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

NCT05998629 | Recruiting

• 1 other identifier: 7772
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

Sweat Chloride Test; Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Sweat chloride concentration using standard of care lab assessment

  Sweat chloride concentration in mmol/L

  Single point in time measurement 60 minutes after device attachment

Secondary Outcomes (1)

• Sweat chloride concertation using skin-interfaced colorimetric device

  Single point in time measurement 60 minutes after device attachment

Study Arms (4)

Healthy control subjects experimental device

EXPERIMENTAL

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

Device: a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels

Healthy control subjects standard of care

ACTIVE COMPARATOR

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

Other: Standard of Care laboratory procedure for measurement of sweat

Cystic Fibrosis Subjects experimental device

EXPERIMENTAL

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

Device: a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels

Cystic Fibrosis Subjects standard of care

ACTIVE COMPARATOR

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

Other: Standard of Care laboratory procedure for measurement of sweat

Interventions

Standard of Care laboratory procedure for measurement of sweat OTHER

a skin-interface sweat measurement using a smart-watch type device

Cystic Fibrosis Subjects standard of care; Healthy control subjects standard of care

a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels DEVICE

a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels

Cystic Fibrosis Subjects experimental device; Healthy control subjects experimental device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Robert Vender

CONTACT

17175316525; rvender@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Comparison of sweat chloride measure using standard of care versus experimental device in both control and cystic fibrosis subjects

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)