<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/NCT03832244</url>
  </required_header>
  <id_info>
    <org_study_id>BartinUyku</org_study_id>
    <nct_id>NCT03832244</nct_id>
  </id_info>
  <brief_title>The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales</brief_title>
  <official_title>The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bartin State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bartin State Hospital</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>
      The investigators hypothesize that sub-mental ultrasonography measures are strongly&#xD;
      correlated with the severity of Obstructive Sleep Apnea Syndrome and the related specific&#xD;
      subjective scales.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Polysomnography (PSG) is the gold-standard diagnose tool for Obstructive Sleep Apnea (OSA).&#xD;
      However, the availability of PSG is limited, particularly in developing and / or least&#xD;
      developed countries. Sub-mental ultrasonography is stepped forward with its practical and&#xD;
      cheap nature and its widespread use.&#xD;
&#xD;
      The investigators aimed to perform sub-mental ultrasonography to the patients who underwent&#xD;
      to PSG by a blind-to-the-PSG-results radiologist and analyse the correlation between&#xD;
      ultrasound measures, Apnea-Hypopnea Index (measured by Polysomnography) and subjective OSA&#xD;
      scales.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 22, 2019</start_date>
  <completion_date type="Actual">January 24, 2021</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tongue base thickness</measure>
    <time_frame>Baseline</time_frame>
    <description>The closest distance between tongue base and the skin in the sagittal plane</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retropalatal distance</measure>
    <time_frame>Baseline</time_frame>
    <description>The diameter of retropalatal space in the transverse dimension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance between lingual arteries</measure>
    <time_frame>Baseline</time_frame>
    <description>Distance between lingual arteries in the transverse plane</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stop-Bang questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI &gt; 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berlin Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>The questionnaire consists of 3 categories related to the risk of having sleep apnea.&#xD;
Category 1 is positive if the total score is 2 or more points. Category 2 is positive if the total score is 2 or more points. Category 3 is positive if the answer to item 10 is 'Yes' or if the BMI of the patient is greater than 30kg/m2. (BMI is defined as weight (kg) divided by height (m) squared, i.e.., kg/m2). Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive. Total score is ranged between 0-3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Baseline</time_frame>
    <description>The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck circumference</measure>
    <time_frame>Baseline</time_frame>
    <description>Neck circumference was measured with the head erect and eyes facing forward, horizontally at the upper margin of the thyroid cartilage (to the nearest 0.1 cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The thyromental distance</measure>
    <time_frame>Baseline</time_frame>
    <description>The thyromental distance is defined as the distance from the chin (mentum) to the top of the notch of the thyroid cartilage with the head fully extended. It is measured with a ruler</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">199</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Diagnostic Imaging</condition>
  <condition>Ultrasound</condition>
  <arm_group>
    <arm_group_label>Simple snoring</arm_group_label>
    <description>Patients undergoing to Sub-mental ultrasonography with Normal sleep: Fewer than 5 events per hour measured in over-night polysomnography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild OSA</arm_group_label>
    <description>Patients undergoing to Sub-mental ultrasonography with Mild sleep apnea: 5 to 14 events per hour measured in over-night polysomnography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate OSA</arm_group_label>
    <description>Patients undergoing to Sub-mental ultrasonography with Moderate sleep apnea: 15 to 29 events per hour measured in over-night polysomnography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe OSA</arm_group_label>
    <description>Patients undergoing to Sub-mental ultrasonography with Severe sleep apnea: 30 or more events per hour measured in over-night polysomnography</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sub-mental ultrasonography</intervention_name>
    <description>Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries</description>
    <arm_group_label>Mild OSA</arm_group_label>
    <arm_group_label>Moderate OSA</arm_group_label>
    <arm_group_label>Severe OSA</arm_group_label>
    <arm_group_label>Simple snoring</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  For study group: Patients who have been diagnosed as having obstructive sleep apnea on&#xD;
             polysomnography&#xD;
&#xD;
          -  For control group: Patients who have a negative polysomnography or normal scores from&#xD;
             subjective scales&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who consented for sub-mental ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any pharyngo laryngeal anatomic abnormality&#xD;
&#xD;
          -  Previous history of Obstructive sleep apnea treatment&#xD;
&#xD;
          -  Previous history of surgical intervention to the pharyngo laryngeal anatomic area&#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>Ozge Yagcioglu Yassa, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Coordinator of Sleep Disorders Centre of Bartin State Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bartin State Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_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>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>January 24, 2021</last_update_submitted>
  <last_update_submitted_qc>January 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bartin State Hospital</investigator_affiliation>
    <investigator_full_name>Ozgeyagcioglu Yassa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sub-mental ultrasonography</keyword>
  <keyword>obstructive 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>
  <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/NCT03832244
org study id: BartinUyku
nct id: NCT03832244
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that sub-mental ultrasonography measures are strongly
      correlated with the severity of Obstructive Sleep Apnea Syndrome and the related specific
      subjective scales.
Polysomnography (PSG) is the gold-standard diagnose tool for Obstructive Sleep Apnea (OSA).
      However, the availability of PSG is limited, particularly in developing and / or least
      developed countries. Sub-mental ultrasonography is stepped forward with its practical and
      cheap nature and its widespread use.

      The investigators aimed to perform sub-mental ultrasonography to the patients who underwent
      to PSG by a blind-to-the-PSG-results radiologist and analyse the correlation between
      ultrasound measures, Apnea-Hypopnea Index (measured by Polysomnography) and subjective OSA
      scales.
observational model: Cohort
time perspective: Cross-Sectional
measure: Tongue base thickness
time frame: Baseline
description: The closest distance between tongue base and the skin in the sagittal plane
measure: Retropalatal distance
time frame: Baseline
description: The diameter of retropalatal space in the transverse dimension
measure: Distance between lingual arteries
time frame: Baseline
description: Distance between lingual arteries in the transverse plane
measure: Stop-Bang questionnaire
time frame: Baseline
description: This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.
measure: Berlin Questionnaire
time frame: Baseline
description: The questionnaire consists of 3 categories related to the risk of having sleep apnea.
Category 1 is positive if the total score is 2 or more points. Category 2 is positive if the total score is 2 or more points. Category 3 is positive if the answer to item 10 is 'Yes' or if the BMI of the patient is greater than 30kg/m2. (BMI is defined as weight (kg) divided by height (m) squared, i.e.., kg/m2). Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive. Total score is ranged between 0-3.
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: Baseline
description: The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
measure: Neck circumference
time frame: Baseline
description: Neck circumference was measured with the head erect and eyes facing forward, horizontally at the upper margin of the thyroid cartilage (to the nearest 0.1 cm)
measure: The thyromental distance
time frame: Baseline
description: The thyromental distance is defined as the distance from the chin (mentum) to the top of the notch of the thyroid cartilage with the head fully extended. It is measured with a ruler
arm group label: Simple snoring
description: Patients undergoing to Sub-mental ultrasonography with Normal sleep: Fewer than 5 events per hour measured in over-night polysomnography
arm group label: Mild OSA
description: Patients undergoing to Sub-mental ultrasonography with Mild sleep apnea: 5 to 14 events per hour measured in over-night polysomnography
arm group label: Moderate OSA
description: Patients undergoing to Sub-mental ultrasonography with Moderate sleep apnea: 15 to 29 events per hour measured in over-night polysomnography
arm group label: Severe OSA
description: Patients undergoing to Sub-mental ultrasonography with Severe sleep apnea: 30 or more events per hour measured in over-night polysomnography
intervention type: Diagnostic Test
intervention name: Sub-mental ultrasonography
description: Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries
arm group label: Mild OSA
arm group label: Moderate OSA
arm group label: Severe OSA
arm group label: Simple snoring
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ozge Yagcioglu Yassa, M.D.
role: Principal Investigator
affiliation: Coordinator of Sleep Disorders Centre of Bartin State Hospital
facility: 
country: Turkey
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
responsible party type: Principal Investigator
investigator affiliation: Bartin State Hospital
investigator full name: Ozgeyagcioglu Yassa
investigator title: Principal Investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No