<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/NCT01690429</url>
  </required_header>
  <id_info>
    <org_study_id>SOMNOcheck-2012</org_study_id>
    <nct_id>NCT01690429</nct_id>
  </id_info>
  <brief_title>Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea</brief_title>
  <official_title>Arousalanalyse Mittels Pulswellenamplitude Bei Patienten Mit Obstruktiver Schlafapnoe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut für Pneumologie Hagen Ambrock eV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weinmann Geräte für Medizin GmbH + Co. KG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut für Pneumologie Hagen Ambrock eV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA)&#xD;
      from a finger. This can be measured using the Somnocheck micro system. A pulse wave amplitude&#xD;
      decrease (PWAD) is considered to be a marker for autonomic activation. Detecting the PWAD is&#xD;
      a surrogate marker for waking reactions (arousal) which eventually will contribute to assess&#xD;
      sleep disruption and resulting performance deterioration. Arousal and performance&#xD;
      deterioration and its possible improvement under continuous positive airway pressure (CPAP)&#xD;
      therapy will be determined in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients from the sleep laboratory with verified obstructive sleep apnea syndrome (OSAS) will&#xD;
      be asked to participate in this study.&#xD;
&#xD;
      A device is used to determine autonomic arousal over night (SOMNOcheck micro). The Somnocheck&#xD;
      micro records oxygen saturation as well as pulse frequency and breathing, and calculates an&#xD;
      autonomic arousal index (AAI). Somnocheck measurements will take place in two nights&#xD;
      (baseline and with CPAP) and parallel to a standard polysomnography (PSG). The PSG provides&#xD;
      data to analyze the arousal frequency according to ASDA rules, which will then be compared to&#xD;
      the AAI.&#xD;
&#xD;
      Performance is determined twice (prior and after CPAP therapy) by the use of a steering&#xD;
      simulator programme (DASS). Differences in arousal will be correlated with differences in&#xD;
      performance (deviation from the road, reaction time). The subjects are also asked to fill out&#xD;
      the Epworth Sleepiness Scale (ESS) twice, prior and after therapy. Aim is to compare&#xD;
      Somnocheck and PSG measurements and daytime sleepiness with DASS and ESS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pulse wave amplitude (PWA)</measure>
    <time_frame>8 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>OSA Patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Somnocheck micro</intervention_name>
    <description>Study nights in sleep lab with standard polysomnography plus Somnocheck micro. The Somnocheck micro is a device with pulse oxymetry and nasal cannula, which can be worn like a wristwatch. It records information about sleep disordered breathing, oxygen saturation, and pulse wave.</description>
    <arm_group_label>OSA Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obstructive Sleep Apnea (AHI &gt;5)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected acute cardiac, pulmonary or neurologic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karl Heinz Rühle, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helios Klinik Hagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helios Klinik Hagen</name>
      <address>
        <city>Hagen</city>
        <state>NRW</state>
        <zip>58091</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>November 13, 2013</last_update_submitted>
  <last_update_submitted_qc>November 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut für Pneumologie Hagen Ambrock eV</investigator_affiliation>
    <investigator_full_name>Karl Heinz Ruehle</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Arousal detection</keyword>
  <keyword>Pulse Wave Amplitude</keyword>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>Daytime sleepiness</keyword>
  <keyword>Cardiorespiratory risk</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/NCT01690429
org study id: SOMNOcheck-2012
nct id: NCT01690429
lead sponsor: 
collaborator: 
has dmc: No
Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA)
      from a finger. This can be measured using the Somnocheck micro system. A pulse wave amplitude
      decrease (PWAD) is considered to be a marker for autonomic activation. Detecting the PWAD is
      a surrogate marker for waking reactions (arousal) which eventually will contribute to assess
      sleep disruption and resulting performance deterioration. Arousal and performance
      deterioration and its possible improvement under continuous positive airway pressure (CPAP)
      therapy will be determined in this study.
Patients from the sleep laboratory with verified obstructive sleep apnea syndrome (OSAS) will
      be asked to participate in this study.

      A device is used to determine autonomic arousal over night (SOMNOcheck micro). The Somnocheck
      micro records oxygen saturation as well as pulse frequency and breathing, and calculates an
      autonomic arousal index (AAI). Somnocheck measurements will take place in two nights
      (baseline and with CPAP) and parallel to a standard polysomnography (PSG). The PSG provides
      data to analyze the arousal frequency according to ASDA rules, which will then be compared to
      the AAI.

      Performance is determined twice (prior and after CPAP therapy) by the use of a steering
      simulator programme (DASS). Differences in arousal will be correlated with differences in
      performance (deviation from the road, reaction time). The subjects are also asked to fill out
      the Epworth Sleepiness Scale (ESS) twice, prior and after therapy. Aim is to compare
      Somnocheck and PSG measurements and daytime sleepiness with DASS and ESS.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: pulse wave amplitude (PWA)
time frame: 8 hours
arm group label: OSA Patients
arm group type: Other
intervention type: Device
intervention name: Somnocheck micro
description: Study nights in sleep lab with standard polysomnography plus Somnocheck micro. The Somnocheck micro is a device with pulse oxymetry and nasal cannula, which can be worn like a wristwatch. It records information about sleep disordered breathing, oxygen saturation, and pulse wave.
arm group label: OSA Patients
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Karl Heinz Rühle, Prof. Dr.
role: Principal Investigator
affiliation: Helios Klinik Hagen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Institut für Pneumologie Hagen Ambrock eV
investigator full name: Karl Heinz Ruehle
investigator title: Principal Investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive