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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07321938

Acronym

TOPS

Enrollment

Registered

2026-01-07

Start date

2025-12-15

Completion date

2026-04-28

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pulse oximetry, pediatrics, Owlet

Brief summary

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

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.

Interventions

DEVICEApplication and monitoring with an Owlet OSS 3.0-M1 Sensor

Owlet OSS 3.0-M1 Sensor

DEVICEReference Pulse Oximeter

Application and monitoring with an FDA cleared reference pulse oximeter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Prospective study

Eligibility

Sex/Gender

ALL

Age

19 Months to 60 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Pulse rate accuracy	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
SpO2 Accuracy	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026