NCT07321938NARecruitingAccepts Healthy Volunteers
Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
Owlet Baby Care, Inc.
Start Date
12/15/2025
Completion Date
4/28/2026
Summary
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.
Eligibility Criteria
Age Range: No minimum to No maximum
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.
Interventions
DEVICE
Application and monitoring with an Owlet OSS 3.0-M1 Sensor
DEVICE
Reference Pulse Oximeter
Conditions
Healthy
Locations
Vital Signs Research Group, LLC
San Francisco, California 94107
United States