Validation of wearable bioelectronic sensors
Evaluation of Wearable Multi-modality Sensors for Monitoring Vital Signs
This study tests new wearable sensors to see if they are safe and work well while people do different activities, including exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05397951 on ClinicalTrials.gov |
What this trial studies
This study investigates the safe wearability and basic functions of innovative, multi-modality wearable sensors developed in the lab. Participants will wear these sensors alongside approved medical devices to record various physiological measurements during different activities, including exercise. The aim is to validate the sensors' safety and functionality, providing preliminary data that could lead to future studies focused on specific disease models. Participants will return for follow-up visits to monitor any potential adverse events related to the devices.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18 to 99 without significant illnesses.
Not a fit: Patients with active skin disorders, allergies to adhesives, or those unable to perform moderate exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of advanced wearable devices that provide continuous, non-invasive health monitoring.
How similar studies have performed: While the approach of using wearable sensors is gaining traction, this specific validation study is novel and aims to establish foundational data for future applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals with ages between 18 and 99. * Healthy individuals (not known to suffer any significant illness relevant to the proposed study). Exclusion Criteria: * Pregnant or lactating. * History of active (clinically significant) skin disorders that make skin vulnerable to contact conventional electronic devices. * History of allergic response to silicones or adhesives (such as 3M Tegaderm). * Broken, damaged or irritated skin or rashes near the sensor application sites (finger, wrist, temple, subclavian, arm, neck, and thigh). * Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator to ensure safe completion of study tasks. * Subjects who are unable to participate in moderate exercise for 6 minutes.
Where this trial is running
Chapel Hill, North Carolina
- Kenan Laboratories at the University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Wubin Bai, PhD — Assistant Professor of Applied Physical Sciences
- Study coordinator: Hannah L Weisbecker, BS
- Email: hannahlw@alumni.unc.edu
- Phone: 6786417484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.