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

Owlet

Status

Enrolling

Conditions

Healthy

Treatments

Device: Reference Pulse Oximeter

Device: Application and monitoring with an Owlet OSS 3.0-M1 Sensor

Study type

Interventional

Funder types

Industry

Identifiers

NCT07321938

OWL-TOP-2501

Details and patient eligibility

About

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

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

19 to 60 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is between 19 months and ≤ 60 months of age.
Subject's current body weight is ≥ 6 lbs.
Subject/legal guardian is fluent in both written and spoken English.
Subject is willing and able to follow study requirements
Legal guardian has provided consent.

Exclusion criteria

Subject has preexisting cardiovascular or respiratory disease or conditions.
Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements.
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).
Subject has skin irritation at the location of device placement.
Subject has known allergies to adhesive.