Recruiting

Owlet OSS 3.0

Sponsor:

Owlet Baby Care, Inc.

Code:

NCT06771206

Conditions

Pulse Oximeter Validation

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Owlet pulse oximeter neonatal accuracy validation

Study Details

Brief 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

Study ID

NCT06771206

Start date

Aug 1, 2025

Status verified date

Aug, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Owlet Arm

All study participants meeting inclusion criteria with no stated exclusions will wear the Owlet OSS 3.0 Sensor during the study intervention. The Owlet OSS 3.0 Sensor may be placed continuously on a study subject for up to 48 hours with rotation to the opposite foot every 8 hours per device labeling to enable noninvasive data collection during the subject's standard of care blood draws. The Owlet base station will be activated in order to transmit readings but will not provide any external alarms or live displays during the monitoring period. No display of readings from the assigned Owlet device will be made available to the participant or the investigators during the time of data acquisition.

Interventions

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.

Primary outcome measure

  • Pulse oximetry Accuracy - Root Mean Square [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Alisa L Niksch, M.D.

(844) 334-5330clinical@owletcare.com

Guy Alvarez, PhD

galvarez@owletcare.com

Locations

University of Alabama Birmingham - Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Kristal Hock, MSN

(205) 996-3313KristalHock@uabmc.edu

Principal Investigator:

Michael A Brock, M.D.

University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Amy Kodet, MPP

(612) 625-6678kodet006@umn.edu

Principal Investigator:

Gwenyth Fischer, M.D.

More Information

Sponsor

Owlet Baby Care, Inc.

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

  • Pulse oximetry
  • Neonates
  • Owlet
  • Accuracy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Owlet Baby Care, Inc. on 2025-08-14.