Clinical trial NCT02209363: Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy
Official title: Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Obstructive Sleep Apnea
Keywords: Parkinson's disease
OSA
CPAP
cognition
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: American Thoracic Society
First posted: 2014-08-05
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in global cognitive function
timeFrame: 6 months
Secondary outcomes:
measure: Change in non-motor symptoms of Parkinson's disease
timeFrame: 3 months and 6 months
measure: Change in quality of life
timeFrame: 3 months and 6 months
measure: Change in specific domains of neurocognitive function
timeFrame: 3 months and 6 months
measure: Change in global cognitive function
timeFrame: 3 months
Other outcomes:
measure: REM sleep behaviour disorder
timeFrame: 3 months and 6 months
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Hospital and Institute
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Marta Kaminska, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: