Pulse Oximeter Accuracy for Hypoxia

Overseen By Alisa L Niksch

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Owlet Baby Care, Inc.

Disqualifiers: Obesity, Heart disease, Lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 75 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the accuracy of a pulse oximeter in measuring blood oxygen levels, even when levels are low or during movement. It focuses on the Owlet OSS 3.0 sensor, typically used for infants. Participants will experience periods of lower oxygen levels while researchers check the sensor's accuracy. Healthy adults without conditions affecting the heart, lungs, or blood circulation are ideal candidates. As an unphased trial, this study allows participants to contribute to advancements in non-invasive monitoring technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy participants with no medical problems, it's likely that those on regular medications may not qualify.

What prior data suggests that this pulse oximeter is safe for use in this study?

Research has shown that the Owlet OSS 3.0 sensor is generally safe and easy to use. Devices approved by the FDA have used it to check babies' oxygen levels, indicating it meets safety standards for infants. Studies indicate that this sensor accurately measures oxygen levels, even when oxygen is low or the person is moving. Additionally, these devices rarely give false alarms, demonstrating reliable performance.

Overall, while the testing process might cause minor discomfort, such as using a motion simulator, the sensor itself has not been linked to any serious side effects. Participants can expect a safe experience during this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to test the accuracy of the Owlet OSS 3.0 pulse oximeter under conditions that mimic real-life challenges. Unlike traditional pulse oximeters that might struggle to provide accurate readings during movement or in low oxygen environments, this device is being examined for its performance during standardized oxygen desaturation events. The goal is to see if it can reliably measure blood oxygen levels even when the user is moving, potentially offering a more dependable tool for monitoring hypoxia in everyday settings.

What evidence suggests that this pulse oximeter is effective for measuring hypoxia?

Research shows that the Owlet OSS 3.0 sensor effectively measures oxygen levels in the blood. In past studies, the sensor measured oxygen saturation (the amount of oxygen in the blood) with about 3% accuracy compared to actual blood tests. This indicates that its readings closely match real oxygen levels. For babies using extra oxygen, the device consistently maintained the target oxygen level range of 91-95%. Overall, the Owlet OSS 3.0 has proven reliable whether the person is still or moving. Participants in this trial will undergo standardized plateaus of oxygen desaturation to evaluate the accuracy of the Owlet noninvasive pulse oximeter during both motion and nonmotion conditions. ^{1 2 6 7 8}

Who Is on the Research Team?

Koa Gudelunas

Principal Investigator

Vital Signs Research Group

Are You a Good Fit for This Trial?

This trial is for young, healthy adults. Participants must be able to undergo brief periods of reduced oxygen levels and have blood samples taken from their wrist artery. They should also be comfortable with a motion simulator device being applied to their hands.

Inclusion Criteria

I am fluent in English, both in writing and speaking.

The subject has provided informed consent and is willing to comply with the study procedures.

I am in good health with no major medical issues.

Exclusion Criteria

The subject has a history of sensitivity to local anesthesia.

The subject is pregnant, lactating or trying to get pregnant.

The subject has any other condition, which in the opinion of the investigators, would make them unsuitable for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo standardized plateaus of oxygen desaturation to evaluate the accuracy of the Owlet noninvasive pulse oximeter during motion and nonmotion conditions

75 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Owlet OSS 3.0

Trial Overview The study is testing the accuracy of the Owlet OSS 3.0 pulse oximeter by comparing its readings against arterial blood samples during controlled hypoxia (low oxygen levels) and simulated hand movements in participants.

How Is the Trial Designed?

Group I: Hypoxia Plateau Protocol Experimental Treatment 1 Intervention

Study participants that all undergo standardized plateaus of oxygen desaturation to evaluate the accuracy of the Owlet noninvasive pulse oximeter during motion and nonmotion conditions.

Who Is Running the Clinical Trial?

Owlet Baby Care, Inc.

Lead Sponsor

Trials

11

Recruited

9,600+

Published Research Related to This Trial

A systematic review of 22 studies found that 75% of pulse oximeters are accurate in adults with poor peripheral perfusion, particularly newer models that use advanced algorithms.

Oximeters placed on the earlobe showed greater measurement accuracy compared to those placed on the fingertip, highlighting the importance of placement in obtaining reliable readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximeters in measuring oxygen saturation in patients with poor peripheral perfusion: a systematic review. Poorzargar, K., Pham, C., Ariaratnam, J., et al.[2022]

In a study using an in vitro circulation system, a benchtop pulse oximeter showed good accuracy in measuring oxygen saturation across various levels of anemia, except at the most severe anemia (10% hematocrit).

The handheld and fingertip pulse oximeters demonstrated decreased accuracy, particularly at lower hematocrit levels, highlighting that severe anemia can significantly affect pulse oximeter performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying pulse oximeter accuracy during hypoxemia and severe anemia using an in vitro circulation system. Gylys, R., Feiner, J., Pologe, J., et al.[2023]

In a study of 33 open-heart surgery patients, three different pulse oximeters provided reliable readings of oxygen saturation and heart rate even during low cardiac index and low peripheral temperature conditions.

The accuracy of these oximeters was consistent with normal physiological states, suggesting they can be trusted in critical situations post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of three pulse oximeters at low cardiac index and peripheral temperature. Pälve, H., Vuori, A.[2019]

A study tested the accuracy of pulse oximeters from 14 manufacturers on 125 subjects, revealing significant variability in their performance, especially at low oxygen saturation levels (O2Hb).

Most pulse oximeters tended to underestimate oxygen saturation, with some models showing substantial bias and poor precision, indicating that not all devices are equally reliable for monitoring patients with low oxygen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Errors in 14 pulse oximeters during profound hypoxia. Severinghaus, JW., Naifeh, KH., Koh, SO.[2019]

In a study of 193 ICU patients, four different pulse oximeters were tested against arterial blood gas measurements, revealing significant bias in their SpO2 readings; the Philips oximeter overestimated oxygen saturation while the Nonin, Nellcor, and Masimo oximeters underestimated it.

The ability of these oximeters to detect moderate hypoxemia varied significantly, with the Nonin oximeter detecting hypoxemia in 92% of cases, while the Philips oximeter only detected it in 11%, highlighting potential clinical implications for oxygen therapy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Multiple Pulse Oximeters in Stable Critically Ill Patients. Blanchet, MA., Mercier, G., Delobel, A., et al.[2023]

During induced hypoxemia, pulse oximeters were generally accurate when oxygen saturation was high, but they consistently underreported saturation levels when actual values dropped to 75% or lower, highlighting a limitation in their performance under severe conditions.

Among the tested oximeters, the Ohmeda 3740 and Nellcor N200 were the quickest to detect desaturation, while the Novametrix Oxypleth was notably faster in returning to baseline saturation after resaturation with 100% oxygen, indicating variability in response times among different models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse oximeter performance during desaturation and resaturation: a comparison of seven models. Trivedi, NS., Ghouri, AF., Lai, E., et al.[2019]

In a study involving 25 healthy volunteers, the accuracy of four different pulse oximeters decreased significantly as arterial oxygen saturation (SaO2) levels fell below 90%, leading to misleading SpO2 readings that were higher than actual levels.

The findings highlight the importance of using co-oximetry to confirm arterial blood oxyhemoglobin saturation during severe hypoxemia, as pulse oximeters may not provide reliable readings in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximetry during hypoxemia. Thrush, D., Hodges, MR.[2022]

Among three iPhone pulse oximetry applications tested on 191 patients, the iOx app showed the best correlation with standard pulse oximetry, but still misclassified about 24% of patients' hypoxia status.

The other two apps, POx and Ox, demonstrated very poor accuracy in measuring SpO2 and detecting hypoxia, indicating that these applications should not be relied upon for accurate assessments in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of iPhone oximetry apps: A comparison with standard pulse oximetry measurement in the emergency department. Jordan, TB., Meyers, CL., Schrading, WA., et al.[2021]

Pulse oximeters have been found to be less accurate in patients with darker skin, which can lead to missed diagnoses of hypoxemia, highlighting a significant safety concern in their use.

The authors propose five key areas for research and regulatory changes to improve oximeter accuracy, including diversifying study subject pools and enhancing transparency in performance reporting, which could help ensure safer and more effective use of these devices across all skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Okunlola, OE., Lipnick, MS., Batchelder, PB., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06771206

Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in ... The primary outcome of the study is the accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12353594/

The Diagnostic Accuracy of an Over-The-Counter Infant ... The Owlet OSS 3.0 (Owlet Baby Care Inc., Lehi, UT) is a non-invasive ... Infants on supplemental oxygen had uniform oxygen saturation targets from 91–95%.

3. trialstoday.org trialstoday.org/trial/NCT06850610

Accuracy Of The Owlet OSS 3.0 During Standardized ... This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test ...

4. trial.medpath.com trial.medpath.com/clinical-trial/eff49fc5b11c675e/nct06771206-owlet-oss-30-sensor-neonatal-accuracy

Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the ... The primary hypothesis is that the Owlet OSS 3.0 Sensor will measure SpO2 values within +/- 3% ARMS compared to SaO2 measurements. Each study ...

5. withpower.com withpower.com/trial/phase-hypoxia-1-2025-723d1

Pulse Oximeter Accuracy for Hypoxia · Info for Participants The research suggests that modern pulse oximeters, like the Owlet OSS 3.0, are generally accurate in measuring oxygen levels even in patients with poor blood ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06850610

Accuracy Of The Owlet OSS 3.0 During Standardized ... This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test pulse ...

7. indusmedtechsolutions.com indusmedtechsolutions.com/assets/documents/Accuracy_measure_of_FDA-cleared_babysat.pdf

Accuracy Evaluation of the FDA-Cleared BabySat™ ... FDA-cleared prescription pulse oximeters are required to have a minimum average (mean) accuracy, reported as Accuracy Root Mean Square or Arms, within 3% of ...

8. fn.bmj.com fn.bmj.com/content/early/2025/05/12/archdischild-2025-328540

Diagnostic accuracy of an over-the-counter infant pulse ... An over-the-counter infant pulse oximeter had high specificity for bradycardia and hypoxaemia events consistent with a low false alarm rate.