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SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry

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ClinicalTrials.gov Identifier: NCT03630016
Recruitment Status : Completed
First Posted : August 14, 2018
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Clinimark, LLC
Information provided by (Responsible Party):
Owlet Baby Care, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Hypoxia
Intervention Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor
Enrollment 11
Recruitment Details  
Pre-assignment Details Eleven subjects were enrolled into the study with one subject later withdrawn due to poor sensor placement.
Arm/Group Title Owlet Smart Sock V2 v1.1
Hide Arm/Group Description Pulse oximetry with Owlet BabySat v1.0 sensor: A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Reason Not Completed
Poor Sensor Placement             1
Arm/Group Title Owlet Smart Sock V2 v1.1
Hide Arm/Group Description Pulse oximetry with Owlet BabySat v1.0 sensor: A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
29.2  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
2
  20.0%
Not Hispanic or Latino
8
  80.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  20.0%
White
7
  70.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 10 participants
159.8  (25.8)
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 10 participants
68.1  (4.3)
1.Primary Outcome
Title It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100%
Hide Description The purpose of the study was to evaluate the accuracy of the blood oxygen saturation (SpO2) at rest over the range of 70-100% compared to arterial blood samples assessed by standard methods [Co-Oximetry]. A standard pulse oximeter accuracy is evaluated by the Accuracy Root Mean Square (ARMS). The results of accurate performance of the oximetry system require ARMS of 3% or less in non-motion conditions for the range of 70-100% SpO2 per standard.
Time Frame Acute immediate assessment of the sensor accuracy compared to CO-oximetry
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Owlet Smart Sock V2 v1.1
Hide Arm/Group Description:
Pulse oximetry with Owlet BabySat v1.0 sensor: A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
Overall Number of Participants Analyzed 10
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Data Points
226
Measure Type: Number
Unit of Measure: Percent SpO2
2.4
Time Frame Throughout study duration and a follow-up with each subject will be conducted within 7 days following participation in the study and will be conducted via telephone, text or email.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Owlet Smart Sock V2 v1.1
Hide Arm/Group Description Pulse oximetry with Owlet BabySat v1.0 sensor: A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
All-Cause Mortality
Owlet Smart Sock V2 v1.1
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Owlet Smart Sock V2 v1.1
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Owlet Smart Sock V2 v1.1
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Madison Kenley, CCRP, BS
Organization: Owlet Baby Care, Inc.
Phone: 801-552-8383
Responsible Party: Owlet Baby Care, Inc.
ClinicalTrials.gov Identifier: NCT03630016     History of Changes
Other Study ID Numbers: PR2017-263
First Submitted: August 3, 2018
First Posted: August 14, 2018
Results First Submitted: May 9, 2019
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019