Pulse Oximeter ValidationNCT06771206
Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
A study testing Owlet pulse oximeter neonatal accuracy validation in people with Pulse Oximeter Validation, run by Owlet Baby Care, Inc. at 2 sites in United States.
Trial summary
The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Pulse Oximeter Validation
- What is being tested?
- Owlet pulse oximeter neonatal accuracy validation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than or equal to 44 weeks corrected gestational age
- Weight equal or greater than 1500g
- Subjects with standard of care (SOC) arterial blood sampling line already in place at time of enrollment, with anticipated arterial blood gas measurements as part of their plan of care
Who cannot join
- Subjects with underdeveloped skin as assessed by a study investigator and/or reported by the clinical care team
- Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements
- Potential subjects on extracorporeal membrane oxygenation (ECMO) or other mechanical circulatory support
- Arterial line is placed in a preductal position with the potential of pulmonary to systemic shunting
- Subjects undergoing cooling protocol/therapeutic hypothermia
- Subjects who are deemed too clinically unstable by the Principal Investigator (PI), sub-investigator and/or clinical care team to participate in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Guy Alvarez, PhD contact
United States2 sites, 2 recruiting
- Recruiting
University of Alabama Birmingham - Children's of Alabama
Birmingham, Alabama, 35233
Kristal Hock, MSN, (205) 996-3313, KristalHock@uabmc.edu
Michael A Brock, M.D.
- Recruiting
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454
Amy Kodet, MPP, (612) 625-6678, kodet006@umn.edu
Gwenyth Fischer, M.D.
About this study
The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date.
The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.
Read the detailed description
This is a prospective, non-randomized, single arm study to evaluate SpO2 performance of the Owlet OSS 3.0 pulse oximetry Sensor in the neonate population up to 44 weeks corrected gestational age using convenience sampling of arterial blood gas samples as a part of routine clinical monitoring.
The Owlet OSS 3.0 Sensor is the component of the Owlet Dream Sock (DEN220091) and BabySat (K222597), both Food and Drug Administration (FDA) cleared pulse oximeters for infants 1-18 months in 2023. This component performs the signal acquisition and analysis to estimate pulse rate and SpO2 readings.
The study will enroll between 20-100 neonates weighing a minimum of 1500g in the hospital setting with available arterial line access and arterial blood gas samples being performed as part of planned patient management. No additional blood gas samples will be taken beyond clinical care indications.
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 from arterial blood gas samples as determined by a root mean square (ARMS) calculation.
Secondary outcomes will include:
- Bias in the Owlet OSS 3.0 Sensor SpO2 vs SaO2 defined as (Owlet OSS 3.0 Sensor SpO2 - SaO2).
- Precision of the Owlet OSS 3.0 Sensor SpO2 vs SaO2 defined as ABS (Owlet OSS 3.0 Sensor SpO2 - SaO2).
Accuracy will be stratified by a number of demographic elements, including by a 10 point skin tone scale and Individual Typology Angle (ITA) as determined by a spectrophotometer to demonstrate that the sensor technology under test can be accurate across diverse user populations.
The primary hypothesis is that the Owlet OSS 3.0 Sensor will measure SpO2 values within +/- 3% ARMS compared to SaO2 measurements.
Each study participant will have a total study exposure time of 48 hours. Each participant will be assigned to a unique Owlet device with a specific serial number which will be paired with the study subject identifier. The Owlet OSS 3.0 Sensor will be attached to a study subject's foot and SpO2 readings will be acquired at a set frequency and time-aligned with arterial blood gas sampling performed during the course of routine patient care. Study operators will be blinded to Owlet device readings. Time stamping of Owlet SpO2 readings will be achieved by a prescribed tapping of the device's Base Station which will mark the point at which readings simultaneous to the blood gas sample were recorded. SpO2 readings from the available noninvasive reference pulse oximeter will also be recorded during the time of blood gas sampling to document the subject's baseline SpO2 plateau.
- Conditions
- Pulse Oximeter Validation
- Being tested
- Owlet pulse oximeter neonatal accuracy validation
- Keywords
- Pulse oximetry, Neonates, Owlet, Accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Owlet pulse oximeter neonatal accuracy validationDevice
This study specifically evaluates the Owlet pulse oximetry sensor, which is specifically designed and FDA cleared for for infants, and whose accuracy is specifically being validated in the neonate population.
| Study group | Role | What they receive |
|---|---|---|
| Owlet Arm | Experimental | All study participants meeting inclusion criteria with no stated exclusions will wear the Owlet OSS 3.0 Sensor during the study intervention. The Owlet OSS 3.0 Sensor may be placed continuously on a study subject for up to 48 hours with rotation to the opposite foot every 8 hours per device labeling to enable noninvasive data collection during the subject's standard of care blood draws. The Owlet base station will be activated in order to transmit readings but will not provide any external alarms or live displays during the monitoring period. No display of readings from the assigned Owlet device will be made available to the participant or the investigators during the time of data acquisition. Receives: Device: Owlet pulse oximeter neonatal accuracy validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse oximetry Accuracy - Root Mean Square
Accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements from arterial blood gas samples as determined by a root mean square (ARMS) calculation.
Measured: 48 hours
Secondary outcomes (2)
Pulse oximetry Accuracy - Bias
Bias in the Owlet OSS 3.0 Sensor SpO2 vs SaO2 defined as (Owlet OSS 3.0 Sensor SpO2 - SaO2).
Measured: 48 hours
Pulse oximetry Accuracy - Precision
Precision of the Owlet OSS 3.0 Sensor SpO2 vs SaO2 defined as ABS (Owlet OSS 3.0 Sensor SpO2 - SaO2).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulse Oximeter ValidationStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Owlet Baby Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's of Alabama, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Gwenyth Fischer, M.D., Principal investigator, University of Minnesota Medical CenterMichael A Brock, M.D., Principal investigator, University of Alabama Birmingham - Children's of Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771206
- Sponsor's protocol ID
- OWL PR0007
- Status last verified
- Aug 2025
- First submitted
- 7 Jan 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
Publications
Okunlola 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 33326721Wackernagel D, Blennow M, Hellstrom A. Accuracy of pulse oximetry in preterm and term infants is insufficient to determine arterial oxygen saturation and tension. Acta Paediatr. 2020 Nov;109(11):2251-2257. doi: 10.1111/apa.15225. Epub 2020 Mar 6.
PubMed 32043645
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
- Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
- ClinicalTrials.gov ID
- NCT06771206
- Acronym / sponsor ID
- OWL PR0007
- Conditions
- Pulse Oximeter Validation
- Keywords
- Pulse oximetry, Neonates, Owlet, Accuracy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Owlet Baby Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Children's of Alabama, University of Minnesota
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Jan 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.
The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date.
The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.
Detailed description
This is a prospective, non-randomized, single arm study to evaluate SpO2 performance of the Owlet OSS 3.0 pulse oximetry Sensor in the neonate population up to 44 weeks corrected gestational age using convenience sampling of arterial blood gas samples as a part of routine clinical monitoring.
The Owlet OSS 3.0 Sensor is the component of the Owlet Dream Sock (DEN220091) and BabySat (K222597), both Food and Drug Administration (FDA) cleared pulse oximeters for infants 1-18 months in 2023. This component performs the signal acquisition and analysis to estimate pulse rate and SpO2 readings.
The study will enroll between 20-100 neonates weighing a minimum of 1500g in the hospital setting with available arterial line access and arterial blood gas samples being performed as part of planned patient management. No additional blood gas samples will be taken beyond clinical care indications.
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 from arterial blood gas samples as determined by a root mean square (ARMS) calculation.
Secondary outcomes will include:
- Bias in the Owlet OSS 3.0 Sensor SpO2 vs SaO2 defined as (Owlet OSS 3.0 Sensor SpO2 - SaO2).
- Precision of the Owlet OSS 3.0 Sensor SpO2 vs SaO2 defined as ABS (Owlet OSS 3.0 Sensor SpO2 - SaO2).
Accuracy will be stratified by a number of demographic elements, including by a 10 point skin tone scale and Individual Typology Angle (ITA) as determined by a spectrophotometer to demonstrate that the sensor technology under test can be accurate across diverse user populations.
The primary hypothesis is that the Owlet OSS 3.0 Sensor will measure SpO2 values within +/- 3% ARMS compared to SaO2 measurements.
Each study participant will have a total study exposure time of 48 hours. Each participant will be assigned to a unique Owlet device with a specific serial number which will be paired with the study subject identifier. The Owlet OSS 3.0 Sensor will be attached to a study subject's foot and SpO2 readings will be acquired at a set frequency and time-aligned with arterial blood gas sampling performed during the course of routine patient care. Study operators will be blinded to Owlet device readings. Time stamping of Owlet SpO2 readings will be achieved by a prescribed tapping of the device's Base Station which will mark the point at which readings simultaneous to the blood gas sample were recorded. SpO2 readings from the available noninvasive reference pulse oximeter will also be recorded during the time of blood gas sampling to document the subject's baseline SpO2 plateau.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Owlet Arm | Experimental | Device: Owlet pulse oximeter neonatal accuracy validationAll study participants meeting inclusion criteria with no stated exclusions will wear the Owlet OSS 3.0 Sensor during the study intervention. The Owlet OSS 3.0 Sensor may be placed continuously on a study subject for up to 48 hours with rotation to the opposite foot every 8 hours per device labeling to enable noninvasive data collection during the subject's standard of care blood draws. The Owlet base station will be activated in order to transmit readings but will not provide any external alarms or live displays during the monitoring period. No display of readings from the assigned Owlet device will be made available to the participant or the investigators during the time of data acquisition. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Less than or equal to 44 weeks corrected gestational age
- Weight equal or greater than 1500g
- Subjects with standard of care (SOC) arterial blood sampling line already in place at time of enrollment, with anticipated arterial blood gas measurements as part of their plan of care
Key exclusion criteria (6 listed)
- Subjects with underdeveloped skin as assessed by a study investigator and/or reported by the clinical care team
- Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements
- Potential subjects on extracorporeal membrane oxygenation (ECMO) or other mechanical circulatory support
- Arterial line is placed in a preductal position with the potential of pulmonary to systemic shunting
- Subjects undergoing cooling protocol/therapeutic hypothermia
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 |
|---|---|---|
| Owlet pulse oximeter neonatal accuracy validationThis study specifically evaluates the Owlet pulse oximetry sensor, which is specifically designed and FDA cleared for for infants, and whose accuracy is specifically being validated in the neonate population. | Device | Owlet Arm |
Primary outcome
Pulse oximetry Accuracy - Root Mean Square
Time frame: 48 hours
Accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements from arterial blood gas samples as determined by a root mean square (ARMS) calculation.
2 secondary outcomes
Pulse oximetry Accuracy - Bias
Time frame: 48 hours
Pulse oximetry Accuracy - Precision
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- 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.
- Background: PubMed 32043645Wackernagel D, Blennow M, Hellstrom A. Accuracy of pulse oximetry in preterm and term infants is insufficient to determine arterial oxygen saturation and tension. Acta Paediatr. 2020 Nov;109(11):2251-2257. doi: 10.1111/apa.15225. Epub 2020 Mar 6.
- Individual participant dataSharing planned: Undecided
Related trials for Pulse Oximeter Validation
RecruitingObservational study
PRecision Integrated Saturation Monitor
CHD - Congenital Heart Disease, Single Ventricle Heart Disease
Recruiting
Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch
Vital Signs
RecruitingObservational study
Controlled Desaturation Study for Perin Health Patch Validation
Oxygen Saturation Measurement
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.
Guy Alvarez, PhD contact
Gwenyth Fischer, M.D. principal investigator
University of Minnesota Medical Center
Michael A Brock, M.D. principal investigator
University of Alabama Birmingham - Children's of Alabama
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Owlet pulse oximeter neonatal accuracy validation in people with Pulse Oximeter Validation, run by Owlet Baby Care, Inc. at 2 sites 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 6 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: looking for participants now, 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisa L Niksch, M.D. ((844) 334-5330, clinical@owletcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse oximetry Accuracy - Root Mean Square (time frame: 48 hours). 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 NCT06771206, which also lists 3 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.