N/A
N=11
SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT03630016 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100% — 2.4 Percent SpO2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pulse oximetry with Owlet BabySat v1.0 sensor (Diagnostic_test)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Owlet Baby Care, Inc.
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100% |
2.4 | — |
Summary
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.
Eligibility Criteria
Inclusion Criteria
- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance, made up of either.
- Subject must have the ability to understand and provide written informed consent
- Subject is 18 to 50 years of age
- At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who have not smoked within 2 days prior to the study.
Exclusion Criteria
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study
- Females who are pregnant, who are trying to get pregnant
- Smoker Subjects who have refrained will be screened for COHb levels
- Subjects with known heart or cardiovascular conditions
- Subjects with known clotting disorders
Data sourced from ClinicalTrials.gov (NCT03630016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.