Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

Running, not enrolling

Conditions studied: Hypoxia

In brief

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with healthy volunteers at rest.

Key facts

Study ID

NCT07408388

Run by

Nihon Kohden

People needed

48

Starts

2025-12-03

Expected to finish

2027-12-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• The subject has a BMI above 40
• The subject has blood pressure above 160 systolic or 95 diastolic
• The subject has a known history of heart disease, lung disease, kidney or liver disease.
• Diagnosis of asthma, sleep apnea, or use of CPAP.
• Subject has diabetes.
• Subject has a clotting disorder.
• 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).
• The subject has any other serious systemic illness.
• The subject has smoked in the last 12 hours.
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
• The subject has a history of fainting or vasovagal response.
• The subject has a history of sensitivity to local anesthesia.
• The subject has a diagnosis of Raynaud's disease.
• The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
• The subject is pregnant, lactating or trying to get pregnant.
• Subjects who have uneven skin tones at the forehead or the sensor site.
• The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
• The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.

Where it is running

• Vital Sign Research Group — San Francisco, California, United States

Full record on ClinicalTrials.gov

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