At a glance
ClinicalIndex Comparison RecordN/ACompleted· 14 enrolled
Drug / intervention
Owlet Smart Sock Sensor 3rd Generationother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia
In Brief
An observational study evaluating Owlet Smart Sock Sensor 3rd Generation for Hypoxia. Completed, enrolled 14 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHypoxia
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
Enrollment StartMar 2020
Primary CompletionMar 2020
First PostedJun 2020
TodayJul 2026
First PostedJun 24, 2020
Enrollment StartMar 12, 2020
Primary CompletionMar 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1 daysPosted 6.0 years ago
Interventions
Owlet Smart Sock Sensor 3rd Generationother
Pulse Oximetry