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NCT06771206 · ClinicalTrials.gov registry record · NA
Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
A NA study of Pulse Oximeter Validation, sponsored by Owlet Baby Care.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06771206: Recruiting NA study of Pulse Oximeter Validation, sponsored by Owlet Baby Care.
NCT06771206 is a NA study of Pulse Oximeter Validation that is actively recruiting participants, run by Owlet Baby Care. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06771206, a NA study of Pulse Oximeter Validation, is actively recruiting participants, sponsored by Owlet Baby Care.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date. The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.
Primary Outcome
Accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements from arterial blood gas samples as determined by a root mean square (ARMS) calculation.
Conditions Studied
Interventions
- DEVICE Owlet pulse oximeter neonatal accuracy validation
Study Locations (2)
Alabama
- University of Alabama Birmingham - Children's of Alabama - Birmingham
Minnesota
- University of Minnesota Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2026-02 |
| Phase | NA |
What NCT06771206 shows while recruiting
NCT06771206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 1 condition, with Pulse Oximeter Validation appearing as the primary indexed condition, and to 1 intervention - of which Owlet pulse oximeter neonatal accuracy validation is the first listed.
NCT06771206 reports a single indexed study location in Alabama, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06771206 about?
NCT06771206 is a clinical study titled "Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population". The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital enviro...
What is the current status of trial NCT06771206?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-08-01. Estimated completion is 2026-02.
What conditions does trial NCT06771206 study?
This clinical trial studies the following conditions: Pulse Oximeter Validation.
What interventions are being tested in trial NCT06771206?
The interventions under investigation include: Owlet pulse oximeter neonatal accuracy validation (DEVICE).
Who is sponsoring clinical trial NCT06771206?
This trial is sponsored by Owlet Baby Care, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06771206 being conducted?
This trial has 2 study locations across Alabama, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06771206's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 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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