<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/NCT03775291</url>
  </required_header>
  <id_info>
    <org_study_id>129-0318-01</org_study_id>
    <nct_id>NCT03775291</nct_id>
  </id_info>
  <brief_title>Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch</brief_title>
  <official_title>Fitbit Sleep Apnea Alert Software Validation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fitbit LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fitbit LLC</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 clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert&#xD;
      software for minimally invasive monitoring of sleep apnea events to alert users of their risk&#xD;
      of sleep apnea. The Sleep Apnea Alert software analyses data from a Fitbit commercially&#xD;
      available wrist photoplethysmogram (PPG) device. The Sleep Apnea Alert software is an&#xD;
      investigational software as medical device (SaMD) and is designed to retrospectively process&#xD;
      data and flag users who have physiological signals consistent with an apnea-hypopnea index&#xD;
      (AHI) of 15 or greater. This clinical validation study will be used to validate Fitbit's&#xD;
      PPG-based sleep apnea algorithm. The outputs of the Fitbit Sleep Apnea Alert software will&#xD;
      not be available to study participants, as the scope of this study is to gather validation&#xD;
      data only and does not include testing product usability components.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 9, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device.</measure>
    <time_frame>Nightly basis averaged over 7 nights.</time_frame>
    <description>Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or &lt;15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate (averaged over 7 nights) from the wearable device. [This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI&lt;15 respectively]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single night comparison between PSG and wearable device data on a per-subject basis</measure>
    <time_frame>1 night</time_frame>
    <description>Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or &lt;15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate on the same night as PSG from the wearable device. [This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI&lt;15 respectively]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single night comparison between PSG and wearable device data on a per-epoch basis</measure>
    <time_frame>1 night</time_frame>
    <description>Percent agreement on a per one-minute epoch basis for the presence of sleep apnea between the polysomnogram and the corresponding simultaneous estimate from the wearable device .</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">303</enrollment>
  <condition>Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Low pre-test likelihood for sleep apnea</arm_group_label>
    <description>Subjects at low risk for having sleep apnea due to lack of known risk factors and no complaints of symptoms related to sleep apnea (e.g., excessive daytime sleepiness)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High pre-test likelihood for sleep apnea</arm_group_label>
    <description>Suspected sleep apnea patients who are undergoing sleep tests as part of normal medical care or are also known to be non-compliant with therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Simultaneous assessment of sleep apnea by polysomnogram and wearable device</intervention_name>
    <description>Characterization of sleep apnea by lab-based polysomnogram</description>
    <arm_group_label>High pre-test likelihood for sleep apnea</arm_group_label>
    <arm_group_label>Low pre-test likelihood for sleep apnea</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects referred to sleep labs for a clinical evaluation or subjects with previous sleep&#xD;
        apnea who are known to be non-compliant with treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable of giving informed consent&#xD;
&#xD;
          -  Comfortable reading the provided written study instructions in English (and/or local&#xD;
             language) and using a smartphone in English (and/or local language).&#xD;
&#xD;
          -  Have medical insurance either in the form of private insurance or a national health&#xD;
             program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No implanted cardiac devices&#xD;
&#xD;
          -  Not pregnant. Pregnancy status will be confirmed per patient report of medical&#xD;
             history, i.e., patients will be asked if they are pregnant or may be pregnant, and&#xD;
             date of last menstrual cycle.&#xD;
&#xD;
          -  No medical conditions which might lead to consistently low levels of perfusion in the&#xD;
             vasculature at the wrist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Conor Heneghan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Fitbit LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jasper Summit Research</name>
      <address>
        <city>Jasper</city>
        <state>Alabama</state>
        <zip>35501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Sleep Center</name>
      <address>
        <city>Burlingame</city>
        <state>California</state>
        <zip>94010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sleep Center Orange County</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurotrials Inc</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SleepMed Inc</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's University Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No: There is not a plan to make IPD available.</ipd_description>
  </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/NCT03775291
org study id: 129-0318-01
nct id: NCT03775291
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert
      software for minimally invasive monitoring of sleep apnea events to alert users of their risk
      of sleep apnea. The Sleep Apnea Alert software analyses data from a Fitbit commercially
      available wrist photoplethysmogram (PPG) device. The Sleep Apnea Alert software is an
      investigational software as medical device (SaMD) and is designed to retrospectively process
      data and flag users who have physiological signals consistent with an apnea-hypopnea index
      (AHI) of 15 or greater. This clinical validation study will be used to validate Fitbit's
      PPG-based sleep apnea algorithm. The outputs of the Fitbit Sleep Apnea Alert software will
      not be available to study participants, as the scope of this study is to gather validation
      data only and does not include testing product usability components.
observational model: Case-Control
time perspective: Prospective
measure: Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device.
time frame: Nightly basis averaged over 7 nights.
description: Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or <15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate (averaged over 7 nights) from the wearable device. [This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI<15 respectively]
measure: Single night comparison between PSG and wearable device data on a per-subject basis
time frame: 1 night
description: Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or <15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate on the same night as PSG from the wearable device. [This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI<15 respectively]
measure: Single night comparison between PSG and wearable device data on a per-epoch basis
time frame: 1 night
description: Percent agreement on a per one-minute epoch basis for the presence of sleep apnea between the polysomnogram and the corresponding simultaneous estimate from the wearable device .
arm group label: Low pre-test likelihood for sleep apnea
description: Subjects at low risk for having sleep apnea due to lack of known risk factors and no complaints of symptoms related to sleep apnea (e.g., excessive daytime sleepiness)
arm group label: High pre-test likelihood for sleep apnea
description: Suspected sleep apnea patients who are undergoing sleep tests as part of normal medical care or are also known to be non-compliant with therapy.
intervention type: Diagnostic Test
intervention name: Simultaneous assessment of sleep apnea by polysomnogram and wearable device
description: Characterization of sleep apnea by lab-based polysomnogram
arm group label: High pre-test likelihood for sleep apnea
arm group label: Low pre-test likelihood for sleep apnea
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Conor Heneghan, PhD
role: Study Director
affiliation: Fitbit LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Ireland
country: United States
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
sharing ipd: No
ipd description: No: There is not a plan to make IPD available.