<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/NCT02204865</url>
  </required_header>
  <id_info>
    <org_study_id>14/LO/0077</org_study_id>
    <nct_id>NCT02204865</nct_id>
  </id_info>
  <brief_title>Validation of the ApneaScan Algorithm in Sleep Disordered Breathing</brief_title>
  <acronym>ApneaScan</acronym>
  <official_title>Sleep-Disordered Breathing in Patients With Implanted Cardiac Devices: Validation of the ApneaScan Algorithm and Implications for Prognosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Brompton &amp; Harefield NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing&#xD;
      for periods whilst asleep, is common in heart failure and associated with a poor prognosis.&#xD;
      This study aims to validate a novel function available on certain pacemakers which is&#xD;
      designed to detect this condition.The investigators hypothesize that ApneaScan can accurately&#xD;
      detect moderate to severe sleep disordered breathing in patients with heart failure as&#xD;
      compared against an Embletta sleep study. The investigators will also follow up our patients&#xD;
      for 2 years to determine whether the severity of sleep disordered breathing as assessed by&#xD;
      ApneaScan correlates with prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      72 patients with heart failure with reduced ejection fraction (HFREF) who have been selected&#xD;
      to receive an Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization&#xD;
      Therapy Pacemaker or Defibrillator (CRT-P/D) will undergo pre-implant assessment with an&#xD;
      echocardiogram, B-type Natriuretic Peptide (BNP) level, 6 minute walk test, Minnesota living&#xD;
      with heart failure and Epworth sleepiness questionnaires. The patients will then have the&#xD;
      device implanted. 6 to 8 weeks later the patent will undergo an Embletta home sleep study and&#xD;
      download of the ApneaScan data from the device. The mean Apnoea-Hypopnoea Index (AHI) from&#xD;
      the ApneaScan download will be compared with that derived from the sleep study. The patients&#xD;
      will also have a repeat 6 minute walk test, echocardiogram and BNP level.&#xD;
&#xD;
      2 years after device implantation, all patients will be followed up to document deaths,&#xD;
      hospital admissions, Atrial Fibrillation (AF) burden and appropriate therapies from ICD&#xD;
      devices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</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>The Apnoeic-Hypopnoeic Index (AHI)</measure>
    <time_frame>18 months</time_frame>
    <description>We will compare that AHI from the ApneaScan pacemaker algorithm against the AHI from an Embletta sleep study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse heart failure events</measure>
    <time_frame>2 years</time_frame>
    <description>Comprising hospital admissions for heart failure, AF burden, VF and VT burden and mortality</description>
  </secondary_outcome>
  <other_outcome>
    <measure>B-Type Natriuretic peptide (BNP) concentration</measure>
    <time_frame>2 years</time_frame>
    <description>BNP concentration correlated with severity of SDB</description>
  </other_outcome>
  <other_outcome>
    <measure>Ejection fraction on echocardiography</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation of ejection fraction and severity of SDB</description>
  </other_outcome>
  <other_outcome>
    <measure>6 minute walk test distance</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation between 6MWTd and severity of SDB</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Sleep-Disordered Breathing</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Pacemaker/ICD with ApneaScan</arm_group_label>
    <description>Patients with HFREF due to receive a pacemaker or ICD with ApneaScan function</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pacemaker/ICD</intervention_name>
    <description>Implantation of an ICD or CRT device with ApneaScan function</description>
    <arm_group_label>Pacemaker/ICD with ApneaScan</arm_group_label>
    <other_name>Invive, Inliven, Incepta, Energen, Autogen devices.</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with heart failure with reduced ejection fraction (EF &lt;40%) due to receive a&#xD;
        Boston Scientific ICD/CRTD/P with ApneaScan function.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heart failure with reduced ejection fraction (EF &lt; 40%)&#xD;
&#xD;
          -  Due to receive a device with ApneaScan function&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Ambulatory&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known sleep disordered breathing on Non-Invasive Ventilation therapy.&#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>Ali Vazir, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton &amp; Harefield NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Simon G Pearse, MBChB</last_name>
    <phone>02073528121</phone>
    <phone_ext>2003</phone_ext>
    <email>s.pearse@rbht.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ali Vazir, MBBS</last_name>
    <phone>02073528121</phone>
    <phone_ext>7716</phone_ext>
    <email>a.vazir@imperial.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Brompton and Harefield NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon G Pearse, MBChB</last_name>
      <phone>02073528121</phone>
      <phone_ext>2003</phone_ext>
      <email>s.pearse@rbht.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Ali Vazir, PhD</last_name>
      <phone>02073528121</phone>
      <phone_ext>2060</phone_ext>
      <email>a.vazir@imperial.ac.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Simon G Pearse, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ali Vazir, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martin Cowie, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Polkey, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rakesh Sharma, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tom Wong, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>April 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>November 8, 2016</last_update_submitted>
  <last_update_submitted_qc>November 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleep-Disordered Breathing</keyword>
  <keyword>Sleep Apnoea</keyword>
  <keyword>Heart failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Heart Failure</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/NCT02204865
org study id: 14/LO/0077
nct id: NCT02204865
lead sponsor: 
collaborator: 
has dmc: Yes
Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing
      for periods whilst asleep, is common in heart failure and associated with a poor prognosis.
      This study aims to validate a novel function available on certain pacemakers which is
      designed to detect this condition.The investigators hypothesize that ApneaScan can accurately
      detect moderate to severe sleep disordered breathing in patients with heart failure as
      compared against an Embletta sleep study. The investigators will also follow up our patients
      for 2 years to determine whether the severity of sleep disordered breathing as assessed by
      ApneaScan correlates with prognosis.
72 patients with heart failure with reduced ejection fraction (HFREF) who have been selected
      to receive an Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization
      Therapy Pacemaker or Defibrillator (CRT-P/D) will undergo pre-implant assessment with an
      echocardiogram, B-type Natriuretic Peptide (BNP) level, 6 minute walk test, Minnesota living
      with heart failure and Epworth sleepiness questionnaires. The patients will then have the
      device implanted. 6 to 8 weeks later the patent will undergo an Embletta home sleep study and
      download of the ApneaScan data from the device. The mean Apnoea-Hypopnoea Index (AHI) from
      the ApneaScan download will be compared with that derived from the sleep study. The patients
      will also have a repeat 6 minute walk test, echocardiogram and BNP level.

      2 years after device implantation, all patients will be followed up to document deaths,
      hospital admissions, Atrial Fibrillation (AF) burden and appropriate therapies from ICD
      devices.
observational model: Cohort
time perspective: Prospective
measure: The Apnoeic-Hypopnoeic Index (AHI)
time frame: 18 months
description: We will compare that AHI from the ApneaScan pacemaker algorithm against the AHI from an Embletta sleep study.
measure: Adverse heart failure events
time frame: 2 years
description: Comprising hospital admissions for heart failure, AF burden, VF and VT burden and mortality
measure: B-Type Natriuretic peptide (BNP) concentration
time frame: 2 years
description: BNP concentration correlated with severity of SDB
measure: Ejection fraction on echocardiography
time frame: 2 years
description: Correlation of ejection fraction and severity of SDB
measure: 6 minute walk test distance
time frame: 2 years
description: Correlation between 6MWTd and severity of SDB
arm group label: Pacemaker/ICD with ApneaScan
description: Patients with HFREF due to receive a pacemaker or ICD with ApneaScan function
intervention type: Device
intervention name: Pacemaker/ICD
description: Implantation of an ICD or CRT device with ApneaScan function
arm group label: Pacemaker/ICD with ApneaScan
other name: Invive, Inliven, Incepta, Energen, Autogen devices.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ali Vazir, PhD
role: Principal Investigator
affiliation: Royal Brompton & Harefield NHS Foundation Trust
last name: Simon G Pearse, MBChB
phone: 02073528121
phone ext: 2003
email: s.pearse@rbht.nhs.uk
last name: Ali Vazir, MBBS
phone: 02073528121
phone ext: 7716
email: a.vazir@imperial.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Respiratory Aspiration
mesh term: Sleep Apnea Syndromes
mesh term: Heart Failure