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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus

NCT06850610

Hypoxia

COMPLETED NA

Owlet Smart Sock 3 Accuracy on Infants

NCT05635513

Hypoxia Neonatal

COMPLETED

Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)

NCT03125018

Healthy

COMPLETED NA

Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia

NCT04446247

Hypoxia

COMPLETED

Accuracy of BabySat V3 With Profound Hypoxia and Motion

NCT05581394

Hypoxia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Owlet OSS 3.0-M1 Sensor

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

Group Type EXPERIMENTAL

Application and monitoring with an Owlet OSS 3.0-M1 Sensor

Intervention Type DEVICE

Owlet OSS 3.0-M1 Sensor

Reference Pulse Oximeter

Intervention Type DEVICE

Application and monitoring with an FDA cleared reference pulse oximeter

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Application and monitoring with an Owlet OSS 3.0-M1 Sensor

Owlet OSS 3.0-M1 Sensor

Intervention Type DEVICE

Reference Pulse Oximeter

Application and monitoring with an FDA cleared reference pulse oximeter

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

19 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes