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Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP)

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ClinicalTrials.gov Identifier: NCT02209363
Recruitment Status : Active, not recruiting
First Posted : August 5, 2014
Last Update Posted : August 24, 2022
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
American Thoracic Society
Information provided by (Responsible Party):
Marta Kaminska, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Obstructive Sleep Apnea Device: auto-adjusting positive airway pressure Other: Nasal dilator strips Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP Trial)
Study Start Date : April 2015
Actual Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Positive airway pressure (PAP)
Auto-adjusting positive airway pressure
Device: auto-adjusting positive airway pressure
nightly use for 6 months
Other Names:
  • auto-CPAP
  • APAP
  • auto-PAP

Sham Comparator: nasal dilator strips
Sham treatment
Other: Nasal dilator strips
nightly use for 6 months
Other Name: Breathe-right




Primary Outcome Measures :
  1. Change in global cognitive function [ Time Frame: 6 months ]
    Montreal Cognitive Assessment (MoCA) - score range 0-30.


Secondary Outcome Measures :
  1. Change in non-motor symptoms of Parkinson's disease [ Time Frame: 3 months and 6 months ]
    MDS-UPDRS part 1

  2. Change in quality of life [ Time Frame: 3 months and 6 months ]
    PDQ-39

  3. Change in specific domains of neurocognitive function [ Time Frame: 3 months and 6 months ]
    Detailed neurocognitive assessment including attention and working memory, executive function, language, memory and visuospatial function.

  4. Change in global cognitive function [ Time Frame: 3 months ]
    Montreal Cognitive Assessment (MoCA)


Other Outcome Measures:
  1. REM sleep behaviour disorder [ Time Frame: 3 months and 6 months ]
    Severity and frequency of symptoms in last 3 months will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease as perMDS criteria
  • Evidence of cognitive dysfunction (clinical impression of mild cognitive impairment and MOCA <=27)
  • Presence of OSA (apnea-hypopnea index RDI ≥ 15/h) on screening diagnostic polysomnography (PSG)
  • Stable regimen of anti-PD medication for 1 month prior
  • Adequate knowledge of English or French for completion of study assessment.

Exclusion Criteria:

  • Oxygen saturation <75% for >10% of the diagnostic polysomnography as this should lead to active PAP treatment
  • Other major neurological disorder
  • Unstable cardiac disease, uncontrolled hypertension, or diabetes
  • Active cancer or other disorder with an expected survival < 6 months
  • Active treatment of OSA (prior diagnosis of OSA will constitute an exclusion criterion only if the patient is currently being treated for the OSA)
  • Significant vision or hearing impairment that could affect performance on neurocognitive assessment tasks.
  • Latex allergy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209363


Locations
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Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Montreal Neurological Hospital and Institute
Montreal, Quebec, Canada
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Canadian Institutes of Health Research (CIHR)
American Thoracic Society
Investigators
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Principal Investigator: Marta Kaminska, MD, MSc McGill University Health Centre/Research Institute of the McGill University Health Centre
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Responsible Party: Marta Kaminska, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02209363    
Other Study ID Numbers: 4120
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Keywords provided by Marta Kaminska, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Parkinson's disease
OSA
CPAP
cognition
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders