NCT07321938

Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Owlet Baby Care, Inc. · Industry
• Sex: All
• Age: 19 Months – 60 Months
• Healthy volunteers: Accepted

Summary

The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.

Detailed description

The objective of this study is to collect evidence to verify the accuracy of the Owlet OSS 3.0-M1 Sensor to measure SpO2 and pulse rate in children 19-60 months in a simulated use environment as compared to an FDA cleared reference pulse oximeter.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Application and monitoring with an Owlet OSS 3.0-M1 Sensor	Owlet OSS 3.0-M1 Sensor
DEVICE	Reference Pulse Oximeter	Application and monitoring with an FDA cleared reference pulse oximeter

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-03-31
• Completion: 2026-04-28
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study