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Can a Melanin-Sensing oximeter end hidden oxygen reading bias?

NCT ID NCT05995613

Diagnosis Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests a new wearable device, MABOS, that aims to adjust blood oxygen readings based on skin melanin levels. Standard pulse oximeters can be less accurate on darker skin, and this study enrolls healthy adults with diverse skin tones to see if MABOS is safe, comfortable, and able to estimate melanin and oxygen. Participants wear both MABOS and a standard oximeter while performing breathing exercises, and their skin is monitored for irritation. The goal is to gather early evidence on whether this approach could improve oxygen monitoring for people of color.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A novel wearable pulse oximeter (MABOS) that measures blood oxygen and skin melanin, compared to a standard FDA-approved pulse oximeter.
What this could lead to
If it works, this could lead to more accurate blood oxygen monitoring for people with darker skin, reducing hidden risks from inaccurate readings.
What could go wrong
This is a very early, small feasibility study focused on safety and basic function, not proof of accuracy. The device may not perform better than existing monitors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

9 people

The number who actually took part.

Started

May 2023

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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 * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oxygen saturation

Contacts and locations

Locations

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

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