<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/NCT02207127</url>
  </required_header>
  <id_info>
    <org_study_id>HS-14-00101</org_study_id>
    <nct_id>NCT02207127</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging in Obstructive Sleep Apnea</brief_title>
  <acronym>MRI in OSA</acronym>
  <official_title>Magnetic Resonance Imaging in Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a fundamental gap in the investigators ability to design effective surgical&#xD;
      treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate&#xD;
      non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful&#xD;
      outcome ranging from 5% to 65% for individual or combination procedures. To predict - and&#xD;
      thereby to improve - outcomes, the investigators must determine what predicts surgical&#xD;
      success. This project will compare findings from two evaluations: drug-induced sleep&#xD;
      endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated&#xD;
      important benefits, but it has important limitations. Upper airway MRI is the most complete&#xD;
      evaluation performed during wakefulness, making it conducive to broad application and less&#xD;
      expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. The&#xD;
      investigators propose a cross-sectional analysis of 40 adult subjects with moderate to severe&#xD;
      OSA. In addition to history, physical examination, and polysomnogram (sleep study), all&#xD;
      subjects will undergo DISE and MRI to characterize the pattern of obstruction. The&#xD;
      investigators will examine the association between DISE and MRI, focusing on specific DISE&#xD;
      findings that have been associated with surgical outcomes. The investigators&#xD;
      multidisciplinary team has substantial expertise and experience in OSA investigation, DISE,&#xD;
      and upper airway MRI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to refine study measurements/protocol adequately.&#xD;
  </why_stopped>
  <start_date type="Actual">May 8, 2023</start_date>
  <completion_date type="Actual">May 8, 2023</completion_date>
  <primary_completion_date type="Actual">May 8, 2023</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>Surgical results</measure>
    <time_frame>6 months</time_frame>
    <description>Surgical outcomes will be measured using sleep study outcomes (apnea-hypopnea index). The analysis will include evaluation of a potential association between surgical outcomes and both MRI and DISE measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep-Related Quality of Life</measure>
    <time_frame>6 months</time_frame>
    <description>Sleep-related quality of life will be assessed with the Functional Outcomes of Sleep Questionnaire. Changes will be determined by a comparison of preoperative and postoperative scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daytime Sleepiness</measure>
    <time_frame>6 months</time_frame>
    <description>Daytime sleepiness will be assessed with the Epworth Sleepiness Scale score. Changes will be determined by a comparison of preoperative and postoperative scores.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>MRI, DISE, and Surgery</arm_group_label>
    <description>All participants will undergo MRI and DISE prior to undergoing surgical treatment of obstructive sleep apnea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI, DISE, and Surgery</intervention_name>
    <description>MRI, DISE, and Surgery</description>
    <arm_group_label>MRI, DISE, and Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study participants will be adults with obstructive sleep apnea undergoing surgery. All&#xD;
        participants will undergo magnetic resonance imaging (MRI) and drug-induced sleep endoscopy&#xD;
        (DISE).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 21 years; moderate to severe OSA (AHI ≥15 events/hour)&#xD;
&#xD;
          -  body mass index &lt;40 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior OSA surgery&#xD;
&#xD;
          -  known neurologic, cardiac, pulmonary, renal, or hepatic disorders&#xD;
&#xD;
          -  psychiatric problems except for treated depression or mild anxiety&#xD;
&#xD;
          -  co-existing sleep disorder other than OSA&#xD;
&#xD;
          -  other contraindication to DISE or MRI such as propofol allergy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Keck Hospital of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obstructive sleep apnea</keyword>
  <keyword>sleep apnea</keyword>
  <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>
  <!-- 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/NCT02207127
org study id: HS-14-00101
nct id: NCT02207127
lead sponsor: 
collaborator: 
has dmc: No
There is a fundamental gap in the investigators ability to design effective surgical
      treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate
      non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful
      outcome ranging from 5% to 65% for individual or combination procedures. To predict - and
      thereby to improve - outcomes, the investigators must determine what predicts surgical
      success. This project will compare findings from two evaluations: drug-induced sleep
      endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated
      important benefits, but it has important limitations. Upper airway MRI is the most complete
      evaluation performed during wakefulness, making it conducive to broad application and less
      expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. The
      investigators propose a cross-sectional analysis of 40 adult subjects with moderate to severe
      OSA. In addition to history, physical examination, and polysomnogram (sleep study), all
      subjects will undergo DISE and MRI to characterize the pattern of obstruction. The
      investigators will examine the association between DISE and MRI, focusing on specific DISE
      findings that have been associated with surgical outcomes. The investigators
      multidisciplinary team has substantial expertise and experience in OSA investigation, DISE,
      and upper airway MRI.
observational model: Cohort
time perspective: Prospective
measure: Surgical results
time frame: 6 months
description: Surgical outcomes will be measured using sleep study outcomes (apnea-hypopnea index). The analysis will include evaluation of a potential association between surgical outcomes and both MRI and DISE measures.
measure: Sleep-Related Quality of Life
time frame: 6 months
description: Sleep-related quality of life will be assessed with the Functional Outcomes of Sleep Questionnaire. Changes will be determined by a comparison of preoperative and postoperative scores.
measure: Daytime Sleepiness
time frame: 6 months
description: Daytime sleepiness will be assessed with the Epworth Sleepiness Scale score. Changes will be determined by a comparison of preoperative and postoperative scores.
arm group label: MRI, DISE, and Surgery
description: All participants will undergo MRI and DISE prior to undergoing surgical treatment of obstructive sleep apnea.
intervention type: Procedure
intervention name: MRI, DISE, and Surgery
description: MRI, DISE, and Surgery
arm group label: MRI, DISE, and Surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive