帕金森病中的认知与阻塞性睡眠呼吸暂停：气道正压通气的随机对照试验
Cognition and obstructive sleep apnea in Parkinson's disease: randomized controlled trial of positive airway pressure.
作者信息
Lajoie Annie C, Lafontaine Anne-Louise, Kimoff R John, Benedetti Andrea, Robinson Ann R, Létourneau Marie, Crane Joelle, Scanga Amanda, Noel Francine, Kaminska Marta
机构信息
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ), Québec, QC, Canada.
Department of Respirology and Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec, QC, Canada.
出版信息
Sleep. 2025 Jul 11;48(7). doi: 10.1093/sleep/zsaf038.
STUDY OBJECTIVES
This randomized controlled trial assessed the effects of positive airway pressure (PAP) treatment of obstructive sleep apnea (OSA) on cognition in patients with Parkinson's disease (PD).
METHODS
Individuals with PD with Montreal Cognitive Assessment (MoCA) ≤ 27 and OSA were randomized to PAP or nasal dilator strips (placebo) for 6 months. The primary outcome was the change in MoCA from baseline to 6 months compared by t-test between groups by intention to treat (ITT). Sensitivity and per protocol (PP) analyses were performed, adjusting for potential confounders. Secondary outcomes included patient-reported and motor outcomes. Exploratory outcomes comprised detailed neurocognitive tests.
FINDINGS
We randomized 94 participants (31% female) with a mean age of 67.3 (standard deviation 10.5) years, body mass index of 28.1 (4.7) kg/m2, and MoCA of 22.7 (3.5). The change in MoCA in the PAP group (n = 48) was 0.60, 95% CI [-0.08, 1.29] and in the control group (n = 46) -0.39, 95% CI [-1.21, 0.43]; between-group difference 1.00, 95% CI [-0.06, 2.05] (ITT). Adjusted ITT analyses showed improved MoCA by 1.44, 95% CI [0.09, 2.79], in treated versus control groups. In PP analyses, the adjusted between-group difference was 1.43, 95% CI [0.054, 2.81] between PAP (n = 33) versus control (n = 41) groups. Nonmotor symptoms, depression and sleep quality scores, and performance on certain executive and psychomotor tasks improved with PAP. PP analyses also showed significant improvement in motor function in PAP compared to control groups.
CONCLUSIONS
Evaluation for OSA in PD patients with reduced cognition should be considered as OSA treatment may improve cognitive function, and possibly patient-reported and motor outcomes.
CLINICAL TRIAL INFORMATION
Registered as "Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP)" at ClinicalTrials.gov. ID: NCT02209363. https://clinicaltrials.gov/study/NCT02209363?term=kaminska&rank=4.
研究目的
本随机对照试验评估了阻塞性睡眠呼吸暂停（OSA）的气道正压通气（PAP）治疗对帕金森病（PD）患者认知功能的影响。
方法
蒙特利尔认知评估量表（MoCA）评分≤27分且患有OSA的PD患者被随机分为PAP组或鼻扩张条（安慰剂）组，为期6个月。主要结局指标是在意向性分析（ITT）中，通过t检验比较两组从基线到6个月时MoCA的变化。进行敏感性分析和符合方案分析（PP），并对潜在混杂因素进行校正。次要结局指标包括患者报告结局和运动结局。探索性结局指标包括详细的神经认知测试。
研究结果
我们将94名参与者（31%为女性）进行了随机分组，其平均年龄为67.3（标准差10.5）岁，体重指数为28.1（4.7）kg/m2，MoCA评分为22.7（3.5）。PAP组（n = 48）的MoCA变化为0.60，95%置信区间[-0.08, 1.29]，对照组（n = 46）为-0.39，95%置信区间[-1.21, 0.43]；组间差异为1.00，95%置信区间[-0.06, 2.05]（ITT）。校正后的ITT分析显示，治疗组与对照组相比，MoCA改善了1.44，95%置信区间[0.09, 2.79]。在PP分析中，PAP组（n = 33）与对照组（n = 41）之间的校正组间差异为1.43，95%置信区间[0.054, 2.81]。PAP治疗可改善非运动症状、抑郁和睡眠质量评分，以及某些执行和精神运动任务的表现。PP分析还显示，与对照组相比，PAP组的运动功能有显著改善。
结论
对于认知功能减退的PD患者，应考虑评估其是否患有OSA，因为OSA治疗可能改善认知功能，以及可能改善患者报告结局和运动结局。
临床试验信息
在ClinicalTrials.gov上注册为“帕金森病中的认知与阻塞性睡眠呼吸暂停，气道正压通气治疗的效果（COPE-PAP）”。标识符：NCT02209363。https://clinicaltrials.gov/study/NCT02209363?term=kaminska&rank=4 。
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