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临床试验/NCT02209363
NCT02209363已完成不适用

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

McGill University Health Centre/Research Institute of the McGill University Health Centre3 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
试验地点
3
主要终点
Change in global cognitive function

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Positive airway pressure (PAP)

Experimental

Auto-adjusting positive airway pressure

干预措施: auto-adjusting positive airway pressure (Device)

nasal dilator strips

Sham Comparator

Sham treatment

干预措施: Nasal dilator strips (Other)

结局指标

主要结局

Change in global cognitive function

时间窗: 6 months

Montreal Cognitive Assessment (MoCA) - score range 0-30.

次要结局

  • 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)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Kaminska

Assistant Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (3)

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