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

Owlet Baby Care, Inc. · NCT07321938

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 1–5 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
90
US sites recruiting
1
Study start
December 15, 2025
Record last updated
January 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Application and monitoring with an Owlet OSS 3.0-M1 Sensor; Reference Pulse Oximeter

Conditions: Healthy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 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.

Recruiting US locations

  • Vital Signs Research Group, LLC

    San Francisco, CA 94107

    Site contact: Koa Gudelunas, PhD · 650-868-5155 · koa@vitalsignsresearchgroup.com

All healthy volunteers studies in California →
Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and… (NCT07321938) | Bored Studies