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Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus

NCT06850610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2025-08-14

No results posted yet for this study

Summary

This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test pulse oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen saturations. The arterial blood sample is processed in a device called a multi-wavelength hemoximeter and compared to the simultaneous oximeter reading. During each set level of oxygen the participant may be asked to have a motion simulator device apply different types of movement to their hands to assess the pulse oximeter's accuracy during motion. This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age.

Testing should require approximately an hour and 15 minutes of the participant's time.

Conditions

Interventions

DIAGNOSTIC_TEST

Pulse oximeter accuracy under hypoxic conditions

This study will specifically evaluate the accuracy of the Owlet pulse oximeter sensor, currently FDA cleared for infants 1-18 months of age in an expanded hypoxia lab trial.

Sponsors & Collaborators

  • Owlet Baby Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Koa Gudelunas · Vital Signs Research Group

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2025-08-06
Completion
2025-08-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06850610 on ClinicalTrials.gov