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Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
RecruitingHealthy volunteers welcome
Who can join
19 Months – 60 Months · All sexes · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
What is being tested
- Application and monitoring with an Owlet OSS 3.0-M1 Sensor (device)
- Reference Pulse Oximeter (device)
Sponsor: Owlet Baby Care, Inc. · Participants: 90 · Started: Dec 15, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT07321938
Locations in the U.S.
| California | Vital Signs Research Group, LLC, San Francisco |
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.