<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/NCT04443582</url>
  </required_header>
  <id_info>
    <org_study_id>202001068</org_study_id>
    <nct_id>NCT04443582</nct_id>
  </id_info>
  <brief_title>Point-of-care-Ultrasound for Sleep Apnea</brief_title>
  <official_title>An Exploratory Study of Correlating Point Of Care Ultrasound (POCUS) Measures of Sleep Apnea With STOP-BANG Scoring and Apnea-Hypopnea Index (AHI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rakesh Sondekoppam Vijayashankar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</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>
      Patients with obstructive sleep apnea (OSA) are at risk for respiratory dysfunction in the&#xD;
      perioperative environment. The study is designed to evaluate if point-of-care-ultrasound&#xD;
      (POCUS) measurements of upper airway anatomy may identify patients with OSA and their&#xD;
      severity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) is characterized by recurrent collapse of the pharyngeal airway&#xD;
      during sleep, resulting in substantially reduced (hypopnea) or complete cessation (apnea) of&#xD;
      airflow despite ongoing breathing efforts. OSA has long been recognized as a heterogeneous&#xD;
      disorder with potentially multiple contributing pathophysiological causes but with&#xD;
      significant impact to perioperative morbidity. Various OSA phenotypes exist but, the&#xD;
      predominant feature is a narrow and collapsible upper airway anatomy and is an interplay&#xD;
      between pharyngeal soft tissue, genioglossus muscle tone and the bony anatomy and accounts&#xD;
      for up to two-thirds of the variation in the AHI. Identification of moderate-severe OSA is&#xD;
      crucial to prevent potential life-threatening cardiopulmonary complications&#xD;
      perioperatively.(1) However, a large proportion of patients with OSA remain undiagnosed at&#xD;
      the time of surgery.(2) Current screening tools are mainly questionnaire based and are&#xD;
      largely sensitive but not specific (3) resulting in many false positives, unnecessary&#xD;
      increased resource utilization, cost burden, and legal implications. Gold standard laboratory&#xD;
      polysomnography(PSG) study is expensive and not widely available. Point-of-care ultrasound&#xD;
      (POCUS) is a readily available, portable, noninvasive tool that has been used for airway&#xD;
      evaluation and may be useful for OSA screening.(4-8) Study investigators want to evaluate the&#xD;
      various POCUS measures of OSA in the perioperative population and correlate these&#xD;
      measurements with the PSG based severity of OSA (based on apnea-hypopnea index -AHI) to find&#xD;
      out the best measure or a combination of measures to diagnose the incidence and severity of&#xD;
      OSA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of POCUS measurements with AHI and/or STOP-Bang Scores</measure>
    <time_frame>1 day</time_frame>
    <description>The study is designed to assess if there is a correlation of one or a combination of point-of-care-ultrasound measurements with the severity of OSA as denoted by apnea-hypopnea index (AHI) from previous sleep study and/or STOP-Bang scores noted for the presence of OSA in screening exam prior to surgical procedures that require intubation.&#xD;
STOP-Bang denotes Snoring, Tired, Observed (anyone observed you stop breathing), Pressure (high blood pressure), Body mass index (more than 35 kg/m2), Age (older than 50), Neck size, Gender</description>
  </primary_outcome>
  <enrollment type="Actual">140</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting for surgeries who meet eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of either gender&#xD;
&#xD;
          -  Age 18 through 85&#xD;
&#xD;
          -  History of previous sleep study polysomnography (PSG)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No prior sleep study&#xD;
&#xD;
          -  History of central sleep apnea&#xD;
&#xD;
          -  Craniofacial/oropharyngeal malformations&#xD;
&#xD;
          -  Oropharyngeal surgery since the last sleep study&#xD;
&#xD;
          -  Ear/Nose/Throat tumor&#xD;
&#xD;
          -  History of Ear/Nose/Throat surgery&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rakesh V. Sondekoppam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Memtsoudis SG, Stundner O, Rasul R, Chiu YL, Sun X, Ramachandran SK, Kaw R, Fleischut P, Mazumdar M. The impact of sleep apnea on postoperative utilization of resources and adverse outcomes. Anesth Analg. 2014 Feb;118(2):407-418. doi: 10.1213/ANE.0000000000000051.</citation>
    <PMID>24445639</PMID>
  </reference>
  <reference>
    <citation>Singh M, Liao P, Kobah S, Wijeysundera DN, Shapiro C, Chung F. Proportion of surgical patients with undiagnosed obstructive sleep apnoea. Br J Anaesth. 2013 Apr;110(4):629-36. doi: 10.1093/bja/aes465. Epub 2012 Dec 19.</citation>
    <PMID>23257990</PMID>
  </reference>
  <reference>
    <citation>Nagappa M, Liao P, Wong J, Auckley D, Ramachandran SK, Memtsoudis S, Mokhlesi B, Chung F. Validation of the STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea among Different Populations: A Systematic Review and Meta-Analysis. PLoS One. 2015 Dec 14;10(12):e0143697. doi: 10.1371/journal.pone.0143697. eCollection 2015.</citation>
    <PMID>26658438</PMID>
  </reference>
  <reference>
    <citation>Chen JW, Chang CH, Wang SJ, Chang YT, Huang CC. Submental ultrasound measurement of dynamic tongue base thickness in patients with obstructive sleep apnea. Ultrasound Med Biol. 2014 Nov;40(11):2590-8. doi: 10.1016/j.ultrasmedbio.2014.06.019. Epub 2014 Sep 12.</citation>
    <PMID>25220277</PMID>
  </reference>
  <reference>
    <citation>Lahav Y, Rosenzweig E, Heyman Z, Doljansky J, Green A, Dagan Y. Tongue base ultrasound: a diagnostic tool for predicting obstructive sleep apnea. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):179-84. doi: 10.1177/000348940911800304.</citation>
    <PMID>19374148</PMID>
  </reference>
  <reference>
    <citation>Liu KH, Chu WC, To KW, Ko FW, Tong MW, Chan JW, Hui DS. Sonographic measurement of lateral parapharyngeal wall thickness in patients with obstructive sleep apnea. Sleep. 2007 Nov;30(11):1503-8. doi: 10.1093/sleep/30.11.1503.</citation>
    <PMID>18041482</PMID>
  </reference>
  <reference>
    <citation>Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.</citation>
    <PMID>23675433</PMID>
  </reference>
  <reference>
    <citation>Siegel H, Sonies BC, Graham B, McCutchen C, Hunter K, Vega-Bermudez F, Sato S. Obstructive sleep apnea: A study by simultaneous polysomnography and ultrasonic imaging. Neurology. 2000 May 9;54(9):1872. doi: 10.1212/wnl.54.9.1872. No abstract available.</citation>
    <PMID>10802805</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>February 25, 2022</last_update_submitted>
  <last_update_submitted_qc>February 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Rakesh Sondekoppam Vijayashankar</investigator_full_name>
    <investigator_title>Principle Investigator</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/NCT04443582
org study id: 202001068
nct id: NCT04443582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with obstructive sleep apnea (OSA) are at risk for respiratory dysfunction in the
      perioperative environment. The study is designed to evaluate if point-of-care-ultrasound
      (POCUS) measurements of upper airway anatomy may identify patients with OSA and their
      severity.
Obstructive sleep apnea (OSA) is characterized by recurrent collapse of the pharyngeal airway
      during sleep, resulting in substantially reduced (hypopnea) or complete cessation (apnea) of
      airflow despite ongoing breathing efforts. OSA has long been recognized as a heterogeneous
      disorder with potentially multiple contributing pathophysiological causes but with
      significant impact to perioperative morbidity. Various OSA phenotypes exist but, the
      predominant feature is a narrow and collapsible upper airway anatomy and is an interplay
      between pharyngeal soft tissue, genioglossus muscle tone and the bony anatomy and accounts
      for up to two-thirds of the variation in the AHI. Identification of moderate-severe OSA is
      crucial to prevent potential life-threatening cardiopulmonary complications
      perioperatively.(1) However, a large proportion of patients with OSA remain undiagnosed at
      the time of surgery.(2) Current screening tools are mainly questionnaire based and are
      largely sensitive but not specific (3) resulting in many false positives, unnecessary
      increased resource utilization, cost burden, and legal implications. Gold standard laboratory
      polysomnography(PSG) study is expensive and not widely available. Point-of-care ultrasound
      (POCUS) is a readily available, portable, noninvasive tool that has been used for airway
      evaluation and may be useful for OSA screening.(4-8) Study investigators want to evaluate the
      various POCUS measures of OSA in the perioperative population and correlate these
      measurements with the PSG based severity of OSA (based on apnea-hypopnea index -AHI) to find
      out the best measure or a combination of measures to diagnose the incidence and severity of
      OSA.
observational model: Case-Only
time perspective: Prospective
measure: Correlation of POCUS measurements with AHI and/or STOP-Bang Scores
time frame: 1 day
description: The study is designed to assess if there is a correlation of one or a combination of point-of-care-ultrasound measurements with the severity of OSA as denoted by apnea-hypopnea index (AHI) from previous sleep study and/or STOP-Bang scores noted for the presence of OSA in screening exam prior to surgical procedures that require intubation.
STOP-Bang denotes Snoring, Tired, Observed (anyone observed you stop breathing), Pressure (high blood pressure), Body mass index (more than 35 kg/m2), Age (older than 50), Neck size, Gender
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Rakesh V. Sondekoppam, MD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
citation: Memtsoudis SG, Stundner O, Rasul R, Chiu YL, Sun X, Ramachandran SK, Kaw R, Fleischut P, Mazumdar M. The impact of sleep apnea on postoperative utilization of resources and adverse outcomes. Anesth Analg. 2014 Feb;118(2):407-418. doi: 10.1213/ANE.0000000000000051.
PMID: 24445639
citation: Singh M, Liao P, Kobah S, Wijeysundera DN, Shapiro C, Chung F. Proportion of surgical patients with undiagnosed obstructive sleep apnoea. Br J Anaesth. 2013 Apr;110(4):629-36. doi: 10.1093/bja/aes465. Epub 2012 Dec 19.
PMID: 23257990
citation: Nagappa M, Liao P, Wong J, Auckley D, Ramachandran SK, Memtsoudis S, Mokhlesi B, Chung F. Validation of the STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea among Different Populations: A Systematic Review and Meta-Analysis. PLoS One. 2015 Dec 14;10(12):e0143697. doi: 10.1371/journal.pone.0143697. eCollection 2015.
PMID: 26658438
citation: Chen JW, Chang CH, Wang SJ, Chang YT, Huang CC. Submental ultrasound measurement of dynamic tongue base thickness in patients with obstructive sleep apnea. Ultrasound Med Biol. 2014 Nov;40(11):2590-8. doi: 10.1016/j.ultrasmedbio.2014.06.019. Epub 2014 Sep 12.
PMID: 25220277
citation: Lahav Y, Rosenzweig E, Heyman Z, Doljansky J, Green A, Dagan Y. Tongue base ultrasound: a diagnostic tool for predicting obstructive sleep apnea. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):179-84. doi: 10.1177/000348940911800304.
PMID: 19374148
citation: Liu KH, Chu WC, To KW, Ko FW, Tong MW, Chan JW, Hui DS. Sonographic measurement of lateral parapharyngeal wall thickness in patients with obstructive sleep apnea. Sleep. 2007 Nov;30(11):1503-8. doi: 10.1093/sleep/30.11.1503.
PMID: 18041482
citation: Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
PMID: 23675433
citation: Siegel H, Sonies BC, Graham B, McCutchen C, Hunter K, Vega-Bermudez F, Sato S. Obstructive sleep apnea: A study by simultaneous polysomnography and ultrasonic imaging. Neurology. 2000 May 9;54(9):1872. doi: 10.1212/wnl.54.9.1872. No abstract available.
PMID: 10802805
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Rakesh Sondekoppam Vijayashankar
investigator title: Principle Investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No