<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/NCT03816566</url>
  </required_header>
  <id_info>
    <org_study_id>CL-00001</org_study_id>
    <nct_id>NCT03816566</nct_id>
  </id_info>
  <brief_title>Validation of a Wearable Non-invasive Device (the Patch)</brief_title>
  <official_title>Validation of a Wearable Non-invasive Device (the Patch) to Aid in Diagnosing Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BresoTEC Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BresoTEC 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      BresoTEC has designed and developed a standalone wearable device (the patch), that can record&#xD;
      tracheal sounds with a microphone attached just above the suprasternal notch of the subject.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the&#xD;
      patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2®&#xD;
      with Bluetooth Low Energy. We have developed advanced signal processing algorithms to detect&#xD;
      apneas and hypopneas. Many of these techniques for analyzing breathing sounds and detecting&#xD;
      apneas and hypopneas have been published in peer-reviewed journals.&#xD;
&#xD;
      The goal of this study is to validate the patch against polysomnography (PSG) for use as an&#xD;
      aid in the diagnosis of sleep apnea for adult patients. Our primary objective is to assess&#xD;
      whether the estimated apnea-hypopnea index (AHI) calculated by the patch agrees with the&#xD;
      results of an in-laboratory PSG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 23, 2018</start_date>
  <completion_date type="Anticipated">August 23, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 23, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The outcome assessor performing the automatic analysis of the patch data will be blinded to the PSG scores performed by the Sleep Lab Technicians.&#xD;
The principal investigator responsible for the completion and closing of the study according to the protocol will be blinded to the patch AHI automatic analysis.&#xD;
Similarly, the Sleep Lab Technicians scoring the PSG will be blinded to the patch automatic analysis.&#xD;
By the end of recruiting the target sample size, the data will be un-blinded and statistical analysis will be performed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Estimation of AHI</measure>
    <time_frame>8 months</time_frame>
    <description>Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimation of body position</measure>
    <time_frame>8 months</time_frame>
    <description>Validate the performance of the patch in estimating body position during sleep compared to an in-laboratory PSG.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Wearable Device and PSG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The device under investigation (the patch) will be used in patients undergoing overnight polysomnography simultaneously, to compare the accuracy of the investigational device against the gold standard for the diagnosis of sleep apnea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>patch</intervention_name>
    <description>A standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject. The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2® with Bluetooth Low Energy.</description>
    <arm_group_label>Wearable Device and PSG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria are men and women 18 years and above, who are referred to either&#xD;
             the University Health Network (UHN), Toronto Rehabilitation Institute (TRI) or Toronto&#xD;
             General Hospital sleep laboratories for overnight PSG because of a suspicion of a&#xD;
             sleep disorder. It is intended for the general outpatient population.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are patients with suspected complicated co-morbidities including&#xD;
             in-hospital patients and those who self-report diagnosis of heart failure, recent&#xD;
             stroke, neuromuscular disorders, renal failure, obesity hypoventilation, COPD, or&#xD;
             other severe lung diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clodagh Ryan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toronto General Hospital &amp; Toronto Rehabilitation Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hisham Alshaer, MD, PhD</last_name>
    <phone>416-597-3422</phone>
    <phone_ext>7959</phone_ext>
    <email>Hisham.Alshaer@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Toronto Rehabilitation Institute</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2A2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clodagh Ryan, MD</last_name>
      <phone>416 340 4719</phone>
      <email>Clodagh.Ryan@uhn.ca</email>
    </contact>
    <investigator>
      <last_name>Clodagh Ryan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Clodagh Ryan, MD</last_name>
    </contact>
    <investigator>
      <last_name>Clodagh Ryan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</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>Sleep Apnea Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03816566
org study id: CL-00001
nct id: NCT03816566
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
BresoTEC has designed and developed a standalone wearable device (the patch), that can record
      tracheal sounds with a microphone attached just above the suprasternal notch of the subject.
The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the
      patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2®
      with Bluetooth Low Energy. We have developed advanced signal processing algorithms to detect
      apneas and hypopneas. Many of these techniques for analyzing breathing sounds and detecting
      apneas and hypopneas have been published in peer-reviewed journals.

      The goal of this study is to validate the patch against polysomnography (PSG) for use as an
      aid in the diagnosis of sleep apnea for adult patients. Our primary objective is to assess
      whether the estimated apnea-hypopnea index (AHI) calculated by the patch agrees with the
      results of an in-laboratory PSG.
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
masking description: The outcome assessor performing the automatic analysis of the patch data will be blinded to the PSG scores performed by the Sleep Lab Technicians.
The principal investigator responsible for the completion and closing of the study according to the protocol will be blinded to the patch AHI automatic analysis.
Similarly, the Sleep Lab Technicians scoring the PSG will be blinded to the patch automatic analysis.
By the end of recruiting the target sample size, the data will be un-blinded and statistical analysis will be performed.
measure: Estimation of AHI
time frame: 8 months
description: Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG.
measure: Estimation of body position
time frame: 8 months
description: Validate the performance of the patch in estimating body position during sleep compared to an in-laboratory PSG.
arm group label: Wearable Device and PSG
arm group type: Experimental
description: The device under investigation (the patch) will be used in patients undergoing overnight polysomnography simultaneously, to compare the accuracy of the investigational device against the gold standard for the diagnosis of sleep apnea.
intervention type: Device
intervention name: patch
description: A standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject. The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2® with Bluetooth Low Energy.
arm group label: Wearable Device and PSG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clodagh Ryan, MD
role: Principal Investigator
affiliation: Toronto General Hospital & Toronto Rehabilitation Institute
last name: Hisham Alshaer, MD, PhD
phone: 416-597-3422
phone ext: 7959
email: Hisham.Alshaer@uhn.ca
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
sharing ipd: Undecided