Owlet Sensor Accuracy for Healthy Toddlers and Preschoolers
(TOPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the accuracy of the Owlet OSS 3.0-M1 Sensor, a device for measuring vital signs in toddlers and preschoolers. The study compares the sensor's readings to those of a standard pulse oximeter, which measures blood oxygen levels. It seeks healthy children between 19 and 60 months old who do not have heart or lung diseases and whose parents can communicate in English. Children with skin irritation or limb deformities where the device is placed would not be suitable for this study. As an unphased study, this trial offers an opportunity to contribute to the development of innovative health monitoring technology for young children.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that the Owlet OSS 3.0-M1 Sensor is safe for toddlers and preschoolers?
Research has shown that the Owlet OSS 3.0-M1 Sensor is generally safe and comfortable for measuring oxygen levels and pulse rates in young children. This sensor is often compared to standard pulse oximeters, which are widely used and considered safe. Although the FDA once issued a warning about some infant monitors, it did not specifically target the Owlet OSS 3.0-M1 Sensor under study. This suggests that the sensor is expected to be safe, particularly because it does not involve medication or invasive procedures.12345
Why are researchers excited about this trial?
Researchers are excited about the Owlet OSS 3.0-M1 Sensor because it offers a non-invasive way to monitor the oxygen levels in toddlers and preschoolers. Unlike traditional pulse oximeters that can be bulky and uncomfortable for young children, this sensor is designed to be lightweight and easy to wear, potentially increasing comfort and compliance. Plus, it aims to deliver accurate readings comparable to standard devices, which could make it a game-changer for consistent and reliable home health monitoring.
What evidence suggests that the Owlet OSS 3.0-M1 Sensor is effective for evaluating accuracy in toddlers and preschoolers?
Research has shown that the Owlet OSS 3.0-M1 Sensor is being tested in this trial to assess its effectiveness in monitoring vital signs, such as oxygen levels, in young children. The trial will compare the sensor's accuracy in measuring blood oxygen levels (SpO2) to that of a standard pulse oximeter, a device known for its reliability. Previous tests of similar Owlet sensors demonstrated a sensitivity of 88.8% and a specificity of 85.7% in correctly identifying low blood oxygen levels. These results suggest that the Owlet sensor could effectively monitor vital signs in toddlers and preschoolers.12456
Who Is on the Research Team?
Greg Stratmann, MD, PhD
Principal Investigator
Vital Signs Research Group, LLC
Are You a Good Fit for This Trial?
This trial is for healthy toddlers and preschoolers aged between 19 months and 5 years, weighing at least 6 pounds. They must have a guardian who can understand and speak English well, agree to the study's requirements, and provide consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Evaluation
Participants undergo sensor accuracy evaluation using the Owlet OSS 3.0-M1 Sensor compared to a reference pulse oximeter
Follow-up
Participants are monitored for any immediate post-evaluation effects and data analysis
What Are the Treatments Tested in This Trial?
Interventions
- Owlet OSS 3.0-M1 Sensor
Trial Overview
The trial is testing the Owlet OSS 3.0-M1 Sensor's accuracy in monitoring vital signs like oxygen levels in young children compared to a standard pulse oximeter used in medical settings.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Owlet OSS 3.0-M1 Sensor accuracy evaluation compared to a reference pulse oximeter.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Owlet Baby Care, Inc.
Lead Sponsor
Citations
Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in ...
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
Owlet Sensor Accuracy for Healthy Toddlers and ...
The trial is testing the Owlet OSS 3.0-M1 Sensor's accuracy in monitoring vital signs like oxygen levels in young children compared to a standard pulse oximeter ...
3.
ctv.veeva.com
ctv.veeva.com/study/evaluation-of-accuracy-of-the-owlet-oss-30-sensor-in-the-neonatal-populationEvaluation of Accuracy of the Owlet OSS 3.0 Sensor in the ...
The primary outcome of the study is the accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) ...
Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in ...
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 ...
The Owlet Smart Sock—a “must have” for the baby registry?
The authors reported that the sensitivity and specificity of the Owlet for hypoxemia was 88.8% and 85.7%, respectively, and for bradycardia was 0.0% and 100.0%, ...
6.
owletcare.com
owletcare.com/blogs/all/owlet-response-to-fda-safety-communication?srsltid=AfmBOopoH-peD8Pan5L8jTNqROc2BsDVFWjLXt6KosT0JTDgBDQfpnKoOwlet® Response to FDA Safety Communication
On September 16, 2025, the FDA issued an official safety communication cautioning families against the use of unauthorized infant monitors ...
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