices. Assessment of biological analytes in sweat can provide essential information for human physiology. Conventional measurements rely on laboratory equipment. This work exploits an alternative approach for epidermal sweat sensing and detection through a wearable microfluidic thread/fabric-based analytical device (μTFAD). This μTFAD is a flexible and skin-mounted band that integrates hydrophilic dot-patterns with a hydrophobic surface via embroidering thread into fabric. After chromogenic reaction treatment, the thread-embroidered patterns serve as the detection zones for sweat transferred by the hydrophilic threads, enabling precise analysis of local sweat loss, pH and concentrations of chloride and glucose in sweat. Colorimetric reference markers embroidered surrounding the working dots provide accurate data readout either by apparent color comparison or by digital acquirement through smartphone-assisted calibration plots. On-body tests were conducted on five healthy volunteers. Detection results of pH, chloride and glucose in sweat from the volunteers were 5.0-6.0, 25-80 mM and 50-200 μM by apparent color comparison with reference markers through direct visual observation. Similar results of 5.47-6.30, 50-77 mM and 47-66 μM for pH, chloride and glucose were obtained through calibration plots based on the RGB values from the smartphone app Lanse®. The limit of detection (LOD) is 10 mM for chloride concentration, 4.0-9.0 for pH and 10 μM for glucose concentration, respectively. For local sweat loss, it is found that the forehead is the region of heavy sweat loss. Sweat secretion is a cumulating process with a lower sweat rate at the beginning which increases as body movement continues along with increased heat production. These results demonstrate the capability and availability of our sensing device for quantitative detection of multiple biomarkers in sweat, suggesting the great potential for development of feasible non-invasive biosensors, with a similar performance to conventional measurements.

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

State of Sweat: Emerging Wearable Systems for Real-Time, Noninvasive Sweat Sensing and Analytics. [2022] Skin-interfaced wearable systems with integrated colorimetric assays, microfluidic channels, and electrochemical sensors offer powerful capabilities for noninvasive, real-time sweat analysis. This Perspective details recent progress in the development and translation of novel wearable sensors for personalized assessment of sweat dynamics and biomarkers, with precise sampling and real-time analysis. Sensor accuracy, system ruggedness, and large-scale deployment in remote environments represent key opportunity areas, enabling broad deployment in the context of field studies, clinical trials, and recent commercialization. On-body measurements in these contexts show good agreement compared to conventional laboratory-based sweat analysis approaches. These device demonstrations highlight the utility of biochemical sensing platforms for personalized assessment of performance, wellness, and health across a broad range of applications.

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] Analysis of sweat chloride levels in cystic fibrosis (CF) patients is essential not only for diagnosis but also for the monitoring of therapeutic responses to new drugs, such as cystic fibrosis transmembrane conductance regulator (CFTR) modulators and potentiators. Using iontophoresis as the gold standard can cause complications like burns, is uncomfortable, and requires repetitive hospital visits, which can be particularly problematic during a pandemic, where distancing and hygiene requirements are increased; therefore, it is necessary to develop fast and simple measures for the diagnosis and monitoring of CF. A screen-printed, low-cost chloride sensor was developed to remotely monitor CF patients. Using potentiometric measurements, the performance of the sensor was tested. It showed good sensitivity and a detection limit of 2.7 × 10-5 mol/L, which covered more than the complete concentration range of interest for CF diagnosis. Due to its fast response of 30 s, it competes well with standard sensor systems. It also offers significantly reduced costs and can be used as a portable device. The analysis of real sweat samples from healthy subjects, as well as CF patients, demonstrates a proper distinction using the screen-printed sensor. This approach presents an attractive remote measurement alternative for fast, simple, and low-cost CF diagnosis and monitoring.

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] Wearable sweat sensors rely either on electronics for electrochemical detection or on colorimetry for visual readout. Non-ideal form factors represent disadvantages of the former, while semiquantitative operation and narrow scope of measurable biomarkers characterize the latter. Here, we introduce a battery-free, wireless electronic sensing platform inspired by biofuel cells that integrates chronometric microfluidic platforms with embedded colorimetric assays. The resulting sensors combine advantages of electronic and microfluidic functionality in a platform that is significantly lighter, cheaper, and smaller than alternatives. A demonstration device simultaneously monitors sweat rate/loss, pH, lactate, glucose, and chloride. Systematic studies of the electronics, microfluidics, and integration schemes establish the key design considerations and performance attributes. Two-day human trials that compare concentrations of glucose and lactate in sweat and blood suggest a potential basis for noninvasive, semi-quantitative tracking of physiological status.

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

Sweat test for cystic fibrosis: Wearable sweat sensor vs. standard laboratory test. [2019] Sweat chloride testing for diagnosis of cystic fibrosis (CF) involves sweat induction, collection and handling, and measurement in an analytical lab. We have developed a wearable sensor with an integrated salt bridge for real-time measurement of sweat chloride concentration. Here, in a proof-of-concept study, we compare the performance of the sensor to current clinical practice in CF patients and healthy subjects.