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

NCT06771206 | Recruiting FDA Device

• 1 other identifier: OWL PR0007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

Pulse oximetry; Neonates; Owlet; Accuracy

Outcome Measures

Primary Outcomes (1)

• Pulse oximetry Accuracy - Root Mean Square

  Accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements from arterial blood gas samples as determined by a root mean square (ARMS) calculation.

  48 hours

Secondary Outcomes (2)

• Pulse oximetry Accuracy - Bias

  48 hours

• Pulse oximetry Accuracy - Precision

  48 hours

Study Arms (1)

Owlet Arm

EXPERIMENTAL

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.

Device: Owlet pulse oximeter neonatal accuracy validation

Interventions

Owlet pulse oximeter neonatal accuracy validation DEVICE

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.

Owlet Arm

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Owlet Baby Care, Inc.: lead
• Children's of Alabama: collaborator
• University of Minnesota: collaborator

Study Sites (2)

University of Alabama Birmingham - Children's of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

University of Minnesota Medical Center

Minneapolis, Minnesota, 55454, United States

RECRUITING

Related Publications (3)

• Okunlola OE, Lipnick MS, Batchelder PB, Bernstein M, Feiner JR, Bickler PE. Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Respir Care. 2022 Feb;67(2):252-257. doi: 10.4187/respcare.09795. Epub 2021 Nov 12.

  PMID: 34772785 BACKGROUND

• Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056/NEJMc2029240. No abstract available.

  PMID: 33326721 BACKGROUND

• Wackernagel D, Blennow M, Hellstrom A. Accuracy of pulse oximetry in preterm and term infants is insufficient to determine arterial oxygen saturation and tension. Acta Paediatr. 2020 Nov;109(11):2251-2257. doi: 10.1111/apa.15225. Epub 2020 Mar 6.

  PMID: 32043645 BACKGROUND

Study Officials

• Gwenyth Fischer, M.D.

  University of Minnesota Medical Center

  PRINCIPAL INVESTIGATOR

• Michael A Brock, M.D.

  University of Alabama Birmingham - Children's of Alabama

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisa L Niksch, M.D.

CONTACT

(844) 334-5330; clinical@owletcare.com

Guy Alvarez, PhD

CONTACT

galvarez@owletcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (2)