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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| American Thoracic Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive airway pressure (PAP) | Experimental | Auto-adjusting positive airway pressure |
|
| nasal dilator strips | Sham Comparator | Sham treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| auto-adjusting positive airway pressure | Device | nightly use for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in global cognitive function | Montreal Cognitive Assessment (MoCA) - score range 0-30. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in non-motor symptoms of Parkinson's disease | MDS-UPDRS part 1 | 3 months and 6 months |
| Change in quality of life | PDQ-39 | 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| REM sleep behaviour disorder | Severity and frequency of symptoms in last 3 months will be assessed. | 3 months and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Kaminska, MD, MSc | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital | Montreal | Quebec | Canada | |||
| McGill University Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39945727 | Derived | Lajoie AC, Lafontaine AL, Kimoff RJ, Benedetti A, Robinson AR, Letourneau M, Crane J, Scanga A, Noel F, Kaminska M. Cognition and obstructive sleep apnea in Parkinson's disease: randomized controlled trial of positive airway pressure. Sleep. 2025 Jul 11;48(7):zsaf038. doi: 10.1093/sleep/zsaf038. |
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| Nasal dilator strips | Other | nightly use for 6 months |
|
|
| Change in specific domains of neurocognitive function | Detailed neurocognitive assessment including attention and working memory, executive function, language, memory and visuospatial function. | 3 months and 6 months |
| Change in global cognitive function | Montreal Cognitive Assessment (MoCA) | 3 months |
| Montreal |
| Quebec |
| Canada |
| Montreal Neurological Hospital and Institute | Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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