<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/NCT03003702</url>
  </required_header>
  <id_info>
    <org_study_id>16/LO/1120</org_study_id>
    <nct_id>NCT03003702</nct_id>
  </id_info>
  <brief_title>Domiciliary Monitoring to Predict Exacerbations of COPD</brief_title>
  <official_title>Domiciliary Monitoring to Predict Exacerbations of COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <brief_summary>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs&#xD;
      that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in&#xD;
      activities, patients are prone to developing chest infections called 'exacerbations'.&#xD;
      Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to&#xD;
      cause hospital admission (and therefore health facilities pressures) and death. Reducing the&#xD;
      impact of exacerbations is very important. Investigators have previously shown that earlier&#xD;
      treatment of COPD exacerbations results in faster recovery, and reduced chance of hospital&#xD;
      admission. Helping patients to detect exacerbations early is therefore important.&#xD;
      Investigators have also recently shown that monitoring heart rate and oxygen saturation via a&#xD;
      finger probe may assist in this. However, measuring these variables when the patient is awake&#xD;
      means they can be affected by other things, such as exercise and anxiety. Our new idea is&#xD;
      that measuring heart rate and oxygen level overnight, when a patient is asleep, will give the&#xD;
      best chance of detecting COPD exacerbations early and our study will test that. Investigators&#xD;
      will randomly allocate 77 patients with COPD recruited from our service in London to standard&#xD;
      monitoring, or overnight monitoring, for up to six months or the first exacerbation,&#xD;
      whichever is sooner. Investigators will then analyse whether overnight monitoring was able to&#xD;
      detect exacerbations earlier, and therefore could be used to help patients get treatment&#xD;
      earlier. A subset of participants will also wear an activity monitor overnight for the first&#xD;
      two weeks, so that Investigators can assess the effect (if any) of overnight awake periods&#xD;
      (such as trips to the bathroom) on the heart rate and saturation recording.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome is the difference in time to receive treatment from exacerbation onset as defined by symptoms, compared to exacerbation onset as defined by change in physiology</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>ETH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Overnight monitoring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTH</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Morning monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nonin</intervention_name>
    <arm_group_label>CTH</arm_group_label>
    <arm_group_label>ETH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient diagnosed with COPD (smoking history of ≥10 pack years and FEV1/VC &lt; 0.7&#xD;
             post-bronchodilator).&#xD;
&#xD;
          2. Patient who had two or more self-reported moderate or severe COPD exacerbations in the&#xD;
             past 12 months.&#xD;
&#xD;
          3. Patient who can use study equipment and attend appointments.&#xD;
&#xD;
          4. Can communicate in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient who was diagnosed with obstructive sleep apnea (through a self-report and/or a&#xD;
             result of Stop Bang and Epworth questionnaires).&#xD;
&#xD;
          2. Patient with co-morbidity preventing taking part.&#xD;
&#xD;
          3. Patients already involved in an ongoing research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Free Hospital NHS</name>
      <address>
        <city>London</city>
        <zip>NW3 2PF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03003702
org study id: 16/LO/1120
nct id: NCT03003702
lead sponsor: 
Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs
      that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in
      activities, patients are prone to developing chest infections called 'exacerbations'.
      Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to
      cause hospital admission (and therefore health facilities pressures) and death. Reducing the
      impact of exacerbations is very important. Investigators have previously shown that earlier
      treatment of COPD exacerbations results in faster recovery, and reduced chance of hospital
      admission. Helping patients to detect exacerbations early is therefore important.
      Investigators have also recently shown that monitoring heart rate and oxygen saturation via a
      finger probe may assist in this. However, measuring these variables when the patient is awake
      means they can be affected by other things, such as exercise and anxiety. Our new idea is
      that measuring heart rate and oxygen level overnight, when a patient is asleep, will give the
      best chance of detecting COPD exacerbations early and our study will test that. Investigators
      will randomly allocate 77 patients with COPD recruited from our service in London to standard
      monitoring, or overnight monitoring, for up to six months or the first exacerbation,
      whichever is sooner. Investigators will then analyse whether overnight monitoring was able to
      detect exacerbations earlier, and therefore could be used to help patients get treatment
      earlier. A subset of participants will also wear an activity monitor overnight for the first
      two weeks, so that Investigators can assess the effect (if any) of overnight awake periods
      (such as trips to the bathroom) on the heart rate and saturation recording.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The primary outcome is the difference in time to receive treatment from exacerbation onset as defined by symptoms, compared to exacerbation onset as defined by change in physiology
time frame: 6 months
arm group label: ETH
arm group type: Experimental
description: Overnight monitoring
arm group label: CTH
arm group type: Other
description: Morning monitoring
intervention type: Device
intervention name: Nonin
arm group label: CTH
arm group label: ETH
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor