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NCT07321938NARecruitingAccepts Healthy Volunteers

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

Owlet Baby Care, Inc.

Start Date

12/15/2025

Completion Date

4/28/2026

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

DEVICE

Application and monitoring with an Owlet OSS 3.0-M1 Sensor

DEVICE

Reference Pulse Oximeter

Interested in This Trial?

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Conditions

Healthy

Locations

Vital Signs Research Group, LLC

San Francisco, California 94107

United States