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NCT04446247 · ClinicalTrials.gov registry record
Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia
A clinical trial of Hypoxia, sponsored by Owlet Baby Care.
- Completed
- Registry status
- 14
- Enrollment target
- 1
- Study location
NCT04446247: Completed study of Hypoxia, sponsored by Owlet Baby Care.
NCT04446247 is a study of Hypoxia that has completed, run by Owlet Baby Care. The registered enrollment target is 14 participants, below the 3,117-participant average among 39 other Hypoxia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04446247, a study of Hypoxia, has completed, sponsored by Owlet Baby Care.
- COMPLETED
- Registry status
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
Primary Outcome
Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Owlet Smart Sock Sensor 3rd Generation
Study Locations (1)
California
- University California San Fransisco, Department of Anesthesia - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-03-12 |
| Est. Completion | 2020-03-13 |
What the finished NCT04446247 record still lists
NCT04446247 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 3,117-participant average among 39 other Hypoxia trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Hypoxia appearing as the primary indexed condition, and to 1 intervention - of which Owlet Smart Sock Sensor 3rd Generation is the first listed.
NCT04446247 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04446247 about?
NCT04446247 is a clinical study titled "Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia". Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This ...
What is the current status of trial NCT04446247?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2020-03-12. Estimated completion is 2020-03-13.
What conditions does trial NCT04446247 study?
This clinical trial studies the following conditions: Hypoxia.
What interventions are being tested in trial NCT04446247?
The interventions under investigation include: Owlet Smart Sock Sensor 3rd Generation (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04446247?
This trial is sponsored by Owlet Baby Care, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04446247 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04446247's enrollment target sits among peer trials
14 28th of 39 higher than 12 of 39 other Hypoxia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoxia 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.
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