Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers (TOPS)

January 6, 2026 updated by: Owlet Baby Care, Inc.
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to collect evidence to verify the accuracy of the Owlet OSS 3.0-M1 Sensor to measure SpO2 and pulse rate in children 19-60 months in a simulated use environment as compared to an FDA cleared reference pulse oximeter.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Owlet OSS 3.0-M1 Sensor
Owlet OSS 3.0-M1 Sensor accuracy evaluation compared to a reference pulse oximeter.
Device: Application and monitoring with an Owlet OSS 3.0-M1 Sensor
Owlet OSS 3.0-M1 Sensor
Device: Reference Pulse Oximeter
Application and monitoring with an FDA cleared reference pulse oximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse rate accuracy
Time Frame: 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
2 hours
SpO2 Accuracy
Time Frame: 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.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Owlet Baby Care, Inc.

Investigators

  • Principal Investigator: Greg Stratmann, MD, PhD, Vital Signs Research Group, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

April 28, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OWL-TOP-2501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data collected during the course of this study are specifically intended for a regulatory submission and may or may not be shared publicly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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