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NCT05581394
Accuracy of BabySat V3 With Profound Hypoxia and Motion
trial testing BabySat V3 in Hypoxia in 12 participants. Completed in 15 July 2022.
15 July 2022
Quick facts
| Lead sponsor | Owlet Baby Care, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 12 |
| Start date | 14 July 2022 |
| Primary completion | 15 July 2022 |
| Estimated completion | 15 July 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- BabySat V3
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
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.
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 NCT05581394
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypoxia
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- 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
- NCT06850610 — Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus · NA · 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 NCT05581394 (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 October 2022
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/NCT05581394.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing