Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of

Status Recruiting

Clinical Trial 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) Participants: Healthy adults 18-65 years of age Procedures (methods): The investigators plan to enroll 12 healthy adult participants for the study. The investigators aim to enroll 4 participants with skin tones associated with those of African descent (Group A), 4 of East Asian descent (Group B), and 4 of European descent (Group C). Additionally, the investigators aim to ensure half of group is male, and the other half female. For the duration of the study, two wearable devices will be placed on the participant: a Nonin PureSat pulse oximeter on a forefinger, and the novel wearable pulse oximeter - MABOS - on the other forefinger. Prior to testing, an Ocean HR2 XR Spectrometer will be used to assess the absorbance of three wavelengths of light - 410, 660, 940 nm - on each patient's inner wrist. Following this, the two devices will be placed on the patient, set up, and calibrated for 10 minutes. During the calibration period, MABOS will be used to measure the same three wavelengths of light utilized by the Ocean HR2 XR Spectrometer (410, 660, and 940 nm). After the calibration period, all participants will be asked to perform the following procedure 5 times as part of the testing period: a deep inhalation lasting no longer than 10 seconds, followed by a slow exhalation lasting no longer than 30 seconds. Between each trial, a five-minute break will be required. For the entire testing period, all two devices will be continuously acquiring data. After this testing period, all two devices will continue taking measurements until 90 minutes have elapsed. Skin integrity will be examined before spectrometer use, after spectrometer use, after the calibration period, every 30 minutes after the start of the testing period, and after the testing period. During the study, if the participants report any uncomfortable feeling and/or pain or if a change to the skin at the site of device placement occurs, the measurements will be discontinued, and all the devices placed on the participants will be removed. Questionnaires will be provided after the study period and during follow-up visits approximately 48 hours and 96 hours post the device testing visit for a proof-of-concept evaluation of the safe wearability.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Oxygen Saturation

Clinical Trial Details

NCT number	NCT05995613
Study type	Observational
Source	University of North Carolina, Chapel Hill
Contact	Wubin Bai, Ph.D.
Phone	617-949-9089
Email	wbai@unc.edu
Status	Recruiting
Phase
Start date	September 6, 2023
Completion date	December 15, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Terminated	`NCT05030012` - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants	N/A
Recruiting	`NCT06101641` - Effect of Shellac Nail Polish Application on Pulse Oximetry Measurements in Healthy Individuals	N/A
Terminated	`NCT03967587` - Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients	N/A
Completed	`NCT03683316` - Work of Breathing and Kangaroo Mother Care
Recruiting	`NCT04429906` - Diagnostic Study of Huami Smart Wearable Device
Completed	`NCT05784103` - Comparison of Tissue Oxygenation Measurement Using Multimodal Devices	N/A
Recruiting	`NCT06283914` - Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry
Recruiting	`NCT03873298` - Inhaled NO in IPF and COPD During 6 Minute Walk Test	Phase 2
Completed	`NCT03439202` - Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.	N/A
Recruiting	`NCT05022264` - Remote Investigation and Assessment of Vital Signs
Completed	`NCT02834845` - Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension	Phase 4
Suspended	`NCT04252547` - Effect of Kangaroo Care on Test Weighing	N/A
Completed	`NCT04346498` - Can Kangarooing Small Babies on the Back of a Mother Keep Them Warm and Stable	N/A
Completed	`NCT02127333` - Role of Oxygen for Vascular Dysfunction	N/A
Not yet recruiting	`NCT05451875` - Comparison of Continuous Non-invasive All Vital Signs Monitoring Devices With Invasive Gold Standard for Children
Completed	`NCT05683210` - Comparison of The Effects of Initial Oral Feeding by Cup and Bottle-Feeding of Preterm Infants	N/A
Completed	`NCT02017691` - Cerebral Oxygenation to Guide Supplemental Oxygen	Phase 1/Phase 2
Completed	`NCT05709262` - Comparison of Different Walk and Performance Test in Detecting Silent Hypoxia
Completed	`NCT05192785` - The Effects Incentive Spirometry Use in Coronary Artery Bypass Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of Color

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms