<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/NCT01685736</url>
  </required_header>
  <id_info>
    <org_study_id>OSA</org_study_id>
    <nct_id>NCT01685736</nct_id>
  </id_info>
  <brief_title>Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea</brief_title>
  <acronym>OSA</acronym>
  <official_title>Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Athens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements,&#xD;
      24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that&#xD;
      allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3&#xD;
      nights, 3 readings/night).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</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>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Obstructive Sleep Apnoea</condition>
  <condition>Hypertension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects referred to a sleep clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≤ 65 years&#xD;
&#xD;
          -  Suspected OSA&#xD;
&#xD;
          -  Treated or untreated for hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiovascular disease (heart failure, coronary heart disease, arrhythmia&#xD;
             or stroke)&#xD;
&#xD;
          -  History of asthma or chronic obstructive pulmonary disease (FEV1/FVC &lt;70%)&#xD;
&#xD;
          -  History of diabetes mellitus, collagen diseases and sarcoidosis&#xD;
&#xD;
          -  Serum creatinine &gt;1.6 mg/dl, proteinuria&#xD;
&#xD;
          -  Previous treatment with CPAP&#xD;
&#xD;
          -  Pregnancy or menstruation during the study&#xD;
&#xD;
          -  Treatment with steroids, lithium or any other drugs affecting BP&#xD;
&#xD;
          -  Change in antihypertensive treatment(if any) in the last 8 weeks before study entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>First University Department of Respiratory Medicine, Sotiria Hospital</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manos Alchanatis, Assoc. Prof. Respir. Medicine</last_name>
      <phone>+302107763685</phone>
    </contact>
    <investigator>
      <last_name>Manos Alchanatis, Assoc. Prof. Respir. Medicine</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hypertension Center, Third Department of Medicine, University of Athens, Greece</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>George S Stergiou, MD</last_name>
      <phone>+302107763117</phone>
      <email>gstergi@med.uoa.gr</email>
    </contact>
    <investigator>
      <last_name>George S Stergiou, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Athens</investigator_affiliation>
    <investigator_full_name>George S. Stergiou</investigator_full_name>
    <investigator_title>Associate Professor of Medicine and Hypertension</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>
  <!-- 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/NCT01685736
org study id: OSA
nct id: NCT01685736
lead sponsor: 
has dmc: No
Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements,
      24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that
      allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3
      nights, 3 readings/night).
observational model: Case-Only
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Athens
investigator full name: George S. Stergiou
investigator title: Associate Professor of Medicine and Hypertension
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive