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NCT03630016 · ClinicalTrials.gov registry record · NA
SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
A NA study, sponsored by Owlet Baby Care.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT03630016: Completed NA study, sponsored by Owlet Baby Care.
NCT03630016 is a NA study that has completed, run by Owlet Baby Care. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03630016, a NA study, has completed, sponsored by Owlet Baby Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study 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.
Primary Outcome
The purpose of the study was to evaluate the accuracy of the blood oxygen saturation (SpO2) at rest over the range of 70-100% compared to arterial blood samples assessed by standard methods \[Co-Oximetry\]. A standard pulse oximeter accuracy is evaluated by the Accuracy Root Mean Square (ARMS). The results of accurate performance of the oximetry system require ARMS of 3% or less in non-motion conditions for the range of 70-100% SpO2 per standard.
Interventions
- DIAGNOSTIC_TEST Pulse oximetry with Owlet BabySat v1.0 sensor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-12-13 |
| Est. Completion | 2017-12-17 |
| Phase | NA |
What the finished NCT03630016 record still lists
NCT03630016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Pulse oximetry with Owlet BabySat v1.0 sensor is the first listed.
NCT03630016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03630016 about?
NCT03630016 is a clinical study titled "SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry". 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 ...
What is the current status of trial NCT03630016?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2017-12-13. Estimated completion is 2017-12-17.
What interventions are being tested in trial NCT03630016?
The interventions under investigation include: Pulse oximetry with Owlet BabySat v1.0 sensor (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03630016?
This trial is sponsored by Owlet Baby Care, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03630016's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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