<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/NCT01687855</url>
  </required_header>
  <id_info>
    <org_study_id>wzmcwyl</org_study_id>
    <secondary_id>0577325</secondary_id>
    <nct_id>NCT01687855</nct_id>
  </id_info>
  <brief_title>Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep</brief_title>
  <official_title>Observation of the Change in Soft Tissue in OSAH</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the dynamic changes of the tongue in patients with&#xD;
      obstructive sleep apnoea hypopnea syndrome (OSAHS) during sleep and while awake by using&#xD;
      Ultrafast Magnetic Resonance Imaging (UMRI)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      UMRI was undertaken on the upper airway in 21 OSAHS patients and 20 normal people after being&#xD;
      deprived of sleep for one night. A series of midline sagittal images of the upper airway were&#xD;
      obtained. The dynamic alterations of the tongue size and the distance from the tongue to X&#xD;
      axis (an extended line from the anterior nasal spine to posterior nasal spine) and Y axis (a&#xD;
      perpendicular line from the center of the pituitary to the X axis) were measured.Statistical&#xD;
      comparisons between pairs of means were performed via t-tests using Spss10 software. A&#xD;
      probability level of p&lt;0.05 was considered to be statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2003</start_date>
  <completion_date type="Actual">May 2006</completion_date>
  <primary_completion_date type="Actual">May 2006</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the distance from the tongue to X axis and Y axis</measure>
    <time_frame>one night</time_frame>
    <description>X axis is an extended line from the anterior nasal spine to posterior nasal spine ； Y axis is a perpendicular line from the center of the pituitary to the X axis；</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the tongue size</measure>
    <time_frame>one night</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Obstructive Sleep Apnoea</condition>
  <arm_group>
    <arm_group_label>OSAHS group</arm_group_label>
    <description>Subjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal group</arm_group_label>
    <description>Subjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrafast Magnetic Resonance Imaging</intervention_name>
    <description>MRI was performed with a 1.5 superconducting magnet (Gyroscan Intera type, Philips Co. Holland) in a posterior and anterior neck coil. The sequence used to perform the ultrafast MRI was a fast gradient- echo plus sequence. Technical parameters included: echo time, 12 msec; repetition time, 2.3 msec; flap angle, 250; matrix, 192 × 512; section thickness, 7 mm. The imaging time per slice for this sequence was 0.92 sec. A total of 120 consecutive images were obtained as a single section, with a total imaging time of 110.4 seconds. MRI scanning was carried out with the subject first asleep, then whilst awake after 20 minutes in quiet respiration. All images were inputted to the PACS workstation.</description>
    <arm_group_label>OSAHS group</arm_group_label>
    <arm_group_label>normal group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects are recruited prospectively from the Tenth Hospital Affiliated to Tongji&#xD;
        University of Shanghai,with varying degrees of symptoms of OSAHS (daytime sleepiness,&#xD;
        snoring and/or nocturnal apneas).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients who are male&#xD;
&#xD;
          2. patients were diagnosed as OSAHS&#xD;
&#xD;
          3. patients underwent a thorough history (including the Epworth somnolence questionnaire)&#xD;
             and physical examination&#xD;
&#xD;
          4. patients did not undergo any treatment&#xD;
&#xD;
          5. each subject gave written informed consent before entering the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients didn't sign written informed consent&#xD;
&#xD;
          2. Any situation or condition that will interfere with adherence to study activities&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rong D Hu, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Wenzhou Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Tenth Hospital Affiliated to Tongji University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.nlm.nih.gov/medlineplus/</url>
    <description>Sleep Apnea</description>
  </link>
  <reference>
    <citation>Horner RL, Innes JA, Morrell MJ, Shea SA, Guz A. The effect of sleep on reflex genioglossus muscle activation by stimuli of negative airway pressure in humans. J Physiol. 1994 Apr 1;476(1):141-51.</citation>
    <PMID>8046629</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>RongD Hu</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Obstructive Sleep</keyword>
  <keyword>Apnoea</keyword>
  <keyword>tongue</keyword>
  <keyword>alteration</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/NCT01687855
org study id: wzmcwyl
secondary id: 0577325
nct id: NCT01687855
lead sponsor: 
has dmc: Yes
The aim of this study was to evaluate the dynamic changes of the tongue in patients with
      obstructive sleep apnoea hypopnea syndrome (OSAHS) during sleep and while awake by using
      Ultrafast Magnetic Resonance Imaging (UMRI)
UMRI was undertaken on the upper airway in 21 OSAHS patients and 20 normal people after being
      deprived of sleep for one night. A series of midline sagittal images of the upper airway were
      obtained. The dynamic alterations of the tongue size and the distance from the tongue to X
      axis (an extended line from the anterior nasal spine to posterior nasal spine) and Y axis (a
      perpendicular line from the center of the pituitary to the X axis) were measured.Statistical
      comparisons between pairs of means were performed via t-tests using Spss10 software. A
      probability level of p<0.05 was considered to be statistically significant.
observational model: Case-Control
time perspective: Prospective
measure: the distance from the tongue to X axis and Y axis
time frame: one night
description: X axis is an extended line from the anterior nasal spine to posterior nasal spine ； Y axis is a perpendicular line from the center of the pituitary to the X axis；
measure: the tongue size
time frame: one night
arm group label: OSAHS group
description: Subjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway .
arm group label: normal group
description: Subjects that underwent night Ultrafast Magnetic Resonance Imaging with obtaining a series of midline sagittal images of the upper airway .
intervention type: Device
intervention name: Ultrafast Magnetic Resonance Imaging
description: MRI was performed with a 1.5 superconducting magnet (Gyroscan Intera type, Philips Co. Holland) in a posterior and anterior neck coil. The sequence used to perform the ultrafast MRI was a fast gradient- echo plus sequence. Technical parameters included: echo time, 12 msec; repetition time, 2.3 msec; flap angle, 250; matrix, 192 × 512; section thickness, 7 mm. The imaging time per slice for this sequence was 0.92 sec. A total of 120 consecutive images were obtained as a single section, with a total imaging time of 110.4 seconds. MRI scanning was carried out with the subject first asleep, then whilst awake after 20 minutes in quiet respiration. All images were inputted to the PACS workstation.
arm group label: OSAHS group
arm group label: normal group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rong D Hu, Ph.D
role: Study Chair
affiliation: Wenzhou Medical University
facility: 
country: China
url: http://www.nlm.nih.gov/medlineplus/
description: Sleep Apnea
citation: Horner RL, Innes JA, Morrell MJ, Shea SA, Guz A. The effect of sleep on reflex genioglossus muscle activation by stimuli of negative airway pressure in humans. J Physiol. 1994 Apr 1;476(1):141-51.
PMID: 8046629
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: RongD Hu
investigator title: principal investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive