<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/NCT02969551</url>
  </required_header>
  <id_info>
    <org_study_id>88/14</org_study_id>
    <nct_id>NCT02969551</nct_id>
  </id_info>
  <brief_title>Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE</brief_title>
  <official_title>Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of&#xD;
      sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not&#xD;
      eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE).&#xD;
      The frequency and obstructions patterns in different sleep stages are assessed. In addition&#xD;
      obstruction patterns detected with AG are compared with DISE examination in the selected&#xD;
      cases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Detection of obstruction depending of sleep stage</measure>
    <time_frame>8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparing the manometry findings to DISE</measure>
    <time_frame>1 Hour</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Sleep Apnea Syndromes</condition>
  <arm_group>
    <arm_group_label>Sleep apnea, Manometry and possibly DISE</arm_group_label>
    <description>Sleep apnea Patients recieved manometry measures and those who were not considered for CPAP Therapy recieved Drug induced sleep endoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manometry and possibly DISE</intervention_name>
    <description>A Manometry is performed on all patients. After it in some Patient DISE is followed</description>
    <arm_group_label>Sleep apnea, Manometry and possibly DISE</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with a diagnosed obstructive sleep apnea Syndrome.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apnea-Hypopnea-Index (AHI) ≥ 5.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years;&#xD;
&#xD;
          -  body mass index (BMI) of &gt;35 kg/m2; active infection;&#xD;
&#xD;
          -  previous oral, head, or neck surgery in the last 3 months; pregnancy; chronic use of&#xD;
             alcohol (&gt; 60g ethanol per day or &gt; 150g ethanol per week) or sedatives; illicit drug&#xD;
             use;&#xD;
&#xD;
          -  chronic obstructive pulmonary disease.&#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_official>
    <last_name>Clemens Heiser, MD</last_name>
    <role>Study Chair</role>
    <affiliation>attending doctor in ENT</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clemens Heiser, MD</last_name>
    <phone>+49 8941409583</phone>
    <email>hno@heiser-online.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Günther M Edenharter, MD</last_name>
    <phone>+49 89 41405051</phone>
    <email>g.edenharter@tum.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinik für Hals- Nasen- Ohrenheilkunde</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clemens Heiser, MD</last_name>
      <phone>+49 89 41409583</phone>
      <email>hno@heiser-online.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>March 16, 2017</last_update_submitted>
  <last_update_submitted_qc>March 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Airway Obstruction</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/NCT02969551
org study id: 88/14
nct id: NCT02969551
lead sponsor: 
has dmc: No
Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of
      sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not
      eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE).
      The frequency and obstructions patterns in different sleep stages are assessed. In addition
      obstruction patterns detected with AG are compared with DISE examination in the selected
      cases.
observational model: Cohort
time perspective: Prospective
measure: Detection of obstruction depending of sleep stage
time frame: 8
measure: Comparing the manometry findings to DISE
time frame: 1 Hour
arm group label: Sleep apnea, Manometry and possibly DISE
description: Sleep apnea Patients recieved manometry measures and those who were not considered for CPAP Therapy recieved Drug induced sleep endoscopy.
intervention type: Device
intervention name: Manometry and possibly DISE
description: A Manometry is performed on all patients. After it in some Patient DISE is followed
arm group label: Sleep apnea, Manometry and possibly DISE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clemens Heiser, MD
role: Study Chair
affiliation: attending doctor in ENT
last name: Clemens Heiser, MD
phone: +49 8941409583
email: hno@heiser-online.com
last name: Günther M Edenharter, MD
phone: +49 89 41405051
email: g.edenharter@tum.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Airway Obstruction
sharing ipd: No