🏛️ Verified NIH Record • Updated 2026-01-06
Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers (NCT07321938)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Owlet Baby Care, Inc.
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (6 items).
Location: Vital Signs Research Group, LLC — San Francisco, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Vital Signs Research Group, LLC — San Francisco, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.