<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/NCT04407949</url>
  </required_header>
  <id_info>
    <org_study_id>EventLab</org_study_id>
    <nct_id>NCT04407949</nct_id>
  </id_info>
  <brief_title>Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device &quot;prismaLine&quot; With Polysomnography</brief_title>
  <official_title>Untersuchung Der Übereinstimmung Der Ereigniserkennung Von &quot;prismaLine&quot; Geräten Mit Der Polysomnographie</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut für Pneumologie Hagen Ambrock eV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heinen und Löwenstein GmbH &amp; 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway&#xD;
      pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP&#xD;
      machines with manual scored polysomnography (PSG).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The evaluation of residual sleep disordered breathing (SDB) in sleep apnea (SA) after&#xD;
      initiation of continuous positive airway pressure (CPAP) therapy is important to verify the&#xD;
      therapeutic success. In clinical practice, the internal records of CPAP devices are utilized&#xD;
      to determine the therapeutic success, during either medical consultations or telemetric&#xD;
      observation.&#xD;
&#xD;
      This study was designed to evaluate the quality of SDB Event Indices (EI), which are recorded&#xD;
      by the CPAP device (Prisma, Löwenstein Medical Technology).&#xD;
&#xD;
      The detected events of a manual scored polysomnography (PSG) in the sleep laboratory will be&#xD;
      compared with the simultaneously recorded events of the CPAP device.&#xD;
&#xD;
      This shall lead to recommendations regarding the situations, and in which degree the event&#xD;
      detection of the CPAP devices may be meaningful to determine the therapeutic success of home&#xD;
      sleep apnea therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 8, 2020</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>
    <intervention_model_description>Every enrolled patient underwent a CPAP - Titration under PSG with predefined pressure steps. Afterwards breathing events are scored manually based on AASM Criteria by a trained study member. The events will be compared with the readout from the CPAP Device.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>apnea- hypopnea- index (AHI)</measure>
    <time_frame>up to 8 hours</time_frame>
    <description>Total number (N) and index (N/h) of sleep disordered breathing events (apnoeas plus hypopneas) from PSG and device log</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hypopnea index relating to oxygen desaturation</measure>
    <time_frame>up to 8 hours</time_frame>
    <description>total number of Hypopneas (N) and Index (N/h) scored under AASM criteria for hypopneas, both rules. 1A: hypopnea events with &gt;= 3% oxygen desaturation and 1B: hypopnea events with &gt;= 4% oxygen desaturation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>central and obstructive hypopnea index</measure>
    <time_frame>up to 8 hours</time_frame>
    <description>total number (N) and Index (N/h) of hypopneas scored under AASM criteria for central and obstructive hypopneas.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Sleep Apnea Syndromes</condition>
  <arm_group>
    <arm_group_label>event detection</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CPAP Treatment</intervention_name>
    <description>Comparing events from the CPAP device with the events scored in PSG</description>
    <arm_group_label>event detection</arm_group_label>
    <other_name>PrismaLine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PSG diagnostic not older than 3 month,&#xD;
&#xD;
          -  AHI&gt;15, CPAP indication,&#xD;
&#xD;
          -  age &gt;18,&#xD;
&#xD;
          -  nasal CPAP mask,&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CPAP contraindication,&#xD;
&#xD;
          -  participation in another 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_official>
    <last_name>Georg Nilius, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH</name>
      <address>
        <city>Essen</city>
        <state>NRW</state>
        <zip>45276</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 13, 2019</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</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>Georg Nilius, PD DR med</investigator_full_name>
    <investigator_title>medical director of pneumologic department</investigator_title>
  </responsible_party>
  <keyword>CPAP</keyword>
  <keyword>Apnea</keyword>
  <keyword>Hypopnea</keyword>
  <keyword>event detection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</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/NCT04407949
org study id: EventLab
nct id: NCT04407949
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway
      pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP
      machines with manual scored polysomnography (PSG).
The evaluation of residual sleep disordered breathing (SDB) in sleep apnea (SA) after
      initiation of continuous positive airway pressure (CPAP) therapy is important to verify the
      therapeutic success. In clinical practice, the internal records of CPAP devices are utilized
      to determine the therapeutic success, during either medical consultations or telemetric
      observation.

      This study was designed to evaluate the quality of SDB Event Indices (EI), which are recorded
      by the CPAP device (Prisma, Löwenstein Medical Technology).

      The detected events of a manual scored polysomnography (PSG) in the sleep laboratory will be
      compared with the simultaneously recorded events of the CPAP device.

      This shall lead to recommendations regarding the situations, and in which degree the event
      detection of the CPAP devices may be meaningful to determine the therapeutic success of home
      sleep apnea therapy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Every enrolled patient underwent a CPAP - Titration under PSG with predefined pressure steps. Afterwards breathing events are scored manually based on AASM Criteria by a trained study member. The events will be compared with the readout from the CPAP Device.
primary purpose: Diagnostic
masking: None (Open Label)
measure: apnea- hypopnea- index (AHI)
time frame: up to 8 hours
description: Total number (N) and index (N/h) of sleep disordered breathing events (apnoeas plus hypopneas) from PSG and device log
measure: hypopnea index relating to oxygen desaturation
time frame: up to 8 hours
description: total number of Hypopneas (N) and Index (N/h) scored under AASM criteria for hypopneas, both rules. 1A: hypopnea events with >= 3% oxygen desaturation and 1B: hypopnea events with >= 4% oxygen desaturation.
measure: central and obstructive hypopnea index
time frame: up to 8 hours
description: total number (N) and Index (N/h) of hypopneas scored under AASM criteria for central and obstructive hypopneas.
arm group label: event detection
arm group type: Other
intervention type: Other
intervention name: CPAP Treatment
description: Comparing events from the CPAP device with the events scored in PSG
arm group label: event detection
other name: PrismaLine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Georg Nilius, MD
role: Principal Investigator
affiliation: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Institut für Pneumologie Hagen Ambrock eV
investigator full name: Georg Nilius, PD DR med
investigator title: medical director of pneumologic department
mesh term: Sleep Apnea Syndromes
sharing ipd: No