<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/NCT02209220</url>
  </required_header>
  <id_info>
    <org_study_id>APAP-21014</org_study_id>
    <nct_id>NCT02209220</nct_id>
  </id_info>
  <brief_title>Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery</brief_title>
  <acronym>APAP-CPAP</acronym>
  <official_title>Impact of Automatic Positive Airway Pressure on Treatment Compliance in Obstructive Sleep Apnea Patients Awaiting Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GROUPE DE RECHERCHE EN SANTÉ RESPIRATOIRE DE L'UNIVERSITÉ LAVAL (GESER)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Laval University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic obstruction&#xD;
      of the upper airways that causes a fall in oxygen saturation, reflex sympathetic activation&#xD;
      and sleep micro-arousals. In surgical patients, OSA is a well-known risk factor for&#xD;
      perioperative complications. At Institut Universitaire de cardiologie et de Pneumologie de&#xD;
      Quebec (IUCPQ), the investigators perform more than 450 bariatric surgeries per year.&#xD;
      Consequently, the identification and management of OSA in this high-risk surgical population&#xD;
      is an essential part of practice. Actual guidelines recommend that treatment for OSA be&#xD;
      initiated before the surgical procedure. Presently, the first line treatment for OSA is&#xD;
      continuous positive airway pressure (CPAP) therapy delivering a fixed pressure continuously&#xD;
      to maintain the patency of the upper airways. However the compliance to this therapy is poor.&#xD;
      An available alternative is automatic positive airway pressure (APAP) which delivers a&#xD;
      variable amount of pressure to prevent reduction in airflow that accompanies upper airway&#xD;
      obstruction. The APAP delivers the lowest pressure needed to prevent upper airways collapse.&#xD;
      APAP significantly reduces the mean level of pressure delivered in comparison to conventional&#xD;
      treatment. Theoretically, it seems logical that applying the lowest pressure necessary would&#xD;
      allow a better device-patient synchrony and therefore improve patient's comfort.Recent trials&#xD;
      comparing APAP and CPAP have shown that APAP is non-inferior to CPAP in controlling&#xD;
      obstructive events. APAP would be a valuable alternative if it was not for its excess cost.&#xD;
      However, APAP improves compliance to treatment in two types of population: poor compliant&#xD;
      subjects and those needing high pressure levels. The investigators know that compliance to&#xD;
      positive pressure is poor in patients without excessive daytime sleepiness, which represents&#xD;
      the majority of patient waiting bariatric surgery. Moreover, in patients needing levels of&#xD;
      pressure ≥ 10 water cm (cmH20), APAP improves treatment compliance, minimises side effects&#xD;
      and improves quality of life. The review of 180 files of OSA patients treated by CPAP who had&#xD;
      bariatric surgery in our center in 2012 demonstrated that the majority of patients needed&#xD;
      high level pressure. These values suggest that APAP could improve treatment compliance in&#xD;
      apneic patients waiting for bariatric surgery because they are usually poorly symptomatic and&#xD;
      they generally require high positive pressure level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 16, 2018</completion_date>
  <primary_completion_date type="Actual">March 16, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance of APAP and CPAP</measure>
    <time_frame>at time of surgery</time_frame>
    <description>Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean pressure level with APAP and CPAP</measure>
    <time_frame>at time of surgery</time_frame>
    <description>Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean pressure level with APAP and CPAP</measure>
    <time_frame>1 month</time_frame>
    <description>Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual apnea + hypopnea index</measure>
    <time_frame>at time of surgery</time_frame>
    <description>Number of residual respiratory events recorded by the positive pressure device during the treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual apnea + hypopnea index</measure>
    <time_frame>1 month</time_frame>
    <description>Number of residual respiratory events recorded by the positive pressure device during the treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>epworth sleepiness score</measure>
    <time_frame>at time of surgery</time_frame>
    <description>Somnolence measured by Epworth Sleepiness Scale;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life score with APAP and CPAP</measure>
    <time_frame>at time of surgery</time_frame>
    <description>Quality of life measured by Questionnaire sur la Qualité de vie du Québec</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive pressure therapy adverse events</measure>
    <time_frame>at time of surgery</time_frame>
    <description>Positive airway pressure adverse effects measured by a visual analogic scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance of APAP and CPAP</measure>
    <time_frame>1 month</time_frame>
    <description>Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Treatment Compliance</condition>
  <condition>Automatic Positive Airway Pressure</condition>
  <arm_group>
    <arm_group_label>Automatic positive airway pressure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Automatic positive airway pressure treatment of obstructive sleep apnea</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous positive airway pressure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous positive airway pressure for the treatment of obstructive sleep apnea</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Positive airway pressure for the treatment of OSA</intervention_name>
    <arm_group_label>Automatic positive airway pressure</arm_group_label>
    <arm_group_label>Continuous positive airway pressure</arm_group_label>
    <other_name>Positive pressure device used: ResMed Autoset S9.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese patients with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with additional risk factors for&#xD;
             cardiovascular disease and eligible for bariatric surgery;&#xD;
&#xD;
          -  Laparoscopic bariatric surgery planned in 2-6 months. Procedures include&#xD;
             biliopancreatic diversion with duodenal switch and sleeve gastrectomy;&#xD;
&#xD;
          -  Recent diagnosis of obstructive sleep apnea made by a sleep study. The sleep study&#xD;
             must be a overnight pulse oximetry showing a 3% desaturation index ≥ 25/hour or a&#xD;
             polysomnography with a apnea + hypopnea index (AHI) ≥ 25/hour* ;&#xD;
&#xD;
          -  No previous use of positive airway pressure device;&#xD;
&#xD;
          -  ≥18 year old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe comorbidities (respiratory, cardiac, neurologic or metabolic unstable disease);&#xD;
&#xD;
          -  Central sleep apnea;&#xD;
&#xD;
          -  Obesity hypoventilation syndrome;&#xD;
&#xD;
          -  Planned bariatric surgery by laparotomy;&#xD;
&#xD;
          -  Contraindications to positive airway pressure therapy: pneumothorax within the&#xD;
             preceding 6 months, cerebrospinal fluid leak, cranial surgery or trauma within the&#xD;
             last year.&#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>Frédéric Séries, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut universitaire de cardiologie et de pneumologie de Québec</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Kaw R, Chung F, Pasupuleti V, Mehta J, Gay PC, Hernandez AV. Meta-analysis of the association between obstructive sleep apnoea and postoperative outcome. Br J Anaesth. 2012 Dec;109(6):897-906. doi: 10.1093/bja/aes308. Epub 2012 Sep 6.</citation>
    <PMID>22956642</PMID>
  </reference>
  <reference>
    <citation>Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.</citation>
    <PMID>8464434</PMID>
  </reference>
  <reference>
    <citation>Kuna ST, Reboussin DM, Borradaile KE, Sanders MH, Millman RP, Zammit G, Newman AB, Wadden TA, Jakicic JM, Wing RR, Pi-Sunyer FX, Foster GD; Sleep AHEAD Research Group of the Look AHEAD Research Group. Long-term effect of weight loss on obstructive sleep apnea severity in obese patients with type 2 diabetes. Sleep. 2013 May 1;36(5):641-649A. doi: 10.5665/sleep.2618.</citation>
    <PMID>23633746</PMID>
  </reference>
  <reference>
    <citation>Smith I, Lasserson TJ. Pressure modification for improving usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003531. doi: 10.1002/14651858.CD003531.pub3.</citation>
    <PMID>19821310</PMID>
  </reference>
  <reference>
    <citation>Parish JM, Miller BW, Hentz JG. Autotitration positive airway pressure therapy in patients with obstructive sleep apnea who are intolerant of fixed continuous positive airway pressure. Sleep Breath. 2008 Aug;12(3):235-41. doi: 10.1007/s11325-007-0158-2. Epub 2007 Nov 28.</citation>
    <PMID>18043955</PMID>
  </reference>
  <reference>
    <citation>Wolkove N, Baltzan M, Kamel H, Dabrusin R, Palayew M. Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea. Can Respir J. 2008 Oct;15(7):365-9. doi: 10.1155/2008/534372.</citation>
    <PMID>18949106</PMID>
  </reference>
  <reference>
    <citation>Massie CA, McArdle N, Hart RW, Schmidt-Nowara WW, Lankford A, Hudgel DW, Gordon N, Douglas NJ. Comparison between automatic and fixed positive airway pressure therapy in the home. Am J Respir Crit Care Med. 2003 Jan 1;167(1):20-3. doi: 10.1164/rccm.200201-022OC. Epub 2002 Oct 4.</citation>
    <PMID>12406840</PMID>
  </reference>
  <reference>
    <citation>Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.</citation>
    <PMID>1798888</PMID>
  </reference>
  <reference>
    <citation>Lacasse Y, Bureau MP, Series F. A new standardised and self-administered quality of life questionnaire specific to obstructive sleep apnoea. Thorax. 2004 Jun;59(6):494-9. doi: 10.1136/thx.2003.011205.</citation>
    <PMID>15170032</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 1, 2019</last_update_submitted>
  <last_update_submitted_qc>August 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Frédéric Sériès</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Obstructive sleep apnea</keyword>
  <keyword>Treatment compliance</keyword>
  <keyword>Automatic positive airway pressure</keyword>
  <keyword>Continuous positive airway pressure</keyword>
  <keyword>Bariatric surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT02209220
org study id: APAP-21014
nct id: NCT02209220
lead sponsor: 
collaborator: 
has dmc: No
Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic obstruction
      of the upper airways that causes a fall in oxygen saturation, reflex sympathetic activation
      and sleep micro-arousals. In surgical patients, OSA is a well-known risk factor for
      perioperative complications. At Institut Universitaire de cardiologie et de Pneumologie de
      Quebec (IUCPQ), the investigators perform more than 450 bariatric surgeries per year.
      Consequently, the identification and management of OSA in this high-risk surgical population
      is an essential part of practice. Actual guidelines recommend that treatment for OSA be
      initiated before the surgical procedure. Presently, the first line treatment for OSA is
      continuous positive airway pressure (CPAP) therapy delivering a fixed pressure continuously
      to maintain the patency of the upper airways. However the compliance to this therapy is poor.
      An available alternative is automatic positive airway pressure (APAP) which delivers a
      variable amount of pressure to prevent reduction in airflow that accompanies upper airway
      obstruction. The APAP delivers the lowest pressure needed to prevent upper airways collapse.
      APAP significantly reduces the mean level of pressure delivered in comparison to conventional
      treatment. Theoretically, it seems logical that applying the lowest pressure necessary would
      allow a better device-patient synchrony and therefore improve patient's comfort.Recent trials
      comparing APAP and CPAP have shown that APAP is non-inferior to CPAP in controlling
      obstructive events. APAP would be a valuable alternative if it was not for its excess cost.
      However, APAP improves compliance to treatment in two types of population: poor compliant
      subjects and those needing high pressure levels. The investigators know that compliance to
      positive pressure is poor in patients without excessive daytime sleepiness, which represents
      the majority of patient waiting bariatric surgery. Moreover, in patients needing levels of
      pressure ≥ 10 water cm (cmH20), APAP improves treatment compliance, minimises side effects
      and improves quality of life. The review of 180 files of OSA patients treated by CPAP who had
      bariatric surgery in our center in 2012 demonstrated that the majority of patients needed
      high level pressure. These values suggest that APAP could improve treatment compliance in
      apneic patients waiting for bariatric surgery because they are usually poorly symptomatic and
      they generally require high positive pressure level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Compliance of APAP and CPAP
time frame: at time of surgery
description: Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
measure: Mean pressure level with APAP and CPAP
time frame: at time of surgery
description: Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
measure: Mean pressure level with APAP and CPAP
time frame: 1 month
description: Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
measure: Residual apnea + hypopnea index
time frame: at time of surgery
description: Number of residual respiratory events recorded by the positive pressure device during the treatment period
measure: Residual apnea + hypopnea index
time frame: 1 month
description: Number of residual respiratory events recorded by the positive pressure device during the treatment period
measure: epworth sleepiness score
time frame: at time of surgery
description: Somnolence measured by Epworth Sleepiness Scale;
measure: quality of life score with APAP and CPAP
time frame: at time of surgery
description: Quality of life measured by Questionnaire sur la Qualité de vie du Québec
measure: Positive pressure therapy adverse events
time frame: at time of surgery
description: Positive airway pressure adverse effects measured by a visual analogic scale.
measure: Compliance of APAP and CPAP
time frame: 1 month
description: Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
arm group label: Automatic positive airway pressure
arm group type: Active Comparator
description: Automatic positive airway pressure treatment of obstructive sleep apnea
arm group label: Continuous positive airway pressure
arm group type: Active Comparator
description: Continuous positive airway pressure for the treatment of obstructive sleep apnea
intervention type: Device
intervention name: Positive airway pressure for the treatment of OSA
arm group label: Automatic positive airway pressure
arm group label: Continuous positive airway pressure
other name: Positive pressure device used: ResMed Autoset S9.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frédéric Séries, MD
role: Principal Investigator
affiliation: Laval University
facility: 
country: Canada
citation: Kaw R, Chung F, Pasupuleti V, Mehta J, Gay PC, Hernandez AV. Meta-analysis of the association between obstructive sleep apnoea and postoperative outcome. Br J Anaesth. 2012 Dec;109(6):897-906. doi: 10.1093/bja/aes308. Epub 2012 Sep 6.
PMID: 22956642
citation: Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PMID: 8464434
citation: Kuna ST, Reboussin DM, Borradaile KE, Sanders MH, Millman RP, Zammit G, Newman AB, Wadden TA, Jakicic JM, Wing RR, Pi-Sunyer FX, Foster GD; Sleep AHEAD Research Group of the Look AHEAD Research Group. Long-term effect of weight loss on obstructive sleep apnea severity in obese patients with type 2 diabetes. Sleep. 2013 May 1;36(5):641-649A. doi: 10.5665/sleep.2618.
PMID: 23633746
citation: Smith I, Lasserson TJ. Pressure modification for improving usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003531. doi: 10.1002/14651858.CD003531.pub3.
PMID: 19821310
citation: Parish JM, Miller BW, Hentz JG. Autotitration positive airway pressure therapy in patients with obstructive sleep apnea who are intolerant of fixed continuous positive airway pressure. Sleep Breath. 2008 Aug;12(3):235-41. doi: 10.1007/s11325-007-0158-2. Epub 2007 Nov 28.
PMID: 18043955
citation: Wolkove N, Baltzan M, Kamel H, Dabrusin R, Palayew M. Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea. Can Respir J. 2008 Oct;15(7):365-9. doi: 10.1155/2008/534372.
PMID: 18949106
citation: Massie CA, McArdle N, Hart RW, Schmidt-Nowara WW, Lankford A, Hudgel DW, Gordon N, Douglas NJ. Comparison between automatic and fixed positive airway pressure therapy in the home. Am J Respir Crit Care Med. 2003 Jan 1;167(1):20-3. doi: 10.1164/rccm.200201-022OC. Epub 2002 Oct 4.
PMID: 12406840
citation: Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PMID: 1798888
citation: Lacasse Y, Bureau MP, Series F. A new standardised and self-administered quality of life questionnaire specific to obstructive sleep apnoea. Thorax. 2004 Jun;59(6):494-9. doi: 10.1136/thx.2003.011205.
PMID: 15170032
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Frédéric Sériès
investigator title: Principal investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive