Recruiting

Owlet OSS 3.0-M1 Sensor

Sponsor:

Owlet Baby Care, Inc.

Code:

NCT07321938

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Accepted

Interventions

Application and monitoring with an Owlet OSS 3.0-M1 Sensor

Reference Pulse Oximeter

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT07321938

Start date

Dec 15, 2025

Status verified date

Jan, 2026

Completion date

Apr 28, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: 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.

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Owlet OSS 3.0-M1 Sensor

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

Interventions

Application and monitoring with an Owlet OSS 3.0-M1 Sensor

Owlet OSS 3.0-M1 Sensor

Reference Pulse Oximeter

Application and monitoring with an FDA cleared reference pulse oximeter

Primary outcome measure

  • Pulse rate accuracy [ Time Frame: 2 hours ]
  • SpO2 Accuracy [ Time Frame: 2 hours ]

Central Contacts and Locations

Locations

Vital Signs Research Group, LLC

Recruiting

San Francisco, California, United States, 94107

Contacts

More Information

Sponsor

Owlet Baby Care, Inc.

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • pulse oximetry
  • pediatrics
  • Owlet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Owlet Baby Care, Inc. on 2026-01-07.