HealthyTOPSNCT07321938
Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
A study testing Application and monitoring with an Owlet OSS 3.0-M1 Sensor and Reference Pulse Oximeter in people with Healthy, run by Owlet Baby Care, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy. Read more about this study
- Who is it for?
- Ages 19 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Application and monitoring with an Owlet OSS 3.0-M1 Sensor and Reference Pulse Oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 28 Apr 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 19 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject is between 19 months and ≤ 60 months of age.
- Subject's current body weight is ≥ 6 lbs.
- Subject/legal guardian is fluent in both written and spoken English.
- Subject is willing and able to follow study requirements
- Legal guardian has provided consent.
Who cannot join
- Subject has preexisting cardiovascular or respiratory disease or conditions.
- Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements.
- The device(s) are unable to fit properly without risk of injury (e.g., hook of VELCRO is against the skin, wrap is too tight and constricting).
- Subject has skin irritation at the location of device placement.
- Subject has known allergies to adhesive.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vital Signs Research Group, LLC
San Francisco, California, 94107
Koa Gudelunas, PhD, 650-868-5155, koa@vitalsignsresearchgroup.com
About this study
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
Read the detailed description
The objective of this study is to collect evidence to verify the accuracy of the Owlet OSS 3.0-M1 Sensor to measure SpO2 and pulse rate in children 19-60 months in a simulated use environment as compared to an FDA cleared reference pulse oximeter.
- Conditions
- Healthy
- Being tested
- Application and monitoring with an Owlet OSS 3.0-M1 Sensor, Reference Pulse Oximeter
- Keywords
- pulse oximetry, pediatrics, Owlet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application and monitoring with an Owlet OSS 3.0-M1 SensorDevice
Owlet OSS 3.0-M1 Sensor
Reference Pulse OximeterDevice
Application and monitoring with an FDA cleared reference pulse oximeter
| Study group | Role | What they receive |
|---|---|---|
| Owlet OSS 3.0-M1 Sensor | Experimental | Owlet OSS 3.0-M1 Sensor accuracy evaluation compared to a reference pulse oximeter. Receives: Device: Application and monitoring with an Owlet OSS 3.0-M1 Sensor; Device: Reference Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse rate accuracy
Average root mean square (ARMS) error between the pulse rate measured by the Owlet OSS 3.0-M1 vs. a reference pulse oximeter
Measured: 2 hours
SpO2 Accuracy
The average root mean square difference between the Owlet OSS 3.0-M1 Sensor vs. readints from an FDA cleared reference pulse oximeter.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Dec 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion28 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Prospective study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Owlet Baby Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greg Stratmann, MD, PhD, Principal investigator, Vital Signs Research Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321938
- Sponsor's protocol ID
- OWL-TOP-2501
- Acronym
- TOPS
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
- ClinicalTrials.gov ID
- NCT07321938
- Acronym / sponsor ID
- TOPS / OWL-TOP-2501
- Conditions
- Healthy
- Keywords
- pulse oximetry, pediatrics, Owlet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Owlet Baby Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 28 Apr 2026 (estimated)
- First posted
- 7 Jan 2026 (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 purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
Detailed description
The objective of this study is to collect evidence to verify the accuracy of the Owlet OSS 3.0-M1 Sensor to measure SpO2 and pulse rate in children 19-60 months in a simulated use environment as compared to an FDA cleared reference pulse oximeter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective study
| Arm | Type | Receives |
|---|---|---|
| Owlet OSS 3.0-M1 Sensor | Experimental | Device: Application and monitoring with an Owlet OSS 3.0-M1 Sensor, Device: Reference Pulse OximeterOwlet OSS 3.0-M1 Sensor accuracy evaluation compared to a reference pulse oximeter. |
Who may qualify
- Ages
- 19 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subject is between 19 months and ≤ 60 months of age.
- Subject's current body weight is ≥ 6 lbs.
- Subject/legal guardian is fluent in both written and spoken English.
- Subject is willing and able to follow study requirements
- Legal guardian has provided consent.
Key exclusion criteria (5 listed)
- Subject has preexisting cardiovascular or respiratory disease or conditions.
- Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements.
- The device(s) are unable to fit properly without risk of injury (e.g., hook of VELCRO is against the skin, wrap is too tight and constricting).
- Subject has skin irritation at the location of device placement.
- Subject has known allergies to adhesive.
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 |
|---|---|---|
| Application and monitoring with an Owlet OSS 3.0-M1 SensorOwlet OSS 3.0-M1 Sensor | Device | Owlet OSS 3.0-M1 Sensor |
| Reference Pulse OximeterApplication and monitoring with an FDA cleared reference pulse oximeter | Device | Owlet OSS 3.0-M1 Sensor |
Primary outcome
Pulse rate accuracy
Time frame: 2 hours
Average root mean square (ARMS) error between the pulse rate measured by the Owlet OSS 3.0-M1 vs. a reference pulse oximeter
SpO2 Accuracy
Time frame: 2 hours
The average root mean square difference between the Owlet OSS 3.0-M1 Sensor vs. readints from an FDA cleared reference pulse oximeter.
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 7 Jan 2026.
- 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.
Vital Signs Research Group, LLC
San Francisco, United States
Greg Stratmann, MD, PhD principal investigator
Vital Signs Research Group, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application and monitoring with an Owlet OSS 3.0-M1 Sensor and Reference Pulse Oximeter in people with Healthy, 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 5 inclusion and 5 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 7 Jan 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse rate accuracy (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.