Adults 18 to 49, any sex, with Hypoxia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%Primary· 1 hour
Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation
Group
Value
95% CI
ARMS SpO2 70-100%, Oximeter #1 (Left)
2.10
ARMS SpO2 70-100%, Oximeter #2 (Right)
2.19
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. 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.
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Trials by the same sponsor.
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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: 19 October 2020
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/NCT04446247.