<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/NCT04419051</url>
  </required_header>
  <id_info>
    <org_study_id>OWLB</org_study_id>
    <nct_id>NCT04419051</nct_id>
  </id_info>
  <brief_title>Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers</brief_title>
  <official_title>Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers</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>
      This is an observational research study of a new pregnancy tracker used to gather information&#xD;
      about a pregnant woman's general wellness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Owlet Band is a wellness product (similar to a fitbit), it is not designed to be a&#xD;
      &quot;medical device&quot;. The study involves women age 18 and older who are currently pregnant, at&#xD;
      least 24 weeks' gestation or later, and who live in the USA. Up to 8,000 pregnant women are&#xD;
      expected to participate in the study. This study will involve review of Owlet Band data and&#xD;
      participant responses to questionnaires throughout the study. The purpose of this research is&#xD;
      to observe if using the new Owlet Band and the associated iPhone app can help pregnant women&#xD;
      in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant,&#xD;
      while still maintaining their standard medical care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gather information</measure>
    <time_frame>From date of enrollment until the date of reported delivery or early termination , whichever came first, assessed up to 16 weeks</time_frame>
    <description>Successful collection of Owlet Band data from study participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gather information</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>Completion of study questionnaires by at least 500 participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Management of anxiety State Trait Anxiety Inventory</measure>
    <time_frame>Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days)</time_frame>
    <description>Change in anxiety as assessed by State Trait Anxiety Inventory (STAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Management of stress (Perceived Stress Scale)</measure>
    <time_frame>Participant completion of the PSS questionnaire before wearing the Owlet Band and at Day 31 and Day 52 (+3 days)</time_frame>
    <description>Change in perceived stress as assessed by Perceived Stress Scale (PSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant's experience while using the Owlet Band</measure>
    <time_frame>Through study completion, up to 16 weeks</time_frame>
    <description>Self-report of bonding and connection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintenance of standard medical care</measure>
    <time_frame>Through study completion, up to 16 weeks</time_frame>
    <description>Self-Report of standard medical care and unexpected or unscheduled visits</description>
  </secondary_outcome>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>Pregnancy</condition>
  <condition>Anxiety</condition>
  <condition>Stress</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Owlet Band</intervention_name>
    <description>The Owlet Band is a wearable fabric band pregnancy tracker made up of small sensors that are able to detect natural low-level electrical signals normally produced by the mother's heart and baby's (fetal) heart.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women 24 weeks' gestation and later&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be at least 24 weeks pregnant with a singleton pregnancy&#xD;
&#xD;
          -  Must be at least 18 years of age&#xD;
&#xD;
          -  Must currently live in the United States&#xD;
&#xD;
          -  Must have a compatible smartphone (Apple iOS Version 13 or above)&#xD;
&#xD;
          -  Able to read and understand English in order to provide Informed Consent and follow&#xD;
             study instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Madison Kenley, BS, CCRC</last_name>
    <phone>801-783-3522</phone>
    <email>mkenley@owletcare.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kenneth Ward, MD</last_name>
    <phone>801-783-3522</phone>
    <email>kward@owletcare.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Owlet Baby Care, Inc.</name>
      <address>
        <city>Lehi</city>
        <state>Utah</state>
        <zip>84043</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Madison Kenley, BS, CCRC</last_name>
      <phone>801-552-8383</phone>
      <email>mkenley@owletcare.com</email>
    </contact>
    <investigator>
      <last_name>Kenneth Ward, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>February 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>September 29, 2020</last_update_submitted>
  <last_update_submitted_qc>September 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Owlet</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Digital Health</keyword>
  <keyword>Wellness</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04419051
org study id: OWLB
nct id: NCT04419051
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational research study of a new pregnancy tracker used to gather information
      about a pregnant woman's general wellness.
The Owlet Band is a wellness product (similar to a fitbit), it is not designed to be a
      "medical device". The study involves women age 18 and older who are currently pregnant, at
      least 24 weeks' gestation or later, and who live in the USA. Up to 8,000 pregnant women are
      expected to participate in the study. This study will involve review of Owlet Band data and
      participant responses to questionnaires throughout the study. The purpose of this research is
      to observe if using the new Owlet Band and the associated iPhone app can help pregnant women
      in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant,
      while still maintaining their standard medical care.
observational model: Ecologic or Community
time perspective: Prospective
measure: Gather information
time frame: From date of enrollment until the date of reported delivery or early termination , whichever came first, assessed up to 16 weeks
description: Successful collection of Owlet Band data from study participants
measure: Gather information
time frame: Up to 16 weeks
description: Completion of study questionnaires by at least 500 participants
measure: Management of anxiety State Trait Anxiety Inventory
time frame: Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days)
description: Change in anxiety as assessed by State Trait Anxiety Inventory (STAI)
measure: Management of stress (Perceived Stress Scale)
time frame: Participant completion of the PSS questionnaire before wearing the Owlet Band and at Day 31 and Day 52 (+3 days)
description: Change in perceived stress as assessed by Perceived Stress Scale (PSS)
measure: Participant's experience while using the Owlet Band
time frame: Through study completion, up to 16 weeks
description: Self-report of bonding and connection
measure: Maintenance of standard medical care
time frame: Through study completion, up to 16 weeks
description: Self-Report of standard medical care and unexpected or unscheduled visits
intervention type: Other
intervention name: Owlet Band
description: The Owlet Band is a wearable fabric band pregnancy tracker made up of small sensors that are able to detect natural low-level electrical signals normally produced by the mother's heart and baby's (fetal) heart.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Madison Kenley, BS, CCRC
phone: 801-783-3522
email: mkenley@owletcare.com
last name: Kenneth Ward, MD
phone: 801-783-3522
email: kward@owletcare.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No