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NCT06850610 · ClinicalTrials.gov registry record · NA
Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus
A NA study of Hypoxia, sponsored by Owlet Baby Care.
- Completed
- Registry status
- NA
- Development phase
- 163
- Enrollment target
- 1
- Study location
NCT06850610 is a NA study of Hypoxia that has completed, run by Owlet Baby Care. The registered enrollment target is 163 participants, below the 3,113-participant average among 39 other Hypoxia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06850610, a NA study of Hypoxia, has completed, sponsored by Owlet Baby Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 163 participants
- Enrollment target
- 1
- Study location
Study Summary
This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test pulse oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen saturations. The arterial blood sample is processed in a device called a multi-wavelength hemoximeter and compared to the simultaneous oximeter reading. During each set level of oxygen the participant may be asked to have a motion simulator device apply different types of movement to their hands to assess the pulse oximeter's accuracy during motion. This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age. Testing should require approximately an hour and 15 minutes of the participant's time.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Pulse oximeter accuracy under hypoxic conditions
Study Locations (1)
California
- Vital Signs Research Group - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2025-08-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06850610
The ClinicalTrials.gov registry entry for NCT06850610 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,113-participant average among 39 other Hypoxia trials with a reported enrollment target (95% 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 Pulse oximeter accuracy under hypoxic conditions is the first listed.
NCT06850610 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06850610 about?
NCT06850610 is a clinical study titled "Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus". This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test pulse oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressiv...
What is the current status of trial NCT06850610?
This trial is currently completed. It is a NA study. The enrollment target is 163 participants. The study started on 2025-02-24. Estimated completion is 2025-08-06.
What conditions does trial NCT06850610 study?
This clinical trial studies the following conditions: Hypoxia.
What interventions are being tested in trial NCT06850610?
The interventions under investigation include: Pulse oximeter accuracy under hypoxic conditions (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06850610?
This trial is sponsored by Owlet Baby Care, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06850610 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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Related
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