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?
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
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
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