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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
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Clinimark, LLC
Information provided by (Responsible Party):
Owlet Baby Care, Inc.

Brief Summary:
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.

Condition or disease Intervention/treatment Phase
Hypoxia Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor Not Applicable

Detailed Description:

Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. A pulse oximeter is a device that measures the oxygen saturation of arterial blood non-invasively.

The purpose of this study was to evaluate the SpO2 accuracy performance of the Owlet BabySat v1.0 and Smart SockTM 2 pulse oximetry OSS v1.1 sensors during non-motion conditions over the range of 70-100% SaO2 to arterial blood samples assessed by CO-Oximetry for a SpO2 validation.

The goal, in its entirety, was to show the SpO2 accuracy performance for the investigational device Owlet Baby Care, Inc. Smart SockTM V. 2.

It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required specification of ARMS 3% or lower in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.

No risks or adverse device effects were expected. There were no contraindications for use in the proposed study population.

The study was conducted in accordance to the code of federal regulations for non-significant risk medical device studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable sections of ISO80601-2-61 (1st edition 2011-04- 01), and Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : December 17, 2017
Actual Study Completion Date : December 17, 2017

Arm Intervention/treatment
Active Comparator: Reference CO-Oximetry Diagnostic Test: 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

Experimental: Owlet BabySat v1.0 Diagnostic Test: 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

Experimental: Owlet Smart Sock V2 v1.1 Diagnostic Test: 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




Primary Outcome Measures :
  1. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 below 3% [ Time Frame: Acute immediate assessment of the sensor accuracy compared to CO-oximetry ]
    SpO2 accuracy for Owlet Smart Sock 2 sensor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance, made up of either.
  • Subject must have the ability to understand and provide written informed consent
  • Subject is 18 to 50 years of age
  • At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger
  • Subject must be willing and able to comply with study procedures and duration
  • Subject is a non-smoker or who have not smoked within 2 days prior to the study.

Exclusion Criteria:

  • Subject is considered as being morbidly obese (defined as BMI >39.5)
  • Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study
  • Females who are pregnant, who are trying to get pregnant
  • Smoker Subjects who have refrained will be screened for COHb levels
  • Subjects with known heart or cardiovascular conditions
  • Subjects with known clotting disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630016


Locations
United States, Utah
Owlet Baby Care, Inc.
Lehi, Utah, United States, 84043
Sponsors and Collaborators
Owlet Baby Care, Inc.
Clinimark, LLC
Investigators
Study Director: Milena Adamian, MD Owlet Baby Care, Inc.

Responsible Party: Owlet Baby Care, Inc.
ClinicalTrials.gov Identifier: NCT03630016     History of Changes
Other Study ID Numbers: PR2017-263
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms