<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/NCT03276611</url>
  </required_header>
  <id_info>
    <org_study_id>17100139</org_study_id>
    <nct_id>NCT03276611</nct_id>
  </id_info>
  <brief_title>Assessment of Pulmonary Artery Pressure and Right Sided Hemodynamics in Patients With OSA Before and After CPAP TTT</brief_title>
  <official_title>Assessment of Pulmonary Artery Pressure and Right Sided Hemodynamics in Patients With OSA Before and After CPAP TTT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Obstructive sleep apnea (OSA) is a frequent sleep-related breathing disorder with an&#xD;
      incidence of 5-20% in the middle-aged population in Europe and Northern America . plumonary&#xD;
      hypertension is present in 12%-34% of patients with osa.continous positive air way pressureis&#xD;
      the main standard treatment ofOSA.Echocardiograghy is the most common non invasive imaging&#xD;
      method for assessment the effect on right ventricular function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) is a frequent sleep-related breathing disorder with an&#xD;
      incidence of 5-20% in the middle-aged population in Europe and Northern America .&#xD;
      Pathophysiologic consequences of OSA are increased sympathetic activity, hypoxia,&#xD;
      hypercapnia, increased left ventricular after-load , acute arterial hypertension, increased&#xD;
      diastolic and systolic pressure of the right ventricle, atrial dilation. Recent studies have&#xD;
      shown that OSA is an independent risk factor for cardiovascular mortality and morbidity. OSA&#xD;
      has a social impact because of fragmentation of sleep leads to increased daytime sleepiness,&#xD;
      decreased intellect, behavioral and personality changes, enuresis and sexual dysfunction.&#xD;
&#xD;
      Pulmonary hypertension is present in 12%-34% of patients with Obstructive Sleep Apnea&#xD;
      syndrome. When PH occurs as a consequence of OSA however symptoms may not be present because&#xD;
      of obesity and alack of physical exertion or symptoms of PH may be overlapped by other&#xD;
      cardiovascular abnormalities.&#xD;
&#xD;
      Continuous positive air way pressure therapy is the main standard treatment of OSA works the&#xD;
      best in the most people as positive pressure ventilation functions as a pneumatic splint for&#xD;
      the collapsing upper air way. Echocardiography is the most common non invasive imaging method&#xD;
      for assessment the effect of right ventricular function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 31, 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>Impact of OSA and CPAP therapy on pulmonary artery pressure and right sided hemodynamics</measure>
    <time_frame>Transthoracic echocardiography will be planned for evaluation of OSA patients regularly used CPAP (at least 5hrs/night) before and after 3 month of initiation of CPAP therapy.</time_frame>
    <description>Transthoracic echocardiography to determine right ventricle and right atrium functional parameters and dimensions and pulmonary artery systolic pressure, echocardiography will be planned for evaluation of OSA before initiation of CPAP therapy and after 3 month of CPAP therapy.</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Obstructive Sleep Apnea of Adult</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>echocardiograghy</intervention_name>
    <description>transthoracic echocardiograghy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients will be evaluated at the sleep lap of chest department of assiut university&#xD;
        hospital over 1 year will be enrolled in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate and severe OSA and candidates for initiation of CPAP therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant lung disease ,lfet sided heart failure,end stage malignancy and advanced&#xD;
             organ failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yahia Shabeeb, MBBCH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amr Youssef, MD</last_name>
    <phone>01006554042</phone>
    <email>amryoussef111@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hamdy ShamsEdeen, MD</last_name>
    <phone>01065601161</phone>
    <email>ashams98@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Amr Youssef</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amr Youssef, MD</last_name>
      <phone>01006554042</phone>
      <email>amryoussef111@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Hamdy ShamsEddin, MD</last_name>
      <phone>01065601161</phone>
      <email>Ashams98@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Park JG, Ramar K, Olson EJ. Updates on definition, consequences, and management of obstructive sleep apnea. Mayo Clin Proc. 2011 Jun;86(6):549-54; quiz 554-5. doi: 10.4065/mcp.2010.0810.</citation>
    <PMID>21628617</PMID>
  </reference>
  <reference>
    <citation>Gottdiener JS, Bednarz J, Devereux R, Gardin J, Klein A, Manning WJ, Morehead A, Kitzman D, Oh J, Quinones M, Schiller NB, Stein JH, Weissman NJ; American Society of Echocardiography. American Society of Echocardiography recommendations for use of echocardiography in clinical trials. J Am Soc Echocardiogr. 2004 Oct;17(10):1086-119. doi: 10.1016/j.echo.2004.07.013. No abstract available.</citation>
    <PMID>15452478</PMID>
  </reference>
  <reference>
    <citation>Kim SH, Cho GY, Shin C, Lim HE, Kim YH, Song WH, Shim WJ, Ahn JC. Impact of obstructive sleep apnea on left ventricular diastolic function. Am J Cardiol. 2008 Jun 1;101(11):1663-8. doi: 10.1016/j.amjcard.2008.01.056. Epub 2008 Apr 18.</citation>
    <PMID>18489948</PMID>
  </reference>
  <reference>
    <citation>Jurcut R, Giusca S, La Gerche A, Vasile S, Ginghina C, Voigt JU. The echocardiographic assessment of the right ventricle: what to do in 2010? Eur J Echocardiogr. 2010 Mar;11(2):81-96. doi: 10.1093/ejechocard/jep234. Epub 2010 Feb 2.</citation>
    <PMID>20124362</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Yahia Shabeeb Fadel Madi</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <keyword>Assessment</keyword>
  <keyword>pulmonary</keyword>
  <keyword>artery</keyword>
  <keyword>right</keyword>
  <keyword>sided</keyword>
  <keyword>hemodynamics</keyword>
  <keyword>patients</keyword>
  <keyword>sleep</keyword>
  <keyword>apnea</keyword>
  <keyword>syndrome</keyword>
  <keyword>contionous</keyword>
  <keyword>positive</keyword>
  <keyword>air</keyword>
  <keyword>way</keyword>
  <keyword>pressure</keyword>
  <keyword>treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>http://www.ncbi.nlm.nih.gov/</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03276611
org study id: 17100139
nct id: NCT03276611
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obstructive sleep apnea (OSA) is a frequent sleep-related breathing disorder with an
      incidence of 5-20% in the middle-aged population in Europe and Northern America . plumonary
      hypertension is present in 12%-34% of patients with osa.continous positive air way pressureis
      the main standard treatment ofOSA.Echocardiograghy is the most common non invasive imaging
      method for assessment the effect on right ventricular function.
Obstructive sleep apnea (OSA) is a frequent sleep-related breathing disorder with an
      incidence of 5-20% in the middle-aged population in Europe and Northern America .
      Pathophysiologic consequences of OSA are increased sympathetic activity, hypoxia,
      hypercapnia, increased left ventricular after-load , acute arterial hypertension, increased
      diastolic and systolic pressure of the right ventricle, atrial dilation. Recent studies have
      shown that OSA is an independent risk factor for cardiovascular mortality and morbidity. OSA
      has a social impact because of fragmentation of sleep leads to increased daytime sleepiness,
      decreased intellect, behavioral and personality changes, enuresis and sexual dysfunction.

      Pulmonary hypertension is present in 12%-34% of patients with Obstructive Sleep Apnea
      syndrome. When PH occurs as a consequence of OSA however symptoms may not be present because
      of obesity and alack of physical exertion or symptoms of PH may be overlapped by other
      cardiovascular abnormalities.

      Continuous positive air way pressure therapy is the main standard treatment of OSA works the
      best in the most people as positive pressure ventilation functions as a pneumatic splint for
      the collapsing upper air way. Echocardiography is the most common non invasive imaging method
      for assessment the effect of right ventricular function.
observational model: Cohort
time perspective: Prospective
measure: Impact of OSA and CPAP therapy on pulmonary artery pressure and right sided hemodynamics
time frame: Transthoracic echocardiography will be planned for evaluation of OSA patients regularly used CPAP (at least 5hrs/night) before and after 3 month of initiation of CPAP therapy.
description: Transthoracic echocardiography to determine right ventricle and right atrium functional parameters and dimensions and pulmonary artery systolic pressure, echocardiography will be planned for evaluation of OSA before initiation of CPAP therapy and after 3 month of CPAP therapy.
intervention type: Other
intervention name: echocardiograghy
description: transthoracic echocardiograghy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yahia Shabeeb, MBBCH
role: Principal Investigator
affiliation: Assiut University
last name: Amr Youssef, MD
phone: 01006554042
email: amryoussef111@yahoo.com
last name: Hamdy ShamsEdeen, MD
phone: 01065601161
email: ashams98@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
citation: Park JG, Ramar K, Olson EJ. Updates on definition, consequences, and management of obstructive sleep apnea. Mayo Clin Proc. 2011 Jun;86(6):549-54; quiz 554-5. doi: 10.4065/mcp.2010.0810.
PMID: 21628617
citation: Gottdiener JS, Bednarz J, Devereux R, Gardin J, Klein A, Manning WJ, Morehead A, Kitzman D, Oh J, Quinones M, Schiller NB, Stein JH, Weissman NJ; American Society of Echocardiography. American Society of Echocardiography recommendations for use of echocardiography in clinical trials. J Am Soc Echocardiogr. 2004 Oct;17(10):1086-119. doi: 10.1016/j.echo.2004.07.013. No abstract available.
PMID: 15452478
citation: Kim SH, Cho GY, Shin C, Lim HE, Kim YH, Song WH, Shim WJ, Ahn JC. Impact of obstructive sleep apnea on left ventricular diastolic function. Am J Cardiol. 2008 Jun 1;101(11):1663-8. doi: 10.1016/j.amjcard.2008.01.056. Epub 2008 Apr 18.
PMID: 18489948
citation: Jurcut R, Giusca S, La Gerche A, Vasile S, Ginghina C, Voigt JU. The echocardiographic assessment of the right ventricle: what to do in 2010? Eur J Echocardiogr. 2010 Mar;11(2):81-96. doi: 10.1093/ejechocard/jep234. Epub 2010 Feb 2.
PMID: 20124362
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Yahia Shabeeb Fadel Madi
investigator title: principle investigator
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided
study doc: 