Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor
This study is testing how accurately the Owlet OSS 3.0-M1 Sensor measures pulse rate (how fast your heart beats) and SpO2 (the amount of oxygen in your blood) in healthy toddlers and preschoolers. We are comparing its readings to those from a standard, FDA-approved pulse oximeter. We are looking for children between 19 months and 5 years old who weigh at least 6 pounds and whose legal guardian speaks and writes English. The goal is to see if the Owlet sensor provides accurate measurements. The study is currently unclear on its recruitment status and plans to enroll 90 participants.
- Study design
- This interventional study plans to enroll 90 healthy toddlers and preschoolers. It involves applying both the Owlet OSS 3.0-M1 Sensor and a reference pulse oximeter.
- What's involved
- You would have the Owlet OSS 3.0-M1 Sensor and a reference pulse oximeter applied and monitored for 2 hours.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurements for pulse rate and SpO2 accuracy are taken at 2 hours.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Greg Stratmann, MD, PhD · PRINCIPAL_INVESTIGATOR · Vital Signs Research Group, LLC
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Pulse rate accuracy2 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 Accuracy2 hours
The average root mean square difference between the Owlet OSS 3.0-M1 Sensor vs. readints from an FDA cleared reference pulse oximeter.