Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Application and monitoring with an Owlet OSS 3.0-M1 Sensor, Reference Pulse Oximeter.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 19 months — 60 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Detailed 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.
Interventions
- Device Application and monitoring with an Owlet OSS 3.0-M1 Sensor
Owlet OSS 3.0-M1 Sensor - Device Reference Pulse Oximeter
Application and monitoring with an FDA cleared reference pulse oximeter
Primary outcome measures
- Pulse rate accuracy [Time frame: 2 hours]
- SpO2 Accuracy [Time frame: 2 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Vital Signs Research Group, LLC — San Francisco
Identifiers
NCT: NCT07321938 · OWL-TOP-2501