Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT05397951

Conditions

Healthy

Health Behavior

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Multi-modality Noninvasive Biosensor

Oximeter

Portable Blood Pressure Monitor

Vicorder Pulse Wave Velocity Monitor

Study Details

Brief summary:

The purpose of this study is to investigate the safe wearability and basic functions of the multi-modality sensors fabricated in the PI lab.

Conditions

Healthy

Health Behavior

Study ID

NCT05397951

Start date

Jan 9, 2024

Status verified date

Apr, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Wearing Biosensor Before & After Exercise

Each study participant will wear the bioelectronic sensors during a slow deep breath. Participants will wear the sensors and devices for 15 minutes before and after a brisk 6-minute walk.

experimental: Wearing Biosensor for an Extended Period

Each study participant will wear the bioelectronic sensors during a slow deep breath. Participants will wear the sensors and devices continuously for 2 hours.

Interventions

Multi-modality Noninvasive Biosensor

The wearable sensor devices will be placed on the finger, wrist, temple, subclavian, arm, neck, and thigh of the participant and will provide continuous tissue mechanics, heart rate, respiration rate, blood flow, and pulse oxygenation measurements continuously throughout the experimental period.

Oximeter

The oximeter device will be placed on the right middle finger of the participant and will provide continuous pulse oxygenation and heart rate measurements continuously throughout the experimental period.

Portable Blood Pressure Monitor

The blood pressure monitor device will be placed on the left arm of the participant and will take a blood pressure measurement every 5 minutes throughout the 15 minute experimental period, and every 15 minutes throughout the 2 hour experimental period.

Vicorder Pulse Wave Velocity Monitor

The pulse wave velocity monitor device will be placed on the right side of the neck and the right thigh and will provide measurements continuously throughout the experimental period.

Primary outcome measure

  • Mean Comfort Level of Wearable Sensors [ Time Frame: Questionnaire completed within 96 hours after device application. ]
  • Mean Safety Level of Wearable Sensors [ Time Frame: Questionnaire completed within 96 hours after device application. ]
  • Mean Agreement Over Time of Physiological Parameters between Newly-Fabricated Wearable Sensors and Approved Devices [ Time Frame: Through study completion, an average of 15 minutes. ]

Central Contacts and Locations

Central contacts

Hannah L Weisbecker, BS

6786417484hannahlw@alumni.unc.edu

Wubin Bai, PhD

9198439334wbai@unc.edu

Locations

Kenan Laboratories at the University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Hannah L Weisbecker, BS

678-641-7484hannahlw@alumni.unc.edu

Principal Investigator:

Wubin Bai, PhD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • sensor
  • non-invasive
  • multi-modality
  • vital signs
  • safe wearability
  • optoelectronic system
  • optical polarimetry
  • near-infrared spectroscopy
  • skin-interfaced
  • wearable

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-04-17.