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NCT05635513 · ClinicalTrials.gov registry record
Owlet Smart Sock 3 Accuracy on Infants
A clinical trial, sponsored by Owlet Baby Care.
- Completed
- Registry status
- 28
- Enrollment target
NCT05635513: Completed study, sponsored by Owlet Baby Care.
NCT05635513 is a clinical trial that has completed, run by Owlet Baby Care. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05635513 has completed, sponsored by Owlet Baby Care.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a standard wired pulse oximeter simultaneously. The monitoring duration with the study device will be a maximum of 60 minutes, after which the recorded data from the Owlet Smart Sock 3 and the standard wired pulse oximeters will be de-identified and analyzed.
Primary Outcome
Conduct a single-arm observational study to monitor oxygen saturation (SpO2) while a standard wired pulse oximeter (WPOx) will simultaneously evaluate the same parameters in the University of Utah (U of U) Neonatal Intensive Care Unit (NICU).
Interventions
- DEVICE Owlet OSS V3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-07-14 |
| Est. Completion | 2021-12-03 |
What the finished NCT05635513 record still lists
NCT05635513 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Owlet OSS V3 is the first listed.
NCT05635513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05635513 about?
NCT05635513 is a clinical study titled "Owlet Smart Sock 3 Accuracy on Infants". The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a standard wired pulse oximeter simultaneously. The monitoring duration with ...
What is the current status of trial NCT05635513?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2021-07-14. Estimated completion is 2021-12-03.
What interventions are being tested in trial NCT05635513?
The interventions under investigation include: Owlet OSS V3 (DEVICE).
Who is sponsoring clinical trial NCT05635513?
This trial is sponsored by Owlet Baby Care, which has 9 total clinical trials registered on ClinicalTrials.gov.
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