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

Recruiting now · Not applicable

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT07321938

Run by

Owlet Baby Care, Inc.

People needed

90

Starts

2025-12-15

Expected to finish

2026-04-28

Last updated by the study team

2026-01-07

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is between 19 months and ≤ 60 months of age.
• Subject's current body weight is ≥ 6 lbs.
• Subject/legal guardian is fluent in both written and spoken English.
• Subject is willing and able to follow study requirements
• Legal guardian has provided consent.

You may not qualify if…

• Subject has preexisting cardiovascular or respiratory disease or conditions.
• Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements.
• 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).
• Subject has skin irritation at the location of device placement.
• Subject has known allergies to adhesive.

Where it is running

• Vital Signs Research Group, LLC — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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