Cognition and obstructive sleep apnea in Parkinson's disease: randomized controlled trial of positive airway pressure (COPE-PAP trial).

Abstract

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 mean age 67.3 (SD 10.5) years, body mass index 28.1 (4·7) kg/m2 and MoCA 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 vs. control groups. In PP analyses, the adjusted between-group difference was 1.43, 95%CI [0.054, 2.81] between PAP (n=33) vs. control (n=41) groups. Non-motor 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.