Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy
COPE-PAP
1 other identifier
interventional
91
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 13, 2024
March 1, 2024
7.2 years
July 31, 2014
March 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in global cognitive function
Montreal Cognitive Assessment (MoCA) - score range 0-30.
6 months
Secondary Outcomes (4)
Change in non-motor symptoms of Parkinson's disease
3 months and 6 months
Change in quality of life
3 months and 6 months
Change in specific domains of neurocognitive function
3 months and 6 months
Change in global cognitive function
3 months
Other Outcomes (1)
REM sleep behaviour disorder
3 months and 6 months
Study Arms (2)
Positive airway pressure (PAP)
EXPERIMENTALAuto-adjusting positive airway pressure
nasal dilator strips
SHAM COMPARATORSham treatment
Interventions
nightly use for 6 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Significant vision or hearing impairment that could affect performance on neurocognitive assessment tasks.
- Latex allergy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Montreal Neurological Hospital and Institute
Montreal, Quebec, Canada
Related Publications (1)
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.
PMID: 39945727DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marta Kaminska, MD, MSc
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 31, 2014
First Posted
August 5, 2014
Study Start
April 1, 2015
Primary Completion
June 1, 2022
Study Completion
December 1, 2022
Last Updated
March 13, 2024
Record last verified: 2024-03