RecruitingNot ApplicableNCT07321938
Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
Sponsor
Owlet Baby Care, Inc.
Enrollment
90 participants
Start Date
Dec 15, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 19 MonthsMax Age: 60 Months
Inclusion Criteria5
- 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.
Exclusion Criteria5
- 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.
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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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07321938
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