<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/NCT02230020</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00084508</org_study_id>
    <nct_id>NCT02230020</nct_id>
  </id_info>
  <brief_title>Efficacy of High Flow Therapy in COPD At Home</brief_title>
  <acronym>EHFT</acronym>
  <official_title>Efficacy of High Flow Therapy in COPD At Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand&#xD;
      during sleep. The central hypothesis of this proposal is that lowering ventilatory demand&#xD;
      using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on&#xD;
      exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT&#xD;
      over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor funding&#xD;
  </why_stopped>
  <start_date type="Actual">August 15, 2013</start_date>
  <completion_date type="Actual">December 13, 2015</completion_date>
  <primary_completion_date type="Actual">December 13, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lung Function</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Spirometry will be performed before and after each sleep study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dyspnea score</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Borg scale score before and after each sleep study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Sleep architecture assessed from sleep studies</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>St Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Nasal High Flow</arm_group_label>
    <description>All subjects are in this group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal High Flow</intervention_name>
    <arm_group_label>Nasal High Flow</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      CRP Fibrinogen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic Obstructive Pulmonary Disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Consenting adults over the age of 18 with COPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Apnea Hypopnea Index&gt;15 events/hr 2. Use of Non-invasive positive pressure&#xD;
             ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth&#xD;
             breathing at rest) 4. Documented clinical cardiovascular disease, as defined below:&#xD;
&#xD;
               1. myocardial infarction in past 3 months&#xD;
&#xD;
               2. revascularization procedure in past 3 months&#xD;
&#xD;
               3. implanted cardiac pacemaker or ICD&#xD;
&#xD;
               4. unstable arrhythmias&#xD;
&#xD;
               5. congestive heart failure with ejection fraction &lt; 40%&#xD;
&#xD;
               6. uncontrolled hypertension (BP &gt; 190/110) 5. History of end stage renal disease&#xD;
                  (on dialysis) 6. History of end stage liver disease, such as:&#xD;
&#xD;
               1. Jaundice&#xD;
&#xD;
               2. ascites&#xD;
&#xD;
               3. history of recurrent gastrointestinal bleeding&#xD;
&#xD;
               4. transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry&#xD;
                  worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by&#xD;
                  self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other&#xD;
                  than aspirin. 10. Do you take medications for any of the following reasons:&#xD;
&#xD;
               1. Pain control (besides NSAIDs)&#xD;
&#xD;
               2. Sleep medication&#xD;
&#xD;
               3. Benzodiazepines&#xD;
&#xD;
               4. Methadone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Kirkness, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</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/NCT02230020
org study id: NA_00084508
nct id: NCT02230020
lead sponsor: 
has dmc: No
Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand
      during sleep. The central hypothesis of this proposal is that lowering ventilatory demand
      using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on
      exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT
      over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.
observational model: Case-Only
time perspective: Prospective
measure: Lung Function
time frame: Baseline and 1 month
description: Spirometry will be performed before and after each sleep study
measure: Dyspnea score
time frame: Baseline and 1 month
description: Borg scale score before and after each sleep study
measure: Sleep quality
time frame: Baseline and 1 month
description: Sleep architecture assessed from sleep studies
measure: Quality of life
time frame: Baseline and 1 month
description: St Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath
arm group label: Nasal High Flow
description: All subjects are in this group
intervention type: Device
intervention name: Nasal High Flow
arm group label: Nasal High Flow
CRP Fibrinogen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Jason Kirkness, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor