<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/NCT03257488</url>
  </required_header>
  <id_info>
    <org_study_id>163/2014/O/Disp</org_study_id>
    <nct_id>NCT03257488</nct_id>
  </id_info>
  <brief_title>Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study</brief_title>
  <official_title>Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive&#xD;
      sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial&#xD;
      hypertension. Results are compared with a modified portable sleep apnea testing (type III&#xD;
      portable monitoring: Somnocheck 2 Weinmann).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OSAS is a syndrome characterized by the partial or total collapse of the high airways which&#xD;
      determines snore, airflow limitation, hypopnea and apnea.These events cause desaturations,&#xD;
      daytime sleepiness and an increased risk of cardio and cerebral vascular diseases.&#xD;
&#xD;
      OSAS's prevalence is estimated between 64-83% among patients affected by resistant arterial&#xD;
      hypertension; therefore OSAS's screening is mandatory during the clinical work-up of these&#xD;
      patients.&#xD;
&#xD;
      This study is a randomized, interventional, spontaneous, exploratory, cross-over and&#xD;
      monocentric trial, which assesses the utility and reliability of the reduced&#xD;
      cardio-respiratory monitoring (type IV portable monitoring: Somnocheck micro Weinmann) to&#xD;
      estimate the prevalence of OSAS among patients affected by resistant systemic arterial&#xD;
      hypertension. The results are compared with a complete cardio-respiratory monitoring (type&#xD;
      III portable monitoring: Somnocheck 2 Weinmann).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2015</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.</measure>
    <time_frame>These two procedures must be done in the same patient within 5 days</time_frame>
    <description>Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with cardiovascular abnormalities 1</measure>
    <time_frame>Cardiovascular assessment must be done within 6 months before the sleep studies.</time_frame>
    <description>Number of Participants with cardiovascular abnormalities assessed by arterial blood pressure monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with cardiovascular abnormalities 2</measure>
    <time_frame>Cardiovascular assessment must be done within 6 months before the sleep studies.</time_frame>
    <description>Number of Participants with cardiovascular abnormalities assessed by ecocardiography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>Resistant Hypertension</condition>
  <arm_group>
    <arm_group_label>Screening device-Traditional device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients included in the A Group will be studied during the first night with the screening device (type IV portable monitoring Somnocheck micro Weinmann) and with the traditional one during the following night.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional device-Screening device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients included in the B Group will be studied during the first night with the traditional device and with the screening one (type IV portable monitoring Somnocheck micro Weinmann) during the following night.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>type IV portable monitoring (Somnocheck micro Weinmann)</intervention_name>
    <description>Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea.</description>
    <arm_group_label>Screening device-Traditional device</arm_group_label>
    <arm_group_label>Traditional device-Screening device</arm_group_label>
    <other_name>type III portable monitoring (Somnocheck 2 Weinmann)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resistant Arterial Hypertension&#xD;
&#xD;
          -  Patients must sign the informed consent&#xD;
&#xD;
        Exclusion Criteria: ,&#xD;
&#xD;
          -  atrial fibrillation with haemodynamic instability&#xD;
&#xD;
          -  congestive hearth failure,&#xD;
&#xD;
          -  BMI&gt;45 kg/m2,&#xD;
&#xD;
          -  respiratory failure&#xD;
&#xD;
          -  renal or liver failure,&#xD;
&#xD;
          -  stroke,&#xD;
&#xD;
          -  implantable cardioverter-defibrillator (ICD),&#xD;
&#xD;
          -  pacemaker (PM),&#xD;
&#xD;
          -  previous diagnosis of OSAS,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  breastfeeding,&#xD;
&#xD;
          -  patients must not be already enrolled in other clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Francesco Tavalazzi, Medical</last_name>
    <phone>+390512143253</phone>
    <email>francesco.tavalazzi@aosp.bo.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda ospedaliera policlinico Sant'Orsola-Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Tavalazzi, medical</last_name>
      <phone>+300512143252</phone>
      <email>francesco.tavalazzi@aosp.bo.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>February 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Francesco Tavalazzi</investigator_full_name>
    <investigator_title>Medical Doctor</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>
    <mesh_term>Hypertension</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/NCT03257488
org study id: 163/2014/O/Disp
nct id: NCT03257488
lead sponsor: 
has dmc: Yes
This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive
      sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial
      hypertension. Results are compared with a modified portable sleep apnea testing (type III
      portable monitoring: Somnocheck 2 Weinmann).
OSAS is a syndrome characterized by the partial or total collapse of the high airways which
      determines snore, airflow limitation, hypopnea and apnea.These events cause desaturations,
      daytime sleepiness and an increased risk of cardio and cerebral vascular diseases.

      OSAS's prevalence is estimated between 64-83% among patients affected by resistant arterial
      hypertension; therefore OSAS's screening is mandatory during the clinical work-up of these
      patients.

      This study is a randomized, interventional, spontaneous, exploratory, cross-over and
      monocentric trial, which assesses the utility and reliability of the reduced
      cardio-respiratory monitoring (type IV portable monitoring: Somnocheck micro Weinmann) to
      estimate the prevalence of OSAS among patients affected by resistant systemic arterial
      hypertension. The results are compared with a complete cardio-respiratory monitoring (type
      III portable monitoring: Somnocheck 2 Weinmann).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
time frame: These two procedures must be done in the same patient within 5 days
description: Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
measure: Number of Participants with cardiovascular abnormalities 1
time frame: Cardiovascular assessment must be done within 6 months before the sleep studies.
description: Number of Participants with cardiovascular abnormalities assessed by arterial blood pressure monitoring
measure: Number of Participants with cardiovascular abnormalities 2
time frame: Cardiovascular assessment must be done within 6 months before the sleep studies.
description: Number of Participants with cardiovascular abnormalities assessed by ecocardiography
arm group label: Screening device-Traditional device
arm group type: Active Comparator
description: The patients included in the A Group will be studied during the first night with the screening device (type IV portable monitoring Somnocheck micro Weinmann) and with the traditional one during the following night.
arm group label: Traditional device-Screening device
arm group type: Active Comparator
description: The patients included in the B Group will be studied during the first night with the traditional device and with the screening one (type IV portable monitoring Somnocheck micro Weinmann) during the following night.
intervention type: Device
intervention name: type IV portable monitoring (Somnocheck micro Weinmann)
description: Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea.
arm group label: Screening device-Traditional device
arm group label: Traditional device-Screening device
other name: type III portable monitoring (Somnocheck 2 Weinmann)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francesco Tavalazzi, Medical
phone: +390512143253
email: francesco.tavalazzi@aosp.bo.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Francesco Tavalazzi
investigator title: Medical Doctor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Hypertension