Trial Outcomes & Findings for Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia (NCT NCT04446247)
NCT ID: NCT04446247
Last Updated: 2020-10-19
Results Overview
Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation
Recruitment status
COMPLETED
Target enrollment
14 participants
Primary outcome timeframe
1 hour
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
ARMS SpO2 70-100%
Comparison to Reference CO-Oximetry Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
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|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia
Baseline characteristics by cohort
| Measure |
ARMS SpO2 70-100%
n=351 Arterial Blood Samples
Comparison to Reference CO-Oximetry Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
Skin Tone
Dark
|
1 Participants
n=5 Participants
|
|
Skin Tone
Dark-Medium
|
4 Participants
n=5 Participants
|
|
Skin Tone
Medium
|
4 Participants
n=5 Participants
|
|
Skin Tone
Light- Medium
|
4 Participants
n=5 Participants
|
|
Skin Tone
Light
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourDetermination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation
Outcome measures
| Measure |
ARMS SpO2 70-100%, Oximeter #1 (Left)
n=211 Number of Data Points
Comparison to Reference CO-Oximetry on the left thumb. Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
|
ARMS SpO2 70-100%, Oximeter #2 (Right)
n=247 Number of Data Points
Comparison to Reference CO-Oximetry on the right thumb.
Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
|
|---|---|---|
|
SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%
|
2.10 Percentage
|
2.19 Percentage
|
Adverse Events
ARMS SpO2 70-100%, Oximeter #1 (Left)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ARMS SpO2 70-100%, Oximeter #2 (Right)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Madison Kenley, Clinical Research Director
Owlet Baby Care, Inc
Phone: 801-552-8383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place