Testing the accuracy of Owlet pulse oximeters during low oxygen levels

Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus

This study is testing how accurately the Owlet pulse oximeter measures oxygen levels in healthy adults when their oxygen levels are lowered and while they move around.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 49 Years
• Sex: All
• Sponsor: Owlet Baby Care, Inc. (industry)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06850610 on ClinicalTrials.gov

What this trial studies

This study evaluates the accuracy of the Owlet OSS 3.0 pulse oximeter by comparing its readings against arterial blood samples taken from healthy adult participants experiencing controlled hypoxia. Participants will undergo a series of oxygen saturation levels ranging from 100% to 70%, while also being subjected to various movements to assess the device's performance under motion. The study aims to gather data on the pulse oximeter's reliability in detecting oxygen levels accurately during these conditions. The testing process will take approximately an hour and 15 minutes for each participant.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-40 who are fluent in English and can comply with study procedures.

Not a fit: Patients with obesity, chronic diseases, or conditions affecting oxygen levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the reliability of pulse oximeters, improving patient monitoring in clinical settings, especially for infants.

How similar studies have performed: While studies on pulse oximeter accuracy exist, this specific approach of testing under controlled hypoxia with motion is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. The subject is in good general health with no evidence of any medical problems.
2. The subject is fluent in both written and spoken English.
3. 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. The subject has diabetes.
5. The subject has a clotting disorder.
6. 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.
7. The subject has any other serious systemic illness.
8. The subject has a carboxyhemoglobin level greater than 3% (determined during the first sample)
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.

Where this trial is running

San Francisco, California

• Vital Signs Research Group — San Francisco, California, United States (RECRUITING)

Study contacts

• Study coordinator: Alisa L Niksch

Conditions: Hypoxia, hypoxia, pulse oximeter, accuracy, Owlet