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Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population

Owlet Baby Care, Inc. · with Children's of Alabama, University of Minnesota · NCT06771206

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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 0 mo–1 mo · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
2
Study start
August 1, 2025
Record last updated
August 14, 2025

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

What the study is about

The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date.

The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.

Being studied: Owlet pulse oximeter neonatal accuracy validation

Conditions: Pulse Oximeter Validation

Eligibility criteria

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

Show full criteria

Inclusion Criteria

  • Less than or equal to 44 weeks corrected gestational age
  • Weight equal or greater than 1500g
  • Subjects with standard of care (SOC) arterial blood sampling line already in place at time of enrollment, with anticipated arterial blood gas measurements as part of their plan of care

Exclusion Criteria

  • Subjects with underdeveloped skin as assessed by a study investigator and/or reported by the clinical care team
  • Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements
  • Potential subjects on extracorporeal membrane oxygenation (ECMO) or other mechanical circulatory support
  • Arterial line is placed in a preductal position with the potential of pulmonary to systemic shunting
  • Subjects undergoing cooling protocol/therapeutic hypothermia
  • Subjects who are deemed too clinically unstable by the Principal Investigator (PI), sub-investigator and/or clinical care team to participate in the study.

Recruiting US locations

  • University of Alabama Birmingham - Children's of Alabama

    Birmingham, AL 35233

    Site contact: Kristal Hock, MSN · (205) 996-3313 · KristalHock@uabmc.edu

  • University of Minnesota Medical Center

    Minneapolis, MN 55454

    Site contact: Amy Kodet, MPP · (612) 625-6678 · kodet006@umn.edu

Study contacts (from the official record)

  • Alisa L Niksch, M.D. · (844) 334-5330 · clinical@owletcare.com
  • Guy Alvarez, PhD · galvarez@owletcare.com
Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal… (NCT06771206) | Bored Studies