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NCT06850610
Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus
NA trial testing Pulse oximeter accuracy under hypoxic conditions in Hypoxia in 163 participants. Completed in 6 August 2025.
6 August 2025
Quick facts
| Lead sponsor | Owlet Baby Care, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 163 |
| Start date | 24 February 2025 |
| Primary completion | 6 August 2025 |
| Estimated completion | 6 August 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pulse oximeter accuracy under hypoxic conditions
Conditions studied
- Hypoxia — all drugs for Hypoxia →
Sponsor
Owlet Baby Care, Inc.
Who can join
Adults 18 to 49, any sex, with Hypoxia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06850610
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07307560 — High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients · NA · recruiting
- NCT07408388 — Pulse Oximeter Accuracy During Stable Hypoxia Plateaus · active not recruiting
Other Owlet Baby Care, Inc. trials
Trials by the same sponsor.
- NCT07321938 — Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers · NA · recruiting
- NCT05581394 — Accuracy of BabySat V3 With Profound Hypoxia and Motion · completed
- NCT05561946 — An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0 · completed
- NCT05635513 — Owlet Smart Sock 3 Accuracy on Infants · completed
- NCT04446247 — Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06850610 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Owlet Baby Care, Inc.
- Last refreshed: 14 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06850610.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing