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

RecruitingNAAges 19 Months - 60 MonthsAllOwlet Baby Care, Inc.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Subject is between 19 months and โ‰ค 60 months of age. 2. Subject's current body weight is โ‰ฅ 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.
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What it tests

  • Application and monitoring with an Owlet OSS 3.0-M1 Sensor
  • Reference Pulse Oximeter
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Where

1 site
Vital Signs Research Group, LLC
San Francisco, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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