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

NCT07321938 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Owlet Baby Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Greg Stratmann, MD, PhD · Vital Signs Research Group, LLC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-03-31
Completion
2026-04-28
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07321938 on ClinicalTrials.gov