<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04446247</url>
  </required_header>
  <id_info>
    <org_study_id>10-00437</org_study_id>
    <nct_id>NCT04446247</nct_id>
  </id_info>
  <brief_title>Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia</brief_title>
  <official_title>Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Owlet Baby Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Owlet Baby Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen&#xD;
      desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia&#xD;
      has been attained. The blood sample is analyzed for oxygen saturation with a gold standard&#xD;
      bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents&#xD;
      for pulse oximeter testing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2020</start_date>
  <completion_date type="Actual">March 13, 2020</completion_date>
  <primary_completion_date type="Actual">March 13, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%</measure>
    <time_frame>1 hour</time_frame>
    <description>Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation</description>
  </primary_outcome>
  <enrollment type="Actual">14</enrollment>
  <condition>Hypoxia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Owlet Smart Sock Sensor 3rd Generation</intervention_name>
    <description>Pulse Oximetry</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants in this study should be healthy, between 18 and 50 years of age and willing to&#xD;
        participate in breathing studies with or without blood samples in San Francisco.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject is male or female, aged ≥18 and &lt;50.&#xD;
&#xD;
          -  The subject is in good general health with no evidence of any medical problems.&#xD;
&#xD;
          -  The subject is fluent in both written and spoken English.&#xD;
&#xD;
          -  The subject has provided informed consent and is willing to comply with the study&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is obese (BMI&gt;30).&#xD;
&#xD;
          -  The subject has a known history of heart disease, lung disease, kidney or liver&#xD;
             disease.&#xD;
&#xD;
          -  Diagnosis of asthma, sleep apnea, or use of CPAP.&#xD;
&#xD;
          -  Subject has diabetes.&#xD;
&#xD;
          -  Subject has a clotting disorder.&#xD;
&#xD;
          -  The subject a hemoglobinopathy or history of anemia, per subject report or the first&#xD;
             blood sample, that in the opinion of the investigator, would make them unsuitable for&#xD;
             study participation.&#xD;
&#xD;
          -  The subject has any other serious systemic illness.&#xD;
&#xD;
          -  The subject is a current smoker.&#xD;
&#xD;
          -  Any injury, deformity, or abnormality at the sensor sites that in the opinion of the&#xD;
             investigators' would interfere with the sensors working correctly.&#xD;
&#xD;
          -  The subject has a history of fainting or vasovagal response.&#xD;
&#xD;
          -  The subject has a history of sensitivity to local anesthesia.&#xD;
&#xD;
          -  The subject has a diagnosis of Raynaud's disease.&#xD;
&#xD;
          -  The subject has unacceptable collateral circulation based on exam by the investigator&#xD;
             (Allen's test).&#xD;
&#xD;
          -  The subject is pregnant, lactating or trying to get pregnant.&#xD;
&#xD;
          -  The subject is unable or unwilling to provide informed consent, or is unable or&#xD;
             unwilling to comply with study procedures.&#xD;
&#xD;
          -  The subject has any other condition, which in the opinion of the investigators' would&#xD;
             make them unsuitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Bickler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSF Department of Anesthesia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Feiner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSF Department of Anesthesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University California San Fransisco, Department of Anesthesia</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <results_first_submitted>June 24, 2020</results_first_submitted>
  <results_first_submitted_qc>September 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2020</results_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Verification of SpO2 accuracy</keyword>
  <keyword>Induced hypoxia</keyword>
  <keyword>Owlet Smart Sock</keyword>
  <keyword>Pulse oximeter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT04446247/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ARMS SpO2 70-100%</title>
          <description>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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>14 Healthy volunteer subjects</population>
      <group_list>
        <group group_id="B1">
          <title>ARMS SpO2 70-100%</title>
          <description>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.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Arterial Blood Samples</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="351"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Skin Tone</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>Dark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dark-Medium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Light- Medium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Light</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%</title>
        <description>Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation</description>
        <time_frame>1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARMS SpO2 70-100%, Oximeter #1 (Left)</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>ARMS SpO2 70-100%, Oximeter #2 (Right)</title>
            <description>Comparison to Reference CO-Oximetry on the right thumb.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%</title>
          <description>Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation</description>
          <units>Percentage</units>
          <param>Number</param>
          <units_analyzed>Number of Data Points</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of Data Points</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="211"/>
                <count group_id="O2" value="247"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.10"/>
                    <measurement group_id="O2" value="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study Duration (approximately 1 hour)</time_frame>
      <desc>All subjects completed the study without events.</desc>
      <group_list>
        <group group_id="E1">
          <title>ARMS SpO2 70-100%, Oximeter #1 (Left)</title>
          <description>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.</description>
        </group>
        <group group_id="E2">
          <title>ARMS SpO2 70-100%, Oximeter #2 (Right)</title>
          <description>Comparison to Reference CO-Oximetry on the left thumb.&#xD;
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.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Madison Kenley, Clinical Research Director</name_or_title>
      <organization>Owlet Baby Care, Inc</organization>
      <phone>801-552-8383</phone>
      <email>mkenley@owletcare.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04446247
org study id: 10-00437
nct id: NCT04446247
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Prospective
measure: SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%
time frame: 1 hour
description: Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation
intervention type: Diagnostic Test
intervention name: Owlet Smart Sock Sensor 3rd Generation
description: Pulse Oximetry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip Bickler, MD
role: Principal Investigator
affiliation: UCSF Department of Anesthesia
last name: John Feiner, MD
role: Principal Investigator
affiliation: UCSF Department of Anesthesia
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypoxia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 