auto-adjusting positive airway pressure
Devicenightly use for 6 months
Other names: auto-CPAP, APAP, auto-PAP
NCT Number: NCT02209363
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Jewish General Hospital, Montreal, Quebec, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
nightly use for 6 months
Other names: auto-CPAP, APAP, auto-PAP
nightly use for 6 months
Other names: Breathe-right
Time frame: 6 months
Montreal Cognitive Assessment (MoCA) - score range 0-30.
Time frame: 3 months and 6 months
MDS-UPDRS part 1
Time frame: 3 months and 6 months
PDQ-39
Time frame: 3 months and 6 months
Detailed neurocognitive assessment including attention and working memory, executive function, language, memory and visuospatial function.
Time frame: 3 months
Montreal Cognitive Assessment (MoCA)
Time frame: 3 months and 6 months
Severity and frequency of symptoms in last 3 months will be assessed.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Other
Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP Trial)
Acronym: COPE-PAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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