Owlet Smart Sock 3 Accuracy on Infants

NCT05635513 | Completed

• 1 other identifier: OWL NICU 07-2021
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a standard wired pulse oximeter simultaneously. The monitoring duration with the study device will be a maximum of 60 minutes, after which the recorded data from the Owlet Smart Sock 3 and the standard wired pulse oximeters will be de-identified and analyzed.

Conditions

Hypoxia Neonatal

Outcome Measures

Primary Outcomes (2)

• Owlet Oxygen Saturation Accuracy Performance

  Conduct a single-arm observational study to monitor oxygen saturation (SpO2) while a standard wired pulse oximeter (WPOx) will simultaneously evaluate the same parameters in the University of Utah (U of U) Neonatal Intensive Care Unit (NICU).

  During the monitoring period (approx. 1 hour)

• Owlet Pulse Rate Accuracy Performance

  Conduct a single-arm observational study to monitor heart rate (HR), while a standard wired pulse oximeter (WPOx) will simultaneously evaluate the same parameters in the University of Utah (U of U) Neonatal Intensive Care Unit (NICU).

  During the monitoring period (approx. 1 hour)

Interventions

Owlet OSS V3 DEVICE

A wearable pulse oximeter designed for monitoring infants and children in a home environment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infants admitted to the University of Utah NICU that weigh between 1.7kg and 2.3kg and do not meet exclusion criteria.

You may qualify if:

• Infant who weigh between 1.7kg and 2.3kg
• Infant who is admitted to U of U NICU

You may not qualify if:

• Infant who has injuries, deformities, abnormalities, or intravenous catheter in the extremities that may prevent proper application of device
• Infant who has unstable vital signs or clinical condition
• No parental consent
• Inability to achieve adequate fit with the OSS3

Sponsors & Collaborators

• Owlet Baby Care, Inc.: lead

Study Sites (1)

University of Utah NICU

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Belinda Chan, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: July 14, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: February 22, 2023

Record last verified: 2022-12

Locations

US (1)