<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/NCT04474587</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01223</org_study_id>
    <nct_id>NCT04474587</nct_id>
  </id_info>
  <brief_title>Resting Energy Expenditure in Patients With OHS Treated With Long-term NIV</brief_title>
  <official_title>Impact of Noninvasive Ventilation on Resting Energy Expenditure in Patients With Obesity Hypoventilation Syndrome Treated by Long-term Home Noninvasive Ventilation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare, in subjects with obesity-hypoventilation syndrome (OHS) treated&#xD;
      by long-term non-invasive ventilation (NIV), resting energy expenditure (REE) in spontaneous&#xD;
      breathing and under NIV. The hypothesise of this study is that REE will be lower under NIV&#xD;
      than under spontaneous breathing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational monocentric study in which each subject will be its own control.&#xD;
      Patients' resting energy expenditure will be measured at rest (&quot;spontaneous breathing&quot;&#xD;
      condition) and under its usual treatment (&quot;under NIV&quot; condition) in a cross-over fashion.&#xD;
      Conditions measurement order will be randomly generated by a computer algorithm such that&#xD;
      half of the patients will be measured under spontaneous breathing before under NIV and the&#xD;
      other half of the patients will be measured under NIV before under spontaneous breathing.&#xD;
      Resting energy expenditure will be monitored during a short-term elective hospitalization (24&#xD;
      hours). Albeit for measurements of REE, tests which will be performed are part of the regular&#xD;
      follow-up of patients under long term NIV.&#xD;
&#xD;
      Primary objective is to compare in OHS patients the REE under spontaneous breathing and under&#xD;
      NIV, using their usual settings.&#xD;
&#xD;
      Description of the intended procedures and stages:&#xD;
&#xD;
        1. Recruitment and screening of patients fulfilling inclusion criteria will be done among&#xD;
           patients with OHS under long-term NIV followed by our center (duration: 14 days).&#xD;
&#xD;
        2. Once informed written consent has been provided, patients will be included in the study&#xD;
           protocol (time provided for decision: 28 days).&#xD;
&#xD;
        3. Patients are admitted for one night with overnight recording of nocturnal oximetry and&#xD;
           transcutaneous capnography using their noninvasive ventilation at usual settings, prior&#xD;
           to measurements of resting energy expenditure. Downloading of memorized data by&#xD;
           ventilator software will also take place and will cover the previous month and the night&#xD;
           of the study (duration: 12 hours). These procedures are part of the routine evaluation&#xD;
           of patients under long term NIV.&#xD;
&#xD;
        4. Body weight will be measured, as well as body composition by bioelectrical impedance:&#xD;
           briefly, a very low intensity electric current is sent between 2 electrodes placed on&#xD;
           the dorsum of the foot and the ipsilateral hand. Measurement of resistance and reactance&#xD;
           allows estimation of body compartments (fat-free mass and fat mass) (duration: 30&#xD;
           minutes).&#xD;
&#xD;
        5. Patients will undergo their first indirect calorimetric measurement. Prior to REE&#xD;
           measurements, patients must be fasting for at least 10 hours, in a supine position, or&#xD;
           if required for patient comfort, with a 30° inclination of head rest for at least 30&#xD;
           minutes. REE measurements are either performed with or without noninvasive ventilation&#xD;
           (conditions order will be randomized by a computer)(duration: 30 minutes of rest and&#xD;
           20-30 minutes of indirect calorimetry).&#xD;
&#xD;
        6. Interval between measurements of at least 1 hour, to avoid impact of noninvasive&#xD;
           ventilation on measurements. Between tests, they will perform pulmonary function tests&#xD;
           and have their arterialized capillary blood gases sampled at earlobe (duration: 1 hour).&#xD;
           These tests are part of the routine evaluation of patients under long term NIV.&#xD;
&#xD;
        7. Patients will undergo their second indirect calorimetric measurement (see details in&#xD;
           section on indirect calorimetric). Prior to REE measurements, patients must be fasting&#xD;
           for at least 10 hours, in a supine position, or if required for patient comfort, with a&#xD;
           30° inclination of head rest for at least 30 minutes. REE measurements are either done&#xD;
           with or without noninvasive ventilation (randomized order by a software) (duration: 30&#xD;
           minutes of rest and 20-30 minutes of indirect calorimetry).&#xD;
&#xD;
        8. These two tests will be performed in a randomized order (spontaneous breathing or&#xD;
           noninvasive ventilation).&#xD;
&#xD;
        9. Information to the patient of the results, which will also be forwarded to physician and&#xD;
           nutritionist in charge.&#xD;
&#xD;
      In 2016-2017, seventy-four OHS patients treated at home by long-term NIV were identified in&#xD;
      our area. Expecting a participation rate of around 50%, at least 30 patients will be included&#xD;
      in the present study. With such a sample size, the study will have a power of 80% to detect&#xD;
      an effect size of 0.5.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    COVID pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</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>REE</measure>
    <time_frame>Each procedure (indirect calorimetry) will take 30 minutes</time_frame>
    <description>Resting energy expenditure (REE) and will be determined under spontaneous breathing and under NIV with an indirect calorimetry</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Obesity-hypoventilation Syndrome</condition>
  <condition>Resting Energy Expenditure</condition>
  <condition>Long-term Non-invasive Ventilation</condition>
  <arm_group>
    <arm_group_label>OHS-NIV</arm_group_label>
    <description>Patients with obesity-hypoventilation syndrome (OHS) treated with non-invasive ventilation (NIV).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Indirect calorimetry</intervention_name>
    <description>Measurements of REE by indirect calorimetry</description>
    <arm_group_label>OHS-NIV</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with obesity hypoventilation syndrome (OHS) trated with non-invasive ventilation&#xD;
        (NIV).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fulfill all criteria of obesity hypoventilation syndrome.&#xD;
&#xD;
          -  Under home NIV for at least 3 months.&#xD;
&#xD;
          -  Are compliant to their treatment of NIV (defined as a daily median use &gt; 3:30 hours).&#xD;
&#xD;
          -  Have a satisfactory response to NIV (defined by a daytime PaCO2 in a sitting position&#xD;
             &lt; 6.5 kPa, and a mean nocturnal SpO2 &gt; 90%, with less than 20% of total recording time&#xD;
             spent with an SpO2 &lt; 90%).&#xD;
&#xD;
          -  Are in a stable clinical condition (i.e. no episode of acute cardiac and/or&#xD;
             respiratory failure leading to a hospitalization within the preceding 3 months).&#xD;
&#xD;
          -  Are over 18 years of age.&#xD;
&#xD;
          -  Are able to provide informed consent.&#xD;
&#xD;
          -  Agree to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presents any respiratory disorder other than OHS.&#xD;
&#xD;
          -  Has been under NIV less than 3 months.&#xD;
&#xD;
          -  Is noncompliant (defined above) and/or intolerant to NIV.&#xD;
&#xD;
          -  NIV not reaching the above-mentioned physiological targets (defined by a daytime PaCO2&#xD;
             in a sitting position &lt; 6.5 kPa, and a mean nocturnal SpO2 &gt; 90%, with less than 20%&#xD;
             of total recording time spent with an SpO2 &lt; 90%).&#xD;
&#xD;
          -  Had a recent episode of cardiac and/or respiratory failure leading to a&#xD;
             hospitalization within the preceding 3 months.&#xD;
&#xD;
          -  Is under 18 years of age.&#xD;
&#xD;
          -  Presents a situation interfering with understanding of the protocol and ability to&#xD;
             provide informed written consent (language barrier, cognitive disorder, psychiatric&#xD;
             disturbance).&#xD;
&#xD;
          -  Refuses to participate in the study.&#xD;
&#xD;
          -  Is under nocturnal oxygen supplementation on NIV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Geneva University Hospital</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>October 31, 2021</last_update_submitted>
  <last_update_submitted_qc>October 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Jean-Paul Janssens</investigator_full_name>
    <investigator_title>Jean-Paul Janssens</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoventilation</mesh_term>
    <mesh_term>Obesity Hypoventilation Syndrome</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Syndrome</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/NCT04474587
org study id: 2020-01223
nct id: NCT04474587
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to compare, in subjects with obesity-hypoventilation syndrome (OHS) treated
      by long-term non-invasive ventilation (NIV), resting energy expenditure (REE) in spontaneous
      breathing and under NIV. The hypothesise of this study is that REE will be lower under NIV
      than under spontaneous breathing.
This is an observational monocentric study in which each subject will be its own control.
      Patients' resting energy expenditure will be measured at rest ("spontaneous breathing"
      condition) and under its usual treatment ("under NIV" condition) in a cross-over fashion.
      Conditions measurement order will be randomly generated by a computer algorithm such that
      half of the patients will be measured under spontaneous breathing before under NIV and the
      other half of the patients will be measured under NIV before under spontaneous breathing.
      Resting energy expenditure will be monitored during a short-term elective hospitalization (24
      hours). Albeit for measurements of REE, tests which will be performed are part of the regular
      follow-up of patients under long term NIV.

      Primary objective is to compare in OHS patients the REE under spontaneous breathing and under
      NIV, using their usual settings.

      Description of the intended procedures and stages:

        1. Recruitment and screening of patients fulfilling inclusion criteria will be done among
           patients with OHS under long-term NIV followed by our center (duration: 14 days).

        2. Once informed written consent has been provided, patients will be included in the study
           protocol (time provided for decision: 28 days).

        3. Patients are admitted for one night with overnight recording of nocturnal oximetry and
           transcutaneous capnography using their noninvasive ventilation at usual settings, prior
           to measurements of resting energy expenditure. Downloading of memorized data by
           ventilator software will also take place and will cover the previous month and the night
           of the study (duration: 12 hours). These procedures are part of the routine evaluation
           of patients under long term NIV.

        4. Body weight will be measured, as well as body composition by bioelectrical impedance:
           briefly, a very low intensity electric current is sent between 2 electrodes placed on
           the dorsum of the foot and the ipsilateral hand. Measurement of resistance and reactance
           allows estimation of body compartments (fat-free mass and fat mass) (duration: 30
           minutes).

        5. Patients will undergo their first indirect calorimetric measurement. Prior to REE
           measurements, patients must be fasting for at least 10 hours, in a supine position, or
           if required for patient comfort, with a 30° inclination of head rest for at least 30
           minutes. REE measurements are either performed with or without noninvasive ventilation
           (conditions order will be randomized by a computer)(duration: 30 minutes of rest and
           20-30 minutes of indirect calorimetry).

        6. Interval between measurements of at least 1 hour, to avoid impact of noninvasive
           ventilation on measurements. Between tests, they will perform pulmonary function tests
           and have their arterialized capillary blood gases sampled at earlobe (duration: 1 hour).
           These tests are part of the routine evaluation of patients under long term NIV.

        7. Patients will undergo their second indirect calorimetric measurement (see details in
           section on indirect calorimetric). Prior to REE measurements, patients must be fasting
           for at least 10 hours, in a supine position, or if required for patient comfort, with a
           30° inclination of head rest for at least 30 minutes. REE measurements are either done
           with or without noninvasive ventilation (randomized order by a software) (duration: 30
           minutes of rest and 20-30 minutes of indirect calorimetry).

        8. These two tests will be performed in a randomized order (spontaneous breathing or
           noninvasive ventilation).

        9. Information to the patient of the results, which will also be forwarded to physician and
           nutritionist in charge.

      In 2016-2017, seventy-four OHS patients treated at home by long-term NIV were identified in
      our area. Expecting a participation rate of around 50%, at least 30 patients will be included
      in the present study. With such a sample size, the study will have a power of 80% to detect
      an effect size of 0.5.
observational model: Case-Only
time perspective: Prospective
measure: REE
time frame: Each procedure (indirect calorimetry) will take 30 minutes
description: Resting energy expenditure (REE) and will be determined under spontaneous breathing and under NIV with an indirect calorimetry
arm group label: OHS-NIV
description: Patients with obesity-hypoventilation syndrome (OHS) treated with non-invasive ventilation (NIV).
intervention type: Other
intervention name: Indirect calorimetry
description: Measurements of REE by indirect calorimetry
arm group label: OHS-NIV
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Jean-Paul Janssens
investigator title: Jean-Paul Janssens
mesh term: Hypoventilation
mesh term: Obesity Hypoventilation Syndrome
mesh term: Obesity
mesh term: Syndrome