Pulse oximeter accuracy put to the test in Low-Oxygen study
NCT ID NCT07408388
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study checks how accurately a pulse oximeter (a device that shines light through skin to measure blood oxygen) works during controlled low-oxygen breathing. About 48 healthy volunteers aged 18-50 will breathe a special gas mixture to safely lower their oxygen levels. Researchers will compare the device's readings to actual blood samples to see how well it performs.
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 the accuracy of pulse oximeters, leading to better monitoring of oxygen levels in patients.
- What could go wrong
- This is a small, early-stage study in healthy volunteers, so results may not apply to sick patients. The device may still have limitations in real-world use.
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
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Healthy adult volunteers. At least 48 new subjects will be enrolled. Subjects will be selected with reference to ISO and FDA requirements to ensure appropriate representation across skin tone categories (Monk Skin Tone scale) and sex.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * The subject is male or female, aged 18 to 50. * The subject is in good general health with no evidence of any medical problems * The subject is fluent in both written and spoken English. * The subject has provided informed consent and is willing to comply with the study procedures. Exclusion Criteria: 1. The subject has a BMI above 40 2. The subject has blood pressure above 160 systolic or 95 diastolic 3. The subject has a known history of heart disease, lung disease, kidney or liver disease. 4. Diagnosis of asthma, sleep apnea, or use of CPAP. 5. Subject has diabetes. 6. Subject has a clotting disorder. 7. The subject has 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. (COHb\<3%, MetHb\<2%, ctHb\>10 g/dL). 8. The subject has any other serious systemic illness. 9. The subject has smoked in the last 12 hours. 10. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly. 11. The subject has a history of fainting or vasovagal response. 12. The subject has a history of sensitivity to local anesthesia. 13. The subject has a diagnosis of Raynaud's disease. 14. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). 15. The subject is pregnant, lactating or trying to get pregnant. 16. Subjects who have uneven skin tones at the forehead or the sensor site. 17. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures. 18. 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Vital Sign Research Group
San Francisco, California, 94107, United States
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