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

NCT05995613 | Completed

• 1 other identifier: 23-0812
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Oxygen Saturation

Outcome Measures

Primary Outcomes (3)

• Initial Device Safety Questionnaire

  Device safety and comfort will be assessed by qualitative survey. All questions are rated from 1-5, where 1 is Strongly Disagree, and 5 is Strongly Agree. In the initial survey, the final 7 pertain to safety. The Safety Sub-Score is determined by the latter 7 questions, making the score range from 7-35. In this case, a higher number indicates a better outcome.

  10 minutes following the 90 minute testing period

• Initial Device Comfort Questionnaire

  Device comfort will be assessed by qualitative survey. All questions are rated from 1-5, where 1 is Strongly Disagree, and 5 is Strongly Agree. In the initial 19-question survey, the first 12 pertain to comfort. The Comfort Sub-Score is determined by the first 12 questions, making the score range from 12-60. In this case, a higher number indicates a better outcome.

  10 minutes following the 90 minute testing period

• Final Device Safety Questionnaire

  Device safety will be assessed by qualitative survey. All questions are rated from 1-5, where 1 is "Strongly Disagree", and 5 is "Strongly Agree" and scores range from 9-45, where a higher score indicates a better outcome. The following 9 questions are asked: "I have noticed a change in skin condition since wearing the device"; "I have experienced a rash since wearing the device"; "I have experienced itching since wearing the device"; "I have experienced swelling since wearing the device"; "I have experienced a burning sensation since wearing the device"; "I have experienced vesicles blistering since wearing the device"; "I have experienced irregular warming of the skin since wearing the device"; "I have experienced a stinging sensation since wearing the device"; and "I have experienced a change in skin sensitivity since wearing the device."

  Two 10-minute sessions, one 2 days after the testing session, and one 4 days after the testing session

Secondary Outcomes (2)

• Epidermal Melanin Estimation

  First 10 minutes of the 90-minute testing session, during the calibration phase

• Blood Oxygen Level Estimation

  The latter 80 minutes of the testing period on the testing day, following the calibration period

Study Arms (1)

MABOS

Participants will have one FDA-approved pulse oximeter (Nonin PureSat) along with our novel pulse oximeter placed to acquire 90 minutes of biometric data

Device: MABOS; Device: Nonin PureSat

Interventions

MABOS DEVICE

The novel pulse oximeter (MABOS) will be placed to acquire two biometrics: blood oxygen saturation and epidermal melanin concentration.

Also known as: pulse oximeter

MABOS

Nonin PureSat DEVICE

An FDA approved pulse oximeter will be placed to acquire blood oxygen saturation.

MABOS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals of African, East Asian, and European descent; equal proportions of male and female individuals from each group.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Study Officials

• Wubin Bai, Ph.D.

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: September 6, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 1, 2024
• Last Updated: March 11, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)