<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/NCT02209363</url>
  </required_header>
  <id_info>
    <org_study_id>4120</org_study_id>
    <nct_id>NCT02209363</nct_id>
  </id_info>
  <brief_title>Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy</brief_title>
  <acronym>COPE-PAP</acronym>
  <official_title>Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Thoracic Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive dysfunction (impaired memory, thinking, etc) frequently occurs in Parkinson's&#xD;
      disease (PD), often progresses to dementia, and profoundly affects quality of life.&#xD;
      Obstructive sleep apnea (OSA) is a common disorder in the general population that is&#xD;
      treatable with positive airway pressure (PAP) therapy. It is known to impair cognitive&#xD;
      function, but whether treatment improves cognitive function is less clear. When already&#xD;
      affected by a degenerative process like PD, the brain might be more vulnerable to the effects&#xD;
      of OSA, and more responsive to OSA treatment. To date, OSA has not been recognized as a&#xD;
      significant factor in PD. In preliminary work in PD patients, the investigators have found an&#xD;
      association between OSA and poor cognition, and cognitive improvement with PAP therapy. The&#xD;
      investigators now wish to more rigorously evaluate the effect of OSA treatment on cognitive&#xD;
      function in PD in a randomized controlled trial. The investigators primary objective is to&#xD;
      assess, in PD patients with OSA and cognitive deficit, the effect of OSA treatment on global&#xD;
      cognitive function. The investigators will also assess other non-motor symptoms of PD,&#xD;
      quality of life, and specific domains of neurocognitive function. PD patients will be&#xD;
      recruited from the McGill Movement Disorders Clinic and other Quebec Parkinson Network&#xD;
      Centres. Participants will need to have evidence of cognitive deficit and presence of OSA on&#xD;
      screening diagnostic polysomnography (sleep study). Ninety subjects will be randomly assigned&#xD;
      to PAP or nasal dilator strips. Detailed neuropsychological testing and other measurements&#xD;
      (including quality of life) will be done at baseline, 3 months and 6 months. At the end of&#xD;
      the study period, subjects will have polysomnography on their respective treatment to assess&#xD;
      efficacy with respect to OSA treatment. This study may demonstrate that a non-pharmacologic&#xD;
      intervention has the potential to have a marked beneficial impact on cognitive function and&#xD;
      quality of life in a significant proportion of PD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Actual">June 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in global cognitive function</measure>
    <time_frame>6 months</time_frame>
    <description>Montreal Cognitive Assessment (MoCA) - score range 0-30.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in non-motor symptoms of Parkinson's disease</measure>
    <time_frame>3 months and 6 months</time_frame>
    <description>MDS-UPDRS part 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>3 months and 6 months</time_frame>
    <description>PDQ-39</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in specific domains of neurocognitive function</measure>
    <time_frame>3 months and 6 months</time_frame>
    <description>Detailed neurocognitive assessment including attention and working memory, executive function, language, memory and visuospatial function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in global cognitive function</measure>
    <time_frame>3 months</time_frame>
    <description>Montreal Cognitive Assessment (MoCA)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>REM sleep behaviour disorder</measure>
    <time_frame>3 months and 6 months</time_frame>
    <description>Severity and frequency of symptoms in last 3 months will be assessed.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Positive airway pressure (PAP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Auto-adjusting positive airway pressure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nasal dilator strips</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>auto-adjusting positive airway pressure</intervention_name>
    <description>nightly use for 6 months</description>
    <arm_group_label>Positive airway pressure (PAP)</arm_group_label>
    <other_name>auto-CPAP</other_name>
    <other_name>APAP</other_name>
    <other_name>auto-PAP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nasal dilator strips</intervention_name>
    <description>nightly use for 6 months</description>
    <arm_group_label>nasal dilator strips</arm_group_label>
    <other_name>Breathe-right</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease as perMDS criteria&#xD;
&#xD;
          -  Evidence of cognitive dysfunction (clinical impression of mild cognitive impairment&#xD;
             and MOCA &lt;=27)&#xD;
&#xD;
          -  Presence of OSA (apnea-hypopnea index RDI ≥ 15/h) on screening diagnostic&#xD;
             polysomnography (PSG)&#xD;
&#xD;
          -  Stable regimen of anti-PD medication for 1 month prior&#xD;
&#xD;
          -  Adequate knowledge of English or French for completion of study assessment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oxygen saturation &lt;75% for &gt;10% of the diagnostic polysomnography as this should lead&#xD;
             to active PAP treatment&#xD;
&#xD;
          -  Other major neurological disorder&#xD;
&#xD;
          -  Unstable cardiac disease, uncontrolled hypertension, or diabetes&#xD;
&#xD;
          -  Active cancer or other disorder with an expected survival &lt; 6 months&#xD;
&#xD;
          -  Active treatment of OSA (prior diagnosis of OSA will constitute an exclusion criterion&#xD;
             only if the patient is currently being treated for the OSA)&#xD;
&#xD;
          -  Significant vision or hearing impairment that could affect performance on&#xD;
             neurocognitive assessment tasks.&#xD;
&#xD;
          -  Latex allergy.&#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>Marta Kaminska, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Neurological Hospital and Institute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 31, 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 22, 2022</last_update_submitted>
  <last_update_submitted_qc>August 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Marta Kaminska</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>OSA</keyword>
  <keyword>CPAP</keyword>
  <keyword>cognition</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>
    <mesh_term>Parkinson Disease</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/NCT02209363
org study id: 4120
nct id: NCT02209363
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Cognitive dysfunction (impaired memory, thinking, etc) frequently occurs in Parkinson's
      disease (PD), often progresses to dementia, and profoundly affects quality of life.
      Obstructive sleep apnea (OSA) is a common disorder in the general population that is
      treatable with positive airway pressure (PAP) therapy. It is known to impair cognitive
      function, but whether treatment improves cognitive function is less clear. When already
      affected by a degenerative process like PD, the brain might be more vulnerable to the effects
      of OSA, and more responsive to OSA treatment. To date, OSA has not been recognized as a
      significant factor in PD. In preliminary work in PD patients, the investigators have found an
      association between OSA and poor cognition, and cognitive improvement with PAP therapy. The
      investigators now wish to more rigorously evaluate the effect of OSA treatment on cognitive
      function in PD in a randomized controlled trial. The investigators primary objective is to
      assess, in PD patients with OSA and cognitive deficit, the effect of OSA treatment on global
      cognitive function. The investigators will also assess other non-motor symptoms of PD,
      quality of life, and specific domains of neurocognitive function. PD patients will be
      recruited from the McGill Movement Disorders Clinic and other Quebec Parkinson Network
      Centres. Participants will need to have evidence of cognitive deficit and presence of OSA on
      screening diagnostic polysomnography (sleep study). Ninety subjects will be randomly assigned
      to PAP or nasal dilator strips. Detailed neuropsychological testing and other measurements
      (including quality of life) will be done at baseline, 3 months and 6 months. At the end of
      the study period, subjects will have polysomnography on their respective treatment to assess
      efficacy with respect to OSA treatment. This study may demonstrate that a non-pharmacologic
      intervention has the potential to have a marked beneficial impact on cognitive function and
      quality of life in a significant proportion of PD patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in global cognitive function
time frame: 6 months
description: Montreal Cognitive Assessment (MoCA) - score range 0-30.
measure: Change in non-motor symptoms of Parkinson's disease
time frame: 3 months and 6 months
description: MDS-UPDRS part 1
measure: Change in quality of life
time frame: 3 months and 6 months
description: PDQ-39
measure: Change in specific domains of neurocognitive function
time frame: 3 months and 6 months
description: Detailed neurocognitive assessment including attention and working memory, executive function, language, memory and visuospatial function.
measure: Change in global cognitive function
time frame: 3 months
description: Montreal Cognitive Assessment (MoCA)
measure: REM sleep behaviour disorder
time frame: 3 months and 6 months
description: Severity and frequency of symptoms in last 3 months will be assessed.
arm group label: Positive airway pressure (PAP)
arm group type: Experimental
description: Auto-adjusting positive airway pressure
arm group label: nasal dilator strips
arm group type: Sham Comparator
description: Sham treatment
intervention type: Device
intervention name: auto-adjusting positive airway pressure
description: nightly use for 6 months
arm group label: Positive airway pressure (PAP)
other name: auto-CPAP
other name: APAP
other name: auto-PAP
intervention type: Other
intervention name: Nasal dilator strips
description: nightly use for 6 months
arm group label: nasal dilator strips
other name: Breathe-right
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marta Kaminska, MD, MSc
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Marta Kaminska
investigator title: Assistant Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Parkinson Disease