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NCT05581394 · ClinicalTrials.gov registry record

Accuracy of BabySat V3 With Profound Hypoxia and Motion

A clinical trial of Hypoxia, sponsored by Owlet Baby Care.

Completed
Registry status
12
Enrollment target
1
Study location

NCT05581394 is a study of Hypoxia that has completed, run by Owlet Baby Care. The registered enrollment target is 12 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.

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The verdict

NCT05581394, a study of Hypoxia, has completed, sponsored by Owlet Baby Care.

COMPLETED
Registry status
12 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 and during different motion scenarios. 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.

Conditions Studied

Interventions

  • DEVICE BabySat V3

Study Locations (1)

California

  • University California San Fransisco, Department of Anesthesia - San Francisco

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2022-07-14
Est. Completion 2022-07-15

Sponsor

Owlet Baby Care

9 total trials

What the Registry Record Tells You About NCT05581394

The ClinicalTrials.gov registry entry for NCT05581394 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,117-participant average among 39 other Hypoxia trials with a reported enrollment target (100% lower). The listed sponsor is Owlet Baby Care, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypoxia appearing as the primary indexed condition, and to 1 intervention - of which BabySat V3 is the first listed.

NCT05581394 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05581394 about?

NCT05581394 is a clinical study titled "Accuracy of BabySat V3 With Profound Hypoxia and Motion". 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 and during different motion scenarios. The blood sample is analyzed for oxygen saturation with a ...

What is the current status of trial NCT05581394?

This trial is currently completed. The enrollment target is 12 participants. The study started on 2022-07-14. Estimated completion is 2022-07-15.

What conditions does trial NCT05581394 study?

This clinical trial studies the following conditions: Hypoxia.

What interventions are being tested in trial NCT05581394?

The interventions under investigation include: BabySat V3 (DEVICE).

Who is sponsoring clinical trial NCT05581394?

This trial is sponsored by Owlet Baby Care, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05581394 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.