Status:
COMPLETED
Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of Color
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Oxygen Saturation
Eligibility:
All Genders
18-65 years
Brief Summary
Purpose: Investigate the safe wearability and basic functionality - epidermal melanin concentration and blood oxygen estimation - of our developed device: Melanin-Adjusted Blood Oxygen Sensor (MABOS) ...
Eligibility Criteria
Inclusion
- Male and females, with age between 18-65
- Health individuals (defined as: not known to suffer any significant illnesses relevant to the proposed study, cited from The Textbook of Pharmaceutical Medicine)
- The investigators aim to enroll 4 participants with skin tones associated with those of African descent, 4 of East Asian Descent, and 4 of European Descent. Additionally, the investigators aim to ensure half of the group is male, the other half female.
Exclusion
- 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
- Subjects who are physically or cognitively unable to perform activities of daily living, assessed at the discretion of the investigator to ensure safe completion of study tasks.
- Inability to perform the breathing tests - deep inhalation for 10 seconds, followed by a slow exhalation no longer than 30 seconds.
- Presence of tattoos on fingers, hands, or forearms.
Key Trial Info
Start Date :
September 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05995613
Start Date
September 6 2023
End Date
February 1 2024
Last Update
March 11 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514