HypoxiaNCT06850610
Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus
A study testing Pulse oximeter accuracy under hypoxic conditions in people with Hypoxia, run by Owlet Baby Care, Inc. at 1 site in United States.
Trial summary
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 oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Pulse oximeter accuracy under hypoxic conditions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 6 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- The subject is obese (BMI>35).
- The subject has a known history of heart disease, lung disease, kidney or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- The subject has diabetes.
- The 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.
Show all 16Show fewer
- The subject has any other serious systemic illness.
- The subject has a carboxyhemoglobin level greater than 3% (determined during the first sample)
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vital Signs Research Group
San Francisco, California, 94107
About this study
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 oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen saturations. The arterial blood sample is processed in a device called a multi-wavelength hemoximeter and compared to the simultaneous oximeter reading. During each set level of oxygen the participant may be asked to have a motion simulator device apply different types of movement to their hands to assess the pulse oximeter's accuracy during motion. This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age.
Testing should require approximately an hour and 15 minutes of the participant's time.
Read the detailed description
Several separate cohorts of study participants will be recruited and enrolled in accordance with laboratory time and staff availability. After informed consent is performed, a local anesthetic will be injected around the radial artery, and a 22-gauge radial artery catheter will be placed. Pulse oximeters/sensors under test will be attached to the subject along with FDA-cleared reference pulse oximeters. ECG electrodes will be placed on the subject to monitor the subject's heart rate. The Owlet Sensor under test placement and serial numbers will be documented for each subject. Subjects will be placed in a seated, semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia.
Each subject will undergo two cycles of three different hypoxia plateaus in the 90-100%, 80-90% and 70-80% range, with an average of 20-24 data pairs with a maximum range of 17-30 data points. Study subjects may be have a motion protocol applied to test the Owlet Sensor's accuracy during variable frequencies and amplitudes of movement.
The motions applied by the motion simulator will be 1) 2 Hz sine 10mm 2) 3 Hz sine 10mm 3) 4 Hz sine 10mm 4 ) Random motion 30mm peak, 20 to 200 mm / sec These motions are applied with the fingers tapping on the first cycle of hypoxia and rubbing on the second cycle. The subject will not perform the motion during the first blood sample of each plateau but will during the 2-4th samples separated by 30 seconds.
90% of participants will have at least one usable data point below 85% and at least 69% of subjects will have one usable data pair between 70-80%. As this procedure is evaluating a single user device, a new sensor will be applied to each study participant.
The skin tone distribution of subjects will be divided into 3 groups based on the 10 point Monk skin tone scale (MST) and Individual Typology Angle (ITA) measured by an ISO compliant colorimeter at the forehead and at the anatomic location of sensor placement. MST will be assessed with a printed color swatch that has been verified by a colorimeter. Enrollment of subjects must follow these criteria:
- At least 25% of subjects will be Monk Skin Tone (MST) 1-4 with an ITA greater than 30
- At least 25% of subjects will be MST 5-7 and have an ITA between -30 and 30
- At least 25%-of subjects will be MST 8-10 with an ITA less than -30 (with one half of MST 8-10 subjects having an ITA of less than -50)
- Conditions
- Hypoxia
- Being tested
- Pulse oximeter accuracy under hypoxic conditions
- Keywords
- hypoxia, pulse oximeter, accuracy, Owlet
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeter accuracy under hypoxic conditionsDiagnostic test
This study will specifically evaluate the accuracy of the Owlet pulse oximeter sensor, currently FDA cleared for infants 1-18 months of age in an expanded hypoxia lab trial.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia Plateau Protocol | Experimental | 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. Receives: Diagnostic Test: Pulse oximeter accuracy under hypoxic conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Oximeter Accuracy Measures
- Overall Accuracy: Arms is less than 3%.
- Non-Disparate Performance Evaluation 1: Among pairwise comparisons of MST groups 1-4, 5-7, and 8-10, the largest difference in SpO2 bias is less than 3.5% for the interval 70% ≤ SaO2≤ 85% and less than 1.5% for 85%< SaO2 ≤ 100%.
- Non-Disparate Performance Evaluation 2: For a 100-point change in emitter sensor site ITA, the difference in SpO2 bias is less than 3.5% for 70% ≤ SaO2≤ 85% and less than 1.5% for 85%< SaO2 ≤ 100%
Measured: From enrollment to completion of 6 plateaus of hypoxia over an approximate 75 minute period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start24 Feb 2025
- Primary completion6 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlet Baby Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koa Gudelunas, Study director, Vital Signs Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850610
- Sponsor's protocol ID
- OWL PR0009
- Status last verified
- Aug 2025
- First submitted
- 13 Feb 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data collected during the course of this study are specifically intended for a regulatory submission and may or may not be shared publicly.
Publications
Cohen PR, DiMarco MA, Geller RL, Darrisaw LA. Colorimetric Scale for Skin of Color: A Practical Classification Scale for the Clinical Assessment, Dermatology Management, and Forensic Evaluation of Individuals With Skin of Color. Cureus. 2023 Nov 1;15(11):e48132. doi: 10.7759/cureus.48132. eCollection 2023 Nov.
PubMed 38046737Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004.
PubMed 15791098Okunlola OE, Lipnick MS, Batchelder PB, Bernstein M, Feiner JR, Bickler PE. Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Respir Care. 2022 Feb;67(2):252-257. doi: 10.4187/respcare.09795. Epub 2021 Nov 12.
PubMed 34772785Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056/NEJMc2029240. No abstract available.
PubMed 33326721
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus
- ClinicalTrials.gov ID
- NCT06850610
- Acronym / sponsor ID
- OWL PR0009
- Conditions
- Hypoxia
- Keywords
- hypoxia, pulse oximeter, accuracy, Owlet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Owlet Baby Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen saturations. The arterial blood sample is processed in a device called a multi-wavelength hemoximeter and compared to the simultaneous oximeter reading. During each set level of oxygen the participant may be asked to have a motion simulator device apply different types of movement to their hands to assess the pulse oximeter's accuracy during motion. This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age.
Testing should require approximately an hour and 15 minutes of the participant's time.
Detailed description
Several separate cohorts of study participants will be recruited and enrolled in accordance with laboratory time and staff availability. After informed consent is performed, a local anesthetic will be injected around the radial artery, and a 22-gauge radial artery catheter will be placed. Pulse oximeters/sensors under test will be attached to the subject along with FDA-cleared reference pulse oximeters. ECG electrodes will be placed on the subject to monitor the subject's heart rate. The Owlet Sensor under test placement and serial numbers will be documented for each subject. Subjects will be placed in a seated, semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia.
Each subject will undergo two cycles of three different hypoxia plateaus in the 90-100%, 80-90% and 70-80% range, with an average of 20-24 data pairs with a maximum range of 17-30 data points. Study subjects may be have a motion protocol applied to test the Owlet Sensor's accuracy during variable frequencies and amplitudes of movement.
The motions applied by the motion simulator will be 1) 2 Hz sine 10mm 2) 3 Hz sine 10mm 3) 4 Hz sine 10mm 4 ) Random motion 30mm peak, 20 to 200 mm / sec These motions are applied with the fingers tapping on the first cycle of hypoxia and rubbing on the second cycle. The subject will not perform the motion during the first blood sample of each plateau but will during the 2-4th samples separated by 30 seconds.
90% of participants will have at least one usable data point below 85% and at least 69% of subjects will have one usable data pair between 70-80%. As this procedure is evaluating a single user device, a new sensor will be applied to each study participant.
The skin tone distribution of subjects will be divided into 3 groups based on the 10 point Monk skin tone scale (MST) and Individual Typology Angle (ITA) measured by an ISO compliant colorimeter at the forehead and at the anatomic location of sensor placement. MST will be assessed with a printed color swatch that has been verified by a colorimeter. Enrollment of subjects must follow these criteria:
- At least 25% of subjects will be Monk Skin Tone (MST) 1-4 with an ITA greater than 30
- At least 25% of subjects will be MST 5-7 and have an ITA between -30 and 30
- At least 25%-of subjects will be MST 8-10 with an ITA less than -30 (with one half of MST 8-10 subjects having an ITA of less than -50)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoxia Plateau Protocol | Experimental | Diagnostic Test: Pulse oximeter accuracy under hypoxic conditionsStudy 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 may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- The subject is obese (BMI>35).
- The subject has a known history of heart disease, lung disease, kidney or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- The subject has diabetes.
- The subject has a clotting disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse oximeter accuracy under hypoxic conditionsThis study will specifically evaluate the accuracy of the Owlet pulse oximeter sensor, currently FDA cleared for infants 1-18 months of age in an expanded hypoxia lab trial. | Diagnostic test | Hypoxia Plateau Protocol |
Primary outcome
Pulse Oximeter Accuracy Measures
Time frame: From enrollment to completion of 6 plateaus of hypoxia over an approximate 75 minute period.
* Overall Accuracy: Arms is less than 3%. * Non-Disparate Performance Evaluation 1: Among pairwise comparisons of MST groups 1-4, 5-7, and 8-10, the largest difference in SpO2 bias is less than 3.5% for the interval 70% ≤ SaO2≤ 85% and less than 1.5% for 85%< SaO2 ≤ 100%. * Non-Disparate Performance Evaluation 2: For a 100-point change in emitter sensor site ITA, the difference in SpO2 bias is less than 3.5% for 70% ≤ SaO2≤ 85% and less than 1.5% for 85%< SaO2 ≤ 100%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 38046737Cohen PR, DiMarco MA, Geller RL, Darrisaw LA. Colorimetric Scale for Skin of Color: A Practical Classification Scale for the Clinical Assessment, Dermatology Management, and Forensic Evaluation of Individuals With Skin of Color. Cureus. 2023 Nov 1;15(11):e48132. doi: 10.7759/cureus.48132. eCollection 2023 Nov.
- Background: PubMed 15791098Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004.
- Background: PubMed 34772785Okunlola OE, Lipnick MS, Batchelder PB, Bernstein M, Feiner JR, Bickler PE. Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Respir Care. 2022 Feb;67(2):252-257. doi: 10.4187/respcare.09795. Epub 2021 Nov 12.
- Background: PubMed 33326721Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056/NEJMc2029240. No abstract available.
- A guide to the skin tone stratification used for assessment of accuracy across all represented populations.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data collected during the course of this study are specifically intended for a regulatory submission and may or may not be shared publicly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koa Gudelunas study director
Vital Signs Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse oximeter accuracy under hypoxic conditions in people with Hypoxia, run by Owlet Baby Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Oximeter Accuracy Measures (time frame: From enrollment to completion of 6 plateaus of hypoxia over an approximate 75 minute period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06850610, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.