Owlet OSS 3.0-M1 sensor accuracy for oxygen level and pulse in toddlers and preschoolers
Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
We will test whether the Owlet OSS 3.0-M1 wearable sensor accurately measures blood oxygen (SpO2) and pulse rate in children 19 to 60 months old.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 19 Months to 60 Months |
| Sex | All |
| Sponsor | Owlet Baby Care, Inc. Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07321938 on ClinicalTrials.gov |
What this trial studies
This interventional study collects readings from the Owlet OSS 3.0-M1 Sensor applied to children aged 19 to 60 months in a simulated use environment and compares them to measurements from an FDA-cleared reference pulse oximeter. Participants who meet inclusion criteria will have the Owlet device placed at planned application sites while concurrent reference measurements are recorded. Children with conditions or skin issues that would interfere with device placement are excluded to ensure measurement validity. The main goal is to determine agreement between the consumer sensor and the clinical reference across the target age range.
Who should consider this trial
Good fit: Healthy children aged 19 to 60 months who weigh at least 6 pounds, whose legal guardian can consent and follow instructions, and who have no cardiovascular/respiratory disease or skin issues at the device site are ideal candidates.
Not a fit: Children with preexisting heart or lung disease, skin irritation or wounds at the placement site, poor device fit, or known adhesive allergies are unlikely to benefit from this accuracy testing.
Why it matters
Potential benefit: If accurate, this device could give caregivers and clinicians more confidence in using the Owlet sensor to monitor SpO2 and pulse in young children at home.
How similar studies have performed: Previous validation work on consumer pulse oximeters and earlier wearable infant monitors has produced mixed results, so direct comparison to an FDA-cleared reference in this age group is needed.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- Vital Signs Research Group, LLC — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Greg Stratmann, MD, PhD — Vital Signs Research Group, LLC
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.