Application and monitoring with an Owlet OSS 3.0-M1 SensorReference Pulse Oximeter
Application and monitoring with an Owlet OSS 3.0-M1 Sensor: Owlet OSS 3.0-M1 Sensor
Reference Pulse Oximeter: Application and monitoring with an FDA cleared reference pulse oximeter
Study 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.
Eligibility
Sex
ALL
Min age
19 Months
Max age
60 Months
Healthy volunteers
Accepted
Inclusion Criteria:
1. Subject is between 19 months and ≤ 60 months of age.
2. Subject's current body weight is ≥ 6 lbs.
3. Subject/legal guardian is fluent in both written and spoken English.
4. Subject is willing and able to follow study requirements
5. Legal guardian has provided consent.
Exclusion Criteria:
1. Subject has preexisting cardiovascular or respiratory disease or conditions.
2. Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements.
3. 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).
4. Subject has skin irritation at the location of device placement.
5. Subject has known allergies to adhesive.
Primary outcome measure(s)
Pulse rate accuracy — 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 — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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