<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/NCT03025464</url>
  </required_header>
  <id_info>
    <org_study_id>R42MD008845-02</org_study_id>
    <nct_id>NCT03025464</nct_id>
  </id_info>
  <brief_title>Validation of Sleep Apnea Screening Device Phase II</brief_title>
  <official_title>Wireless Sensor Patch for Educing Barriers to In-home Sleep Apnea Screening, Phase II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zansors</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</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>
      Obstructive sleep apnea (OSA) is the most common type of sleep apnea. The marketplace&#xD;
      currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA&#xD;
      screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA&#xD;
      screening tool would allow greater screening of at-risk individuals, especially in&#xD;
      underserved communities with low socioeconomic status, hopefully encouraging a greater&#xD;
      proportion of such individuals to seek treatment for their condition. Over the past year,&#xD;
      this investigative team has engineered a small screening device (Zerify®) for OSA and&#xD;
      obtained preliminary evidence of its efficacy in a clinical population under a&#xD;
      NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a&#xD;
      small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data,&#xD;
      transfer these data to a computer, and detect non-clinical simulated apnea events with a&#xD;
      specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary&#xD;
      psychometric performance data of the screening device in a clinical sample of 52 patients&#xD;
      (13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard&#xD;
      polysomnography. Phase II proposal aims to optimize the engineered hardware and associated&#xD;
      OSA algorithms, create a patient companion app and wireless healthcare provider dashboard,&#xD;
      and compare the efficacy of this screening device to the most commonly utilized sleep apnea&#xD;
      screener, the home sleep apnea test (HSAT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An alternative to polysomnography (PSG), which is done overnight in a lab, is home sleep&#xD;
      apnea testing (HSAT). Also known as out-of-center testing, HSAT has emerged as a more&#xD;
      convenient and increasingly widely used method to screen for sleep apnea. HSAT records fewer&#xD;
      signals for assessment, is less cumbersome than traditional PSG, and allows patients to spend&#xD;
      the night at home, eliminating the need for technical staff to be present during testing.&#xD;
      HSAT is considerably less expensive than PSG to perform. Despite its advantages, there are&#xD;
      concerns about false-negatives and underestimation of disease severity with HSAT. There is&#xD;
      clearly a need to improve the accuracy of less costly screening tools for OSA. Zansors®&#xD;
      wireless microsensor is a novel device to screen for sleep apnea, which measures breathing&#xD;
      patterns and movement, and which will collect data and communicate with a smartphone via&#xD;
      Bluetooth. In this study, investigators are comparing the Zansors microsensor to HSAT and PSG&#xD;
      to assess its accuracy. Patients will be asked to wear the device during the clinical HSAT&#xD;
      ordered by their doctor, and again at an in-laboratory sleep study. When patients are being&#xD;
      trained to use the HSAT equipment, research staff will also show them how to put the Zansors®&#xD;
      device on. They will then wear it at home on the night of their HSAT. At a later date, when&#xD;
      they come for the in-laboratory sleep study, the device will again be worn overnight while&#xD;
      they are being assessed by the full PSG equipment. Together in this study, all these device&#xD;
      recordings will help to detect any sleep apnea and researchers will compare the results of&#xD;
      the Zansors ® microsensor with HSAT and PSG equipment. If the Zansors ® device is confirmed&#xD;
      to detect sleep hypopneas and apneas accurately, it can be used easily and inexpensively by&#xD;
      people at home to screen for obstructive sleep apnea.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was discontinued prematurely due to funding insecurity&#xD;
  </why_stopped>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Specificity</measure>
    <time_frame>8 hours</time_frame>
    <description>Specificity of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>8 hours</time_frame>
    <description>Sensitivity of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Predictive Value (PPV)</measure>
    <time_frame>8 hours</time_frame>
    <description>PPV of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Predictive Value (NPV)</measure>
    <time_frame>8 hours</time_frame>
    <description>NPV of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Obstructive Sleep Apnea Screening Device</intervention_name>
    <description>Assessment of ability of device to detect apneas and hypopneas to screen for OSA</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be over 18 and referred by medical staff for an assessment for suspected sleep&#xD;
             apnea using either a home sleep apnea testing device or in-lab PSG equipment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Heart disease including congestive heart failure or a pacemaker&#xD;
&#xD;
          -  Breathing disorder (emphysema or chronic obstructive breathing disorder)&#xD;
&#xD;
          -  Neurological disorder such as Parkinson's Disease&#xD;
&#xD;
          -  Restless leg syndrome or Periodic limb movement&#xD;
&#xD;
          -  Allergies to metal&#xD;
&#xD;
          -  Pre-existing skin conditions where sensor would be attached&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>J. Todd Arnedt</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <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/NCT03025464
org study id: R42MD008845-02
nct id: NCT03025464
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obstructive sleep apnea (OSA) is the most common type of sleep apnea. The marketplace
      currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA
      screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA
      screening tool would allow greater screening of at-risk individuals, especially in
      underserved communities with low socioeconomic status, hopefully encouraging a greater
      proportion of such individuals to seek treatment for their condition. Over the past year,
      this investigative team has engineered a small screening device (Zerify®) for OSA and
      obtained preliminary evidence of its efficacy in a clinical population under a
      NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a
      small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data,
      transfer these data to a computer, and detect non-clinical simulated apnea events with a
      specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary
      psychometric performance data of the screening device in a clinical sample of 52 patients
      (13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard
      polysomnography. Phase II proposal aims to optimize the engineered hardware and associated
      OSA algorithms, create a patient companion app and wireless healthcare provider dashboard,
      and compare the efficacy of this screening device to the most commonly utilized sleep apnea
      screener, the home sleep apnea test (HSAT).
An alternative to polysomnography (PSG), which is done overnight in a lab, is home sleep
      apnea testing (HSAT). Also known as out-of-center testing, HSAT has emerged as a more
      convenient and increasingly widely used method to screen for sleep apnea. HSAT records fewer
      signals for assessment, is less cumbersome than traditional PSG, and allows patients to spend
      the night at home, eliminating the need for technical staff to be present during testing.
      HSAT is considerably less expensive than PSG to perform. Despite its advantages, there are
      concerns about false-negatives and underestimation of disease severity with HSAT. There is
      clearly a need to improve the accuracy of less costly screening tools for OSA. Zansors®
      wireless microsensor is a novel device to screen for sleep apnea, which measures breathing
      patterns and movement, and which will collect data and communicate with a smartphone via
      Bluetooth. In this study, investigators are comparing the Zansors microsensor to HSAT and PSG
      to assess its accuracy. Patients will be asked to wear the device during the clinical HSAT
      ordered by their doctor, and again at an in-laboratory sleep study. When patients are being
      trained to use the HSAT equipment, research staff will also show them how to put the Zansors®
      device on. They will then wear it at home on the night of their HSAT. At a later date, when
      they come for the in-laboratory sleep study, the device will again be worn overnight while
      they are being assessed by the full PSG equipment. Together in this study, all these device
      recordings will help to detect any sleep apnea and researchers will compare the results of
      the Zansors ® microsensor with HSAT and PSG equipment. If the Zansors ® device is confirmed
      to detect sleep hypopneas and apneas accurately, it can be used easily and inexpensively by
      people at home to screen for obstructive sleep apnea.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Specificity
time frame: 8 hours
description: Specificity of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.
measure: Sensitivity
time frame: 8 hours
description: Sensitivity of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.
measure: Positive Predictive Value (PPV)
time frame: 8 hours
description: PPV of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.
measure: Negative Predictive Value (NPV)
time frame: 8 hours
description: NPV of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.
intervention type: Device
intervention name: Obstructive Sleep Apnea Screening Device
description: Assessment of ability of device to detect apneas and hypopneas to screen for OSA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: J. Todd Arnedt
investigator title: Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No