Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06142019

Conditions

Hypoxia

Skin Pigmentation

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Controlled desaturation (hypoxemia)

Study Details

Brief summary:

The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxygen. This study will be done on healthy male or females between the age group of 18-50.

Conditions

Hypoxia

Skin Pigmentation

Study ID

NCT06142019

Start date

Nov 29, 2021

Status verified date

Aug, 2025

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Controlled desaturation (hypoxemia)

Stable hypoxemia is created in healthy subjects by having them breathe hypoxic air mixtures

Primary outcome measure

  • SpO2 [ Time Frame: 08/01/2025 ]

Central Contacts and Locations

Central contacts

Locations

Hypoxia Lab, UCSF Department of Anesthesia and Perioperative Care

Recruiting

San Francisco, California, United States, 94143

Contacts

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-09-02.