<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/NCT03797794</url>
  </required_header>
  <id_info>
    <org_study_id>PESF and COPD</org_study_id>
    <nct_id>NCT03797794</nct_id>
  </id_info>
  <brief_title>Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD</brief_title>
  <official_title>The Influence of Pulsating Electrostatic Field (PESF) on Oxygen Saturation, Quality of Life and Exercise Capacity of COPD Patients, a Single Center, Double Blind, Placebo Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tjongerschans hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Center Groningen</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>
      The effect of PESF (Pulsating Electrostatic Field) on the oxygen saturation, quality of life&#xD;
      and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled&#xD;
      parallel design with 32 COPD patients GOLD III and IV with a oxygen saturation below or equal&#xD;
      to 90%.&#xD;
&#xD;
      The patients will be treated with three 30-minute PESF- or placebo-sessions distributed over&#xD;
      5 days.&#xD;
&#xD;
      Directly before the first session, oxygen saturation, quality of life (CCQuestionnaire),&#xD;
      exercise capacity (6-MWT and grip strength) and phase angle (BIA) will be measured and&#xD;
      compared to the results directly after the third session. Oxygen saturation is also monitored&#xD;
      during 24 hours after each session.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2019</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>
    <intervention_model_description>prospective, randomized, dubbel blind, placebo-controlled parallel study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of oxygen saturation</measure>
    <time_frame>5 days</time_frame>
    <description>Difference in oxygen saturation before first vs after last session</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of quality of life</measure>
    <time_frame>5 days</time_frame>
    <description>Difference in CCQ score before first vs after last session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of exercise capacity</measure>
    <time_frame>5 days</time_frame>
    <description>Difference in 6-MWT outcome before first vs after last session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of phase angle</measure>
    <time_frame>5 days</time_frame>
    <description>Difference in oxygen saturation before first vs after last session</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>PESF-treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group undergoing the pulsating electrostatic field intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo-treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The group undergoing the SHAM Pulsating Electrostatic Field</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulsating Electrostatic Field</intervention_name>
    <description>A pulsating electrostatic field is generated by the New Health 9000 (Akern). During the session the patients sits on a chair which contains the apparatus for 30 minutes.</description>
    <arm_group_label>PESF-treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SHAM Pulsating Electrostatic Field</intervention_name>
    <description>The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo.</description>
    <arm_group_label>Placebo-treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients, post-bronchodilator FEV1/FVC &lt;70% and FEV1 &lt;50% predicted&#xD;
&#xD;
          -  oxygen saturation without suppletion &lt;=90% (home use of oxygen suppletion is allowed,&#xD;
             but will be stopped during PESF-treatment)&#xD;
&#xD;
          -  Stable medication (no foreseeable need to change therapy)&#xD;
&#xD;
          -  Able to understand the purpose and method of research after adequate information and&#xD;
             the ability to decide on participation&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known malignant condition with limited life expectancy&#xD;
&#xD;
          -  Carrier of electrical equipment (pacemaker, ICD etc)&#xD;
&#xD;
          -  COPD exacerbation in the last 3 weeks&#xD;
&#xD;
          -  Woman who are pregnant or of childbearing age without effective contraception&#xD;
&#xD;
          -  Manifest acute infection&#xD;
&#xD;
          -  Patients with manifest decompensatio cordis&#xD;
&#xD;
          -  Rehabilitation/reactivation program within 2 months before or during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jaap Westbroek</last_name>
    <phone>0513-685227</phone>
    <email>j.westbroek@tjongerschans.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Huib Kerstjens</last_name>
    <email>h.a.m.kerstjens@umcg.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tjongerschans</name>
      <address>
        <city>Heerenveen</city>
        <state>Friesland</state>
        <zip>8441 PW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaap Westbroek</last_name>
      <phone>0513-685227</phone>
      <email>j.westbroek@tjongerschans.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Huib A.M. Kerstjens</investigator_full_name>
    <investigator_title>Head of the department Pulmonary diseases and Tuberculosis</investigator_title>
  </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/NCT03797794
org study id: PESF and COPD
nct id: NCT03797794
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effect of PESF (Pulsating Electrostatic Field) on the oxygen saturation, quality of life
      and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled
      parallel design with 32 COPD patients GOLD III and IV with a oxygen saturation below or equal
      to 90%.

      The patients will be treated with three 30-minute PESF- or placebo-sessions distributed over
      5 days.

      Directly before the first session, oxygen saturation, quality of life (CCQuestionnaire),
      exercise capacity (6-MWT and grip strength) and phase angle (BIA) will be measured and
      compared to the results directly after the third session. Oxygen saturation is also monitored
      during 24 hours after each session.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized, dubbel blind, placebo-controlled parallel study
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Improvement of oxygen saturation
time frame: 5 days
description: Difference in oxygen saturation before first vs after last session
measure: Improvement of quality of life
time frame: 5 days
description: Difference in CCQ score before first vs after last session
measure: Improvement of exercise capacity
time frame: 5 days
description: Difference in 6-MWT outcome before first vs after last session
measure: Improvement of phase angle
time frame: 5 days
description: Difference in oxygen saturation before first vs after last session
arm group label: PESF-treatment
arm group type: Experimental
description: The group undergoing the pulsating electrostatic field intervention
arm group label: Placebo-treatment
arm group type: Sham Comparator
description: The group undergoing the SHAM Pulsating Electrostatic Field
intervention type: Device
intervention name: Pulsating Electrostatic Field
description: A pulsating electrostatic field is generated by the New Health 9000 (Akern). During the session the patients sits on a chair which contains the apparatus for 30 minutes.
arm group label: PESF-treatment
intervention type: Device
intervention name: SHAM Pulsating Electrostatic Field
description: The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo.
arm group label: Placebo-treatment
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jaap Westbroek
phone: 0513-685227
email: j.westbroek@tjongerschans.nl
last name: Huib Kerstjens
email: h.a.m.kerstjens@umcg.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Huib A.M. Kerstjens
investigator title: Head of the department Pulmonary diseases and Tuberculosis