<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/NCT02987283</url>
  </required_header>
  <id_info>
    <org_study_id>REB 2016-0494</org_study_id>
    <nct_id>NCT02987283</nct_id>
  </id_info>
  <brief_title>Evaluating Accuracy of Breath Sound Recordings and STOP-Bang Screening For Obstructive Sleep Apnea While Awake</brief_title>
  <official_title>Safer Sleep: A Diagnostic Accuracy Study Evaluating Breath Sound Recordings and STOP-Bang In Screening For Obstructive Sleep Apnea While Awake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Ottawa Hospital Academic Medical Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will perform a diagnostic accuracy study comparing tracheal breath sound&#xD;
      recordings in awake individuals to the STOP-Bang screening questionnaire, using the&#xD;
      apnea-hypopnea index (AHI) score determined by polysomnography as the gold standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) is a breathing disorder with numerous health effects including&#xD;
      a greater risk of peri-operative anesthetic complications. Numerous screening tools exist but&#xD;
      are not without limitations. Diagnostic overnight sleep studies are resource-intensive and&#xD;
      difficult to obtain in the short time period between pre-operative clinic assessment and the&#xD;
      day of surgery.&#xD;
&#xD;
      This project aims to test the diagnostic performance of a new screening technology,&#xD;
      Awake-OSA, for screening of obstructive sleep apnea (OSA). &quot;Awake-OSA&quot; uses a small external&#xD;
      microphone placed on the neck, to record and analyze tracheal breath sounds at the bedside&#xD;
      while the patient is awake.&#xD;
&#xD;
      Using polysomnography (PSG) as a gold standard, the investigators will compare Awake-OSA&#xD;
      (breath sound recording) and the STOP-Bang screening questionnaire in their ability to&#xD;
      accurately identify patients with OSA, as well as classify OSA in terms of severity.&#xD;
&#xD;
      Early, point-of-care diagnosis has the potential to provide a low-cost, convenient&#xD;
      alternative to traditional screening questionnaires and enable more selective use of PSG. Our&#xD;
      goal is to improve peri-operative patient safety while improving use of resources and&#xD;
      streamlining patient care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">September 20, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Screening and diagnostic test performance of Awake-OSA and STOP-Bang</measure>
    <time_frame>Night 1</time_frame>
    <description>Screening and diagnostic test performance of Awake-OSA and STOPBang in identifying OSA vs non-OSA patients, using AHI as gold-standard reference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of new diagnostic algorithm determined by predictive values, sensibility, and specificity</measure>
    <time_frame>Through study completion, average two years</time_frame>
    <description>The investigators will calculate positive and negative predictive values, sensibility, and specificity or each diagnostic tool tested in the study as well as for a combination of these tools to determine the best possible diagnostic algorithm for OSA. Positive and negative predictive values, sensibility, and specificity of the resulting diagnostic algorithm will be reported.</description>
  </secondary_outcome>
  <enrollment type="Actual">439</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort will be selected from patients referred to the Ottawa Hospital sleep clinic for a&#xD;
        diagnostic sleep study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and older.&#xD;
&#xD;
          -  Referred for diagnostic sleep study.&#xD;
&#xD;
          -  Willing and able to consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 18 yrs.&#xD;
&#xD;
          -  Unwilling or unable to give consent.&#xD;
&#xD;
          -  Expected to have an abnormal EEG (epilepsy, brain tumour, deep brain stimulator).&#xD;
&#xD;
          -  Significant craniofacial abnormality (ex. unrepaired cleft lip/palate).&#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>Sylvain Boet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>May 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>March 20, 2020</last_update_submitted>
  <last_update_submitted_qc>March 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</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>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 28, 2022</submitted>
    <returned>August 24, 2023</returned>
  </pending_results>
  <!-- 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/NCT02987283
org study id: REB 2016-0494
nct id: NCT02987283
lead sponsor: 
collaborator: 
has dmc: No
The investigators will perform a diagnostic accuracy study comparing tracheal breath sound
      recordings in awake individuals to the STOP-Bang screening questionnaire, using the
      apnea-hypopnea index (AHI) score determined by polysomnography as the gold standard.
Obstructive sleep apnea (OSA) is a breathing disorder with numerous health effects including
      a greater risk of peri-operative anesthetic complications. Numerous screening tools exist but
      are not without limitations. Diagnostic overnight sleep studies are resource-intensive and
      difficult to obtain in the short time period between pre-operative clinic assessment and the
      day of surgery.

      This project aims to test the diagnostic performance of a new screening technology,
      Awake-OSA, for screening of obstructive sleep apnea (OSA). "Awake-OSA" uses a small external
      microphone placed on the neck, to record and analyze tracheal breath sounds at the bedside
      while the patient is awake.

      Using polysomnography (PSG) as a gold standard, the investigators will compare Awake-OSA
      (breath sound recording) and the STOP-Bang screening questionnaire in their ability to
      accurately identify patients with OSA, as well as classify OSA in terms of severity.

      Early, point-of-care diagnosis has the potential to provide a low-cost, convenient
      alternative to traditional screening questionnaires and enable more selective use of PSG. Our
      goal is to improve peri-operative patient safety while improving use of resources and
      streamlining patient care.
observational model: Cohort
time perspective: Prospective
measure: Screening and diagnostic test performance of Awake-OSA and STOP-Bang
time frame: Night 1
description: Screening and diagnostic test performance of Awake-OSA and STOPBang in identifying OSA vs non-OSA patients, using AHI as gold-standard reference.
measure: Development of new diagnostic algorithm determined by predictive values, sensibility, and specificity
time frame: Through study completion, average two years
description: The investigators will calculate positive and negative predictive values, sensibility, and specificity or each diagnostic tool tested in the study as well as for a combination of these tools to determine the best possible diagnostic algorithm for OSA. Positive and negative predictive values, sensibility, and specificity of the resulting diagnostic algorithm will be reported.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sylvain Boet, MD
role: Principal Investigator
affiliation: The Ottawa Hospital
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided
submitted: September 28, 2022
returned: August 24, 2023