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Can your pulse oximeter be trusted? new study tests accuracy across skin tones

NCT ID NCT06142019

Knowledge-focused Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study checks how well pulse oximeters measure blood oxygen during mild to severe low oxygen levels in 10,000 healthy adults aged 18-50. Researchers compare the device's reading to a precise blood test, and also look at how skin pigmentation affects accuracy. The goal is to make sure these devices work for everyone.

What this could mean

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

What this could lead to
If successful, this could improve pulse oximeter accuracy for people with different skin tones, leading to better oxygen monitoring in hospitals.
What could go wrong
This is an observational study in healthy volunteers, not a treatment trial. Results may not apply to sick patients or real-world settings.

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

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Sep 2028

An estimate. End dates often move.

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

Study population consists of healthy volunteers between 18-50 years of age across all ethnic and racial backgrounds.

Ages

18 to 50 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: 1. The subject is male or female, aged ≥18 and \<50. 2. The subject is in good general health with no evidence of any medical problems. 3. The subject is fluent in both written and spoken English. 4. The subject has provided informed consent and is willing to comply with the study procedures. Exclusion Criteria: 1. The subject is obese (BMI\>35). 2. The subject has a known history of heart disease, lung disease, kidney or liver disease. 3. Diagnosis of asthma, sleep apnea, or use of CPAP. 4. Subject has diabetes. 5. Subject has a clotting disorder. 6. The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. 7. The subject has any other serious systemic illness. 8. The subject is a current smoker. 9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. 10. The subject has a history of fainting or vasovagal response. 11. The subject has a history of sensitivity to local anesthesia. 12. The subject has a diagnosis of Raynaud's disease. 13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). 14. The subject is pregnant, lactating or trying to get pregnant. 15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. 16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

Hypoxia skin pigmentation disorder

As listed by the trial registrant

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

Hypoxia Skin pigmentation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hypoxia Lab, UCSF Department of Anesthesia and Perioperative Care

    RECRUITING

    San Francisco, California, 94143, United States

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