Mariangela Pierantozzi1, Fabio Placidi2, Claudio Liguori3, Maria Albanese4, Paola Imbriani1, Maria Grazia Marciani4, Nicola Biagio Mercuri5, Paolo Stanzione6, Alessandro Stefani7. 1. Movement Disorders Centre, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy. 2. Sleep Disorders Centre, Neurophysiopathology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy. 3. Sleep Disorders Centre, Neurophysiopathology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy. Electronic address: dott.claudioliguori@yahoo.it. 4. Neurology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy. 5. Sleep Disorders Centre, Neurophysiopathology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy; Neurology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy; IRCCS Santa Lucia Foundation, Rome, Italy. 6. Movement Disorders Centre, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy; Sleep Disorders Centre, Neurophysiopathology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy; IRCCS Santa Lucia Foundation, Rome, Italy. 7. Movement Disorders Centre, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy; IRCCS Santa Lucia Foundation, Rome, Italy.
Abstract
BACKGROUND/ OBJECTIVES: Growing evidence demonstrates that in Parkinson's Disease (PD) sleep disturbances are frequent and difficult to treat. Since the efficacy of rotigotine on sleep is corroborated by studies lacking polysomnography (PSG), this study explores the possible rotigotine-mediated impact on PSG parameters in PD patients. METHODS: This is a randomized, double-blind, placebo-controlled, parallel-group study to determine the efficacy of rotigotine vs placebo on PSG parameters in moderately advanced PD patients. An unusual protocol was utilized, since patches were maintained from 18:00 h to awakening, minimizing the possible diurnal impact on motor symptoms. All participants underwent sleep PSG recordings, subjective sleep questionnaires (Parkinson Disease Sleep Scale [PDSS], Pittsburgh Sleep Quality Index [PSQI]), and the assessment of early-morning motor disability. RESULTS: We evaluated 42 PD patients (Hoehn &; Yahr stages 2 and 3) with sleep impairment randomly assigned to active branch (N =21) or placebo (N = 21). Rotigotine significantly increased sleep efficiency and reduced both wakefulness after sleep onset and sleep latency compared to placebo. Moreover, the mean change in REM sleep quantity was significantly higher in the rotigotine than placebo group. The improvement of PSG parameters corresponded to the amelioration of PDSS and PSQI scores together with the improvement of patient morning motor symptoms. CONCLUSIONS: This study demonstrated the significant effect of rotigotine on sleep quality and continuity in PD patients by promoting sleep stability and increasing REM. The effectiveness of rotigotine on sleep may be ascribed to its pharmacokinetic/pharmacodynamic profile directly on both D1 and D2 receptors.
RCT Entities:
BACKGROUND/ OBJECTIVES: Growing evidence demonstrates that in Parkinson's Disease (PD) sleep disturbances are frequent and difficult to treat. Since the efficacy of rotigotine on sleep is corroborated by studies lacking polysomnography (PSG), this study explores the possible rotigotine-mediated impact on PSG parameters in PDpatients. METHODS: This is a randomized, double-blind, placebo-controlled, parallel-group study to determine the efficacy of rotigotine vs placebo on PSG parameters in moderately advanced PDpatients. An unusual protocol was utilized, since patches were maintained from 18:00 h to awakening, minimizing the possible diurnal impact on motor symptoms. All participants underwent sleep PSG recordings, subjective sleep questionnaires (Parkinson Disease Sleep Scale [PDSS], Pittsburgh Sleep Quality Index [PSQI]), and the assessment of early-morning motor disability. RESULTS: We evaluated 42 PDpatients (Hoehn & Yahr stages 2 and 3) with sleep impairment randomly assigned to active branch (N =21) or placebo (N = 21). Rotigotine significantly increased sleep efficiency and reduced both wakefulness after sleep onset and sleep latency compared to placebo. Moreover, the mean change in REM sleep quantity was significantly higher in the rotigotine than placebo group. The improvement of PSG parameters corresponded to the amelioration of PDSS and PSQI scores together with the improvement of patient morning motor symptoms. CONCLUSIONS: This study demonstrated the significant effect of rotigotine on sleep quality and continuity in PDpatients by promoting sleep stability and increasing REM. The effectiveness of rotigotine on sleep may be ascribed to its pharmacokinetic/pharmacodynamic profile directly on both D1 and D2 receptors.