Oxygen SaturationNCT05995613
Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of Color
An observational study of Oxygen Saturation, run by University of North Carolina, Chapel Hill at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation
- What is being tested?
- MABOS and Nonin PureSat
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals of African, East Asian, and European descent; equal proportions of male and female individuals from each group.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Evaluation of Wearable Melanin-Adjusted Blood Oxygen Sensor (MABOS) for Improved Accuracy in Patients of Color
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
- Being tested
- MABOS, Nonin PureSat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MABOSDevice
Also called pulse oximeter
The novel pulse oximeter (MABOS) will be placed to acquire two biometrics: blood oxygen saturation and epidermal melanin concentration.
Nonin PureSatDevice
An FDA approved pulse oximeter will be placed to acquire blood oxygen saturation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: MABOS; Device: Nonin PureSat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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."
Measured: 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
Confirming the device's ability to differentiate skin tone using 3 wavelengths of light by comparison to a spectrometer.
Metric of Accuracy: Take the average 410 nm light absorption of each individual (an average of intensity of absorbance over time during the 10-minute calibration period), using both the spectrometer and the device. Find the regression line that best fits the 12 data points (where each data point is a paired observation of spectrometer and device 410-nm light absorption for a given participant). A positive R value, with an R-squared value >80% for a simple linear regression, is considered a positive indication of a trend.
Measured: First 10 minutes of the 90-minute testing session, during the calibration phase
Blood Oxygen Level Estimation
Comparing the device's blood oxygen estimation to the FDA approved device to confirm accuracy.
Metric of Accuracy: Upon calibration of the device, each 60-second sample will constitute one 'estimate' of SpO2 (blood oxygen saturation). For the latter 80 minutes of the study, 80 samples will be derived. Each sample will be compared to what was recorded by the FDA-approved oximeter. The comparison will be accomplished by finding the regression line that best fits the cumulative 80-minute data from all 12 participants. A positive R value, with an R-squared value >80% for a simple linear regression, is considered a positive indication of a trend.
Measured: The latter 80 minutes of the testing period on the testing day, following the calibration period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start6 May 2023
- Primary completion15 May 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wubin Bai, Ph.D., Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995613
- Sponsor's protocol ID
- 23-0812
- Status last verified
- Feb 2026
- First submitted
- 8 Aug 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wearable Melanin-Adjusted Blood Oxygen Sensor (MABOS) for Improved Accuracy in Patients of Color
- ClinicalTrials.gov ID
- NCT05995613
- Acronym / sponsor ID
- 23-0812
- Conditions
- Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MABOS | – | Device: MABOS, Device: Nonin PureSatParticipants will have one FDA-approved pulse oximeter (Nonin PureSat) along with our novel pulse oximeter placed to acquire 90 minutes of biometric data |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals of African, East Asian, and European descent; equal proportions of male and female individuals from each group.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MABOSAlso: pulse oximeterThe novel pulse oximeter (MABOS) will be placed to acquire two biometrics: blood oxygen saturation and epidermal melanin concentration. | Device | MABOS |
| Nonin PureSatAn FDA approved pulse oximeter will be placed to acquire blood oxygen saturation. | Device | MABOS |
Primary outcome
Initial Device Safety Questionnaire
Time frame: 10 minutes following the 90 minute testing period
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.
Initial Device Comfort Questionnaire
Time frame: 10 minutes following the 90 minute testing period
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.
Final Device Safety Questionnaire
Time frame: Two 10-minute sessions, one 2 days after the testing session, and one 4 days after the testing session
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."
2 secondary outcomes
Epidermal Melanin Estimation
Time frame: First 10 minutes of the 90-minute testing session, during the calibration phase
Blood Oxygen Level Estimation
Time frame: The latter 80 minutes of the testing period on the testing day, following the calibration period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wubin Bai, Ph.D. principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Saturation, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial Device Safety Questionnaire (time frame: 10 minutes following the 90 minute testing period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.