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

NCT06771206 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-14

No results posted yet for this study

Summary

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.

Conditions

  • Pulse Oximeter Validation

Interventions

DEVICE

Owlet pulse oximeter neonatal accuracy validation

This study specifically evaluates the Owlet pulse oximetry sensor, which is specifically designed and FDA cleared for for infants, and whose accuracy is specifically being validated in the neonate population.

Sponsors & Collaborators

  • Children's of Alabama

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Owlet Baby Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Gwenyth Fischer, M.D. · University of Minnesota Medical Center

  • Michael A Brock, M.D. · University of Alabama Birmingham - Children's of Alabama

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-12-31
Completion
2026-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06771206 on ClinicalTrials.gov