90 Participants Needed

Owlet Sensor Accuracy for Healthy Toddlers and Preschoolers

(TOPS Trial)

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Owlet Baby Care, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

GS

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

My current weight is at least 6 pounds.
I am fluent in English, both in writing and speaking.
I am willing and able to follow the study's requirements.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Evaluation

Participants undergo sensor accuracy evaluation using the Owlet OSS 3.0-M1 Sensor compared to a reference pulse oximeter

2 hours
1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-evaluation effects and data analysis

1 week

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

Group I: Owlet OSS 3.0-M1 SensorExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Owlet Baby Care, Inc.

Lead Sponsor

Trials
11
Recruited
9,600+