Sweat Sensor Device for Cystic Fibrosis
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?
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.23467
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.12368
Research Team
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
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Single Day Study
Participants undergo sweat chloride testing using both standard clinical laboratory procedures and the experimental skin-interfaced colorimetric bifluidic sweat device
Follow-up
Participants are monitored for any adverse effects following the sweat chloride testing
Treatment Details
Interventions
- Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device (Device)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor