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

N/ARecruitingNCT07321938

Owlet Baby Care, Inc.90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Application and monitoring with an Owlet OSS 3.0-M1 SensorDEVICE

Owlet OSS 3.0-M1 Sensor

Reference Pulse OximeterDEVICE

Application and monitoring with an FDA cleared reference pulse oximeter

Eligibility

Sex: ALLMin age: 19 MonthsMax age: 60 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is between 19 months and ≤ 60 months of age. 2. Subject's current body weight is ≥ 6 lbs. 3. Subject/legal guardian is fluent in both written and spoken English. 4. Subject is willing and able to follow study requirements 5. Legal guardian has provided consent. Exclusion Criteria: 1. Subject has preexisting cardiovascular or respiratory disease or conditions. 2. Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements. 3. The device(s) are unable to fit properly without risk of injury (e.g., hook of VELCRO is against the skin, wrap is too tight and constricting). 4. Subject has skin irritation at the location of device placement. 5. Subject has known allergies to adhesive.

Locations (1)

Vital Signs Research Group, LLC

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Pulse rate accuracy

Average root mean square (ARMS) error between the pulse rate measured by the Owlet OSS 3.0-M1 vs. a reference pulse oximeter

Time frame: 2 hours

SpO2 Accuracy

The average root mean square difference between the Owlet OSS 3.0-M1 Sensor vs. readints from an FDA cleared reference pulse oximeter.

Time frame: 2 hours

Data from ClinicalTrials.gov

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