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

Part of paid clinical trials in San Francisco, California.

Sponsor
Owlet Baby Care, Inc.
Study ID
NCT07321938
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
19 Months - 60 Months
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 15, 2025
Status verified
Jan 2026
Primary completion
Mar 31, 2026
Completion
Apr 28, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Owlet OSS 3.0-M1 Sensor
    Owlet OSS 3.0-M1 Sensor accuracy evaluation compared to a reference pulse oximeter.

Primary Outcome Measure

Pulse rate accuracy [ Time Frame: 2 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vital Signs Research Group, LLCSan FranciscoCalifornia94107
Koa Gudelunas, PhD
[email protected]
650-868-5155

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By research site
Vital Signs Research Group, LLC· San Francisco, CA

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